stem cells heart disease, mending a broken heart

Researchers are learning about mending a broken heart–that is, how to generate healthy heart muscle stem cells in the laboratory and then transplant those cells into patients with chronic heart disease. Preliminary research in mice and other animals indicates that bone marrow stromal cells, transplanted into a damaged heart, can have beneficial effects. Whether these cells can generate heart muscle cells or stimulate the growth of new blood vessels that repopulate the heart tissue, or help through some other mechanism is actively under investigation.

Stem Cell Research: Mending a Broken Heart

For example, injected cells may accomplish repair by secreting growth factors, rather than actually incorporating into the heart. Promising results from animal studies have served as the basis for a small number of exploratory studies in humans. Other recent studies in cell culture systems indicate that it may be possible to direct the differentiation of adult bone marrow cells into heart muscle cells.

Can Stem Cells Mend a Broken Heart? For that matter, what can stem cells do to treat all cardiovascular diseases including hypertension, coronary heart disease, stroke, and congestive heart failure? Cardiovascular disease (CVD) has ranked the number one cause of death in the United States every year since 1900 except 1918, when the nation struggled with an influenza epidemic.

Nearly 2,600 Americans die of CVD each day—roughly one person every 34 seconds. Given the country’s large aging population and the relatively dramatic recent increases in the prevalence of cardiovascular risk factors such as obesity and type 2 diabetes, CVD will be a significant health concern for decades to come.

Strategies to treat heart disease with stem cells

Cardiovascular disease can deprive heart tissue of oxygen, thereby killing cardiac muscle cells (cardiomyocytes). This loss triggers a cascade of detrimental events, including formation of scar tissue, an overload of blood flow and pressure capacity, the overstretching of viable cardiac cells attempting to sustain cardiac output leading to heart failure, and eventual death. Restoring damaged heart muscle tissue, through repair or regeneration, is therefore a potentially new strategy to treat heart failure.

The use of adult-derived stem cells for cardiac repair is an active area of research. A number of stem cell types, including cardiac stem cells that naturally reside within the heart, myoblasts (muscle stem cells), adult bone marrow-derived cells including mesenchymal cells (bone marrow-derived cells that give rise to tissues such as muscle, bone, tendons, ligaments, and adipose tissue), endothelial progenitor cells (cells that give rise to the endothelium, the interior lining of blood vessels), and umbilical cord blood cells, have been investigated as possible sources for regenerating damaged heart tissue. All have been explored in mouse or rat models, and some have been tested in larger animal models, such as pigs.

A few small studies have also been carried out in humans, usually in patients who are undergoing open-heart surgery. Several of these have demonstrated that stem cells that are injected into the circulation or directly into the injured heart tissue appear to improve cardiac function and/or induce the formation of new capillaries. The mechanism for this repair remains controversial, and the stem cells likely regenerate heart tissue through several pathways. However, the stem cell populations that have been tested in these experiments vary widely, as do the conditions of their purification and application. Although much more research is needed to assess the safety and improve the efficacy of this approach, these preliminary clinical experiments show how stem cells may one day be used to repair damaged heart tissue, thereby reducing the burden of cardiovascular disease.

Treating type I diabetes

In people who suffer from type 1 diabetes, the cells of the pancreas that normally produce insulin are destroyed by the patient’s own immune system. New studies indicate that it may be possible to direct the differentiation of human embryonic stem cells in cell culture to form insulin-producing cells that eventually could be used in transplantation therapy for persons with diabetes.

To realize the promise of novel cell-based therapies for such pervasive and debilitating diseases, scientists must be able to manipulate stem cells so that they possess the necessary characteristics for successful differentiation, transplantation, and engraftment. The following is a list of steps in successful cell-based treatments that scientists will have to learn to control to bring such treatments to the clinic. To be useful for transplant purposes, stem cells must be reproducibly made to:

  • Reproduce extensively and generate sufficient quantities of cells for making tissue.
  • Differentiate into the desired cell type(s).
  • Survive in the recipient after transplant.
  • Integrate into the surrounding tissue after transplant.
  • Function appropriately for the duration of the recipient’s life.
  • Avoid harming the recipient in any way.

Also, to avoid the problem of immune rejection, scientists are achieving good results with strategies that use the patient’s own stem cells to generate tissue that will not be rejected.

 

stem cell research

The difference between stem cell research and therapy is in the scientific evidence that supports therapeutic intervention to be beneficial for the patient.

Stem cells have the remarkable potential to develop into many different types of cells in the body during early life and growth. In addition, in many tissues, stem cells serve as a sort of internal repair system, dividing essentially without limit to replenish other cells as long as the individual is alive. When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.

Stem cell research on adult stem cells

Stem cells are distinguished from other cell types by two important characteristics. First, they are unspecialized cells capable of renewing themselves through cell division, sometimes after long periods of inactivity. Second, under certain physiologic or experimental conditions, they can be induced to become tissue- or organ-specific cells with special functions. In some organs, such as the gut and bone marrow, stem cells regularly divide to repair and replace worn out or damaged tissues. In other organs, such as the pancreas and the heart, stem cells only divide under special conditions.

Until recently, scientists primarily worked with two kinds of stem cells from animals and humans: embryonic stem cells and non-embryonic “somatic” or “adult” stem cells in stem cell research.

In 2006, researchers made a breakthrough by identifying conditions that would allow some specialized adult cells to be “reprogrammed” genetically to assume a stem cell-like state. This new type of stem cell is called induced pluripotent stem cells (iPSCs).

Stem cells are important for living organisms for many reasons. In the 3- to 5-day-old embryo, called a blastocyst, the inner cells give rise to the entire body of the organism, including all of the many specialized cell types and organs such as the heart, lungs, skin, sperm, eggs and other tissues. In some adult tissues, such as bone marrow, muscle, and brain, discrete populations of adult stem cells generate replacements for cells that are lost through normal wear and tear, injury, or disease.

Stem cell research for treating disease

Given their unique regenerative abilities, stem cells offer new potentials for treating diseases such as diabetes, and heart disease. However, much work remains to be done in the laboratory and the clinic to understand how to use these cells for cell-based therapies to treat disease, which is also referred to as regenerative or reparative medicine.

Laboratory studies of stem cells enable scientists to learn about the cells’ essential properties and what makes them different from specialized cell types. Scientists are already using stem cells in the laboratory to screen new drugs and to develop model systems to study normal growth and identify the causes of birth defects.

Research on stem cells continues to advance knowledge about how an organism develops from a single cell and how healthy cells replace damaged cells in adult organisms. Stem cell research is one of the most fascinating areas of contemporary biology, but, as with many expanding fields of scientific inquiry, research on stem cells raises scientific questions as rapidly as it generates new discoveries.

In 1964, the World Medical Association developed the Declaration of Helsinki as a statement of

ethical principles for medical research involving human subjects. It includes research on identifiable human material and data, last amended in October 2013.

According to the Helsinki Declaration, in the treatment of an individual patient where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering.

Intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.

Stem Cell Myths, Busted

stem cell myths, stem cell research

The term stem cell research gleans different reactions from people, both in the medical community and the wider public. Still an emerging science, stem cell research is shrouded by many myths and misconceptions. Here, we take on some of the most predominant myths to discuss the misconceptions and clarify the facts regarding this fast-growing branch of medicine.

Stem cell myths

Myth #1: Stem cells only come from embryos.

FACT: False. Stem cells exist in all bodies, from embryos to adults.

Embryonic stem cells come from the early embryo, and have the potential to produce all the specialized cells of the body. Because of this, they hold great promise for studying and potentially treating disease and injuries. Tissue or “adult” stem cells are found in the body throughout our lives. These cells maintain and repair many tissues in the body. Examples of these cells include blood stem cells, muscle stem cells, bone marrow stem cells, adipose tissue (fat) stem cells and skin stem cells. Some of these adult stem cells are used in established medical and aesthetic treatments.

Myth #2: Induced pluripotent stem cells (iPSCs) eliminate the need for embryonic cells

FACT: False. Research is needed on all types of cells because it is not clear which cells will be most useful for which types of application. For the foreseeable future, side-by-side research on both embryonic and induced pluripotent stem cells is needed. Global Stem Cell Group’s research and treatment products use no embryonic stem cells.

Myth #3: Stem cell research leads to cloning humans.

FACT: False. Most countries prohibit this type of cloning.

GSCG2

In most countries, even attempting to clone a  human being is illegal. Some countries do allow something called “therapeutic cloning” for the purposes of studying a disease. In this procedure, scientists isolate embryonic stem cells from a cloned blastocyst (early stage embryo) but do not transfer the blastocyst into a womb. In therapeutic cloning, the blastocyst is not transferred to a womb. Instead, embryonic stem cells are isolated from the cloned blastocyst. These stem cells are genetically matched to the donor organism for studying genetic disease. For example, stem cells could be generated using the nuclear transfer process described above, with the donor adult cell coming from a patient with diabetes or Alzheimer’s. The stem cells could be studied in the laboratory to help researchers understand what goes wrong in diseases like these.

Therapeutic cloning also could be used to generate cells that are genetically identical to a patient’s. A patient transplanted with these cells would not suffer the problems associated with transplant rejection. To date, no human embryonic stem cell lines have been derived using therapeutic cloning.


Myth #4: Adult stem cells are only found in adults

FACT: False. There are three different types of stem cells: embryonic stem cells, induced pluripotent stem cells and tissue specific stem cells. It’s the tissue stem cells that are often called “adult” stem cells, but these “adult” stem cells are found in people of all ages. (See myth #1).

Stem cell myths: research

Myth #5: Embryonic stem cell research is banned in Europe.

FACT: False. The laws vary across the EU.

stem cells, stem cell research

EU member states have diverging regulatory positions on human embryonic stem cell research. For instance, in Germany, the use of embryos for research is heavily restricted under the Embryo Protection Act (Embryonenschutzgesetz) of 1991, which makes the derivation

of embryonic stem cell lines a criminal offense. But in the UK, embryonic stem cell research is allowed, subject to licensing from the Human Fertilization and Embryology Authority (HFEA). Click here for country by country overviews for more details. Under the previous two European Framework programs (FP6 and F7), as well as the current program, Horizon 2020, human embryonic stem cell research can be funded, provided that the work is permitted by law in the country where it is to take place.

Myth #6: Stem cell research and treatment is against the law in the US.

embryonicstemcells

FACT: False. The FDA does not regulate the practice of medicine, but rather drugs and medical devices and which of these can be marketed in the US. Under federal law, cultured (grown) stem cell products are considered a drug, but are not illegal. Adult stem cells, however, are not cultured—they exist in our bodies throughout our organs, blood, skin, teeth, fat, bone marrow and other places.

Adult stem cell therapy is currently used in the United States to treat conditions such as leukemia and other illnesses. Bone marrow consists of stem cells which have been transplanted for years in the US.

Global Stem Cells Group offers stem cell treatments in countries where stem cell therapy is approved and regulated with no appreciable difference in safety record.. Stem cell therapy technology is still under review by the FDA.

Stem cell myths: therapies

Myth #7: Bone marrow is the best source of stem cells.

FACT: False. Bone marrow is just one source of stem cells. Bone marrow stem cells have been studied for decades, and have been used to treat certain types of cancer. A great deal of research has been dedicated to understanding this source of stem cells and their potential. Bone marrow contains a number of different kinds of stem cells, one of which is mesenchymastem cells. However, mesanchymal stem cells can also be found in adipose (fat) tissue at nearly 2000 times the frequency of bone marrow.

Mesenchymal cells have the capability to become different types of tissues (blood vessels, muscle tissue, etc.) and are capable of communicating with other cells. In combination with other proteins, molecules and regenerative cells found in adipose tissue, they also have the ability to reduce inflammation, regenerate damaged tissue, and grow new blood vessels, a process known as angiogenesis. Stem cells from adipose tissue are more accessible and abundant. They can be processed immediately and reintroduced into the body right away.

Myth #8: There is a risk of rejection with stem cell therapy.

FACT: False. When a patient’s stem cells are derived from his or her own body (such as fat tissue), there is no risk of rejection. In fact, studies thus far have indicated no safety issues with fat-derived autologous (from self) stem cells. Since these stem cells come from your own body, the risk of rejection is eliminated.

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stem cell treatment, stem cells, medical tourism, regenerative medicine

Global Stem Cells Group announces the launch of two new stem cell treatment clinics in the cities of Arica and Iquique in northern Chile. The facilities are part of the international biotech company’s expanding presence in Latin America.

MIAMI, May 31, 2016—Global Stem Cells Group, a leading international biotechnology company, announces the launch of operations at two new GSCG clinics in the cities of Arica and Iquique in northern Chile. The facilities are part of GSCG’s expanding presence in Latin America.

Both the Arica and Iquique clinics offer the most advanced protocols and techniques in stem cell medicine to patients from around the world.

stem cell treatment, medical tourism, stem cells, regenerative medicine

The clinics are headed by stem cell specialists Victor Perez, M.D., and Duval Aguirre, M.D., and will offer treatments in chronic degenerative conditions, Type 2 diabetes, COPD, traumatology and sports medicine.

Global Stem Cells Group, has been expanding its clinical presence throughout Latin America and worldwide by partnering with qualified physicians experienced in stem cell therapies to open new clinics. The new Arica and Iquique clinics are certified for the medical tourism market.

Global Stem Cells Group is committed to the highest standards in service and technology, expert and compassionate care, and a philosophy of exceeding the expectations of their international patients.

For more information, visit the Global Stem Cells Group website, Email bnovas@stemcellsgroup.com, or call 305-560-5337.

About the Global Stem Cells Group:

GSCG2

Global Stem Cells Group, Inc. is the parent company of six wholly owned operating companies dedicated entirely to stem cell research, training, products and solutions. Founded in 2012, the company combines dedicated researchers, physician and patient educators and solution providers with the shared goal of meeting the growing worldwide need for leading edge stem cell treatments and solutions.

With a singular focus on this exciting new area of medical research, Global Stem Cells Group and its subsidiaries are uniquely positioned to become global leaders in cellular medicine.

Global Stem Cells Groups corporate mission is to make the promise of stem cell medicine a reality for patients around the world. With each of GSCGs six operating companies focused on a separate research-based mission, the result is a global network of state-of-the-art stem cell treatments.

To view this press release live online, click here

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adimarket, Progenikine™ SVF Closed System, stem cell treatmentsm regenerative medicine

Global Stem Cells Group subsidiary Adimarket is preparing to launch Progenikine™, a new SVF closed system kit utilizing EmCyte technology, containing all the elements necessary to process adipose tissue and obtain stromal vascular fraction in a sterile environment.

Progenekine™, stem cells, stem cell ttreatment, stem cell research, medical tourism, regenerative medicine

MIAMI, May 31—Adimarket, a subsidiary of Global Stem Cells Group, Inc. is preparing to launch Progenikine™, its new and approved SVF closed system kit using EmCyte technology, and is expected to be available to physicians in July, 2016. The Progenikine kit contains all the elements necessary to process adipose tissue and obtain stromal vascular fraction (SVF) in a closed environment.

Adipose derived stem cells (ASCs) are used by physicians for a variety of indications. Most commonly, ASCs are isolated at the point of care from lipoaspirate (derived from liposuction) tissue as the stromal vascular fraction (SVF), harvested from the patient and immediately administered to the patient as an injection, or used to enrich fat grafts. Isolation of ASCs from adipose tissue is a relatively simple process performed routinely in cell biology laboratories, but isolation at the point of care for immediate clinical administration requires special methodology to prevent contamination, ensure integrity of the clinical procedure, and comply with Adimarket, Progenikine™ SVF Closed System, stem cell treatments, regenerative medicineregulatory requirements.

Developed in conjunction with Patrick Pennie, Emcyte CEO, and Maritza Novas Director of Research and Development for Global Stem Cells Group, Progenikine fuses elements from Emcyte systems with the Global Stem cells Group SVF protocols. The kit can provide a low cost, rapid and

simple alternative to traditional methods of isolating ASCs, particularly when smaller quantities are needed.

“We’re excited to launch the Progenikine kit, the newest product designed to help Global Stem Cells Group’s fulfill its m

ission to provide accessible products to our member clients,” says Benito Novas, CEO of Global Stem Cells Group. “These are the milestones that bring us closer to ensuring that more patients will be able to gain access to stem cell therapies.”

To learn more about the Progenikine kit, visit the Global Stem Cells Group website, email bnovas@stemcellsgroup.com, or call 305-560-5337.

About Global Stem Cells Group:

Global Stem Cells Group, Inc. is the parent company of six wholly owned operating companies dedicated entirely to stem cell research, training, products and solutions. Founded in 2012, the company combines dedicated researchers, physician and patient educators and solution providers with the shared goal of meeting the growing worldwide need for leading edge stem cell treatments and solutions.

With a singular focus on this exciting new area of medical research, Global Stem Cells Group and its subsidiaries are uniquely positioned to become global leaders in cellular medicine.

Global Stem Cells Groups corporate mission is to make the promise of stem cell medicine a reality for patients around the world. With each of GSCGs six operating companies focused on a separate research-based mission, the result is a global network of state-of-the-art stem cell treatments.

About Adimarket:

Adimarket, Inc., a division of the Global Stem Cells Group, is a cost-competitive online marketplace for quality regenerative medicine equipment and supplies for physicians and health care professionals.

Adimarket was founded to provide physicians and other health care professionals the tools they need to practice regenerative medicine in a medical office setting. Motivated by a firm belief in the impact the practice of stem cell medicine can have when dispensed in a doctor’s office, Adimarket provides physicians with the tools they need to provide patients with cutting edge treatments.

Adimarket’s experienced customer service representatives provide valuable guidance and advice regarding products relevant to individual practices.

About Emcyte:

stem cells, progenekine™, medical tourism, stem cell treatments, adipose stem cells

Fort Myers, Florida-based EmCyte Corporation is a leader in autologous cellular biologics with the GenesisCS Component Concentrating Systems. These systems provide patients with the best opportunity for rapid recovery an

d provide practitioners with the most advanced clinical point of care experience. EmCyte systems are developed to meet every clinical requirement, giving the physician better clinical choices. EmCyte devices have been independently reviewed and show to produce buffycoat concentrations of 6x to greater than 10x baseline in 7mLs, with yields ranging from 70 percent to greater than 90 percent

EmCyte technology allows for the safe extraction of concentrated platelets and other regenerative cell types from the patient’s own blood. These cells are then re-suspended in a small volume of the patient’s blood plasma and then applied to the treatment site.

To view this release live online, click here

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stem cells

In October, 2014, legendary hockey player Gordie Howe, then 86, was on death’s door after suffering a debilitating acute hemorrhagic, left thalamus stroke. Upon returning home from the hospital, Howe needed someone to lift him from his bed to a wheelchair and back. He couldn’t remember the names of his four children, Marty, Mark, Cathy, and Murray, and his condition continued to grow worse in subsequent weeks. According to an article in New York Magazine, when Mark took his father to get an epidural to relieve his back pain, the attending physician took one look at Gordie and asked Mark if it might be better to just let his father go. On the rare occasion when Gordie did manage to speak, he would tell his children, “Just take me out back and shoot me.”

The man for whom the term “hat trick” was coined, Howe retired from hockey at age 52 after four decades of professional play, having scored more goals than any other NHL player.  But over the past 10 years, his health declined dramatically—heart disease, dementia, and spinal stenosis—despite his family’s and physician’s best efforts to find medical solutions. After his stroke, Keith Olbermann aired a preemptive obituary on ESPN. The family made funeral plans. Murray, his youngest son, wrote a eulogy.

Experimental stem cell treatment

Around Thanksgiving, 2015, Howe’s family learned about an experimental stem cell treatment that could save his life. The plan was to inject up to 100 million neural stem cells into his spinal column in the hopes that the stem cells would migrate to his brain and help his body repair itself. Howe could improve within 24 hours, and receive the treatment anytime—just not in the United States. The procedure wasn’t FDA-approved, and Howe would have to receive the treatment at a clinic in Tijuana.

Howe’s son Murray, a radiologist, looked into the treatment and thought it was promising. The real concern was transporting the immobile Howe to Mexico. Daughter Cathy worried that he might die during the treatment, but Mark responded bluntly: “If he does die, what’s the difference? He’s going to be gone soon no matter what.”

While the family weighed the stem cell treatment idea, Howe was admitted to the hospital with severe dehydration, caused by his unwillingness to swallow. When he returned home, he still had no use of his right side, and the family assumed he would never walk again. The Howe children decided to give the stem cell treatments a try.

Two days later, the Howes flew their Dad to San Diego. In the air, Gordie grew agitated and got the attention of a flight attendant, who spent 10 minutes kneeling by his seat trying to understand something he wanted to tell her. Due to his profound memory loss, Howe didn’t know he had suffered a stroke, why he was on a plane, or where he was going. But he remembered one thing, which he managed to whisper to the fight attendant: “I was a pro hockey player.”

The next morning, Marty and Murray drove with their father across the border to Clínica Santa Clarita, where Gordie bent over a table to expose his lower back so that a needle could be inserted into his spinal canal to inject the stem cells. Howe was given two types of stem cells – neural stem cells and mesenchymal stem cells. The second type, derived from bone marrow, has anti-inflammatory properties and secretes chemicals that promote healing.

The procedure then required Howe to lie prone for eight hours. After the eight hours passed, Gordie told Murray he needed to use the bathroom and that he intended to walk there in order to do so. Since the stroke, Gordie had only managed to walk one time—10 steps, with a walker. Murray reminded his Dad that he couldn’t walk.

Recovery milestone after stem cell treatment

Howe stood up, and with Murray’s support, walked for the first time in more than a month—to the bathroom. This milestone became an oft-repeated story among the Howe family, and Gordie’s revival became an irresistible story for the sports pages. Back home, Gordie returned to something resembling the normal life of an 86-year-old. He pushed the grocery cart, helped with the dishes, and could go fishing so long as one of his sons reminded him that a tug on the line meant he needed to start reeling. The family released a video of Gordie standing stationary, firing a puck, five-hole, past his 8-year-old great-grandson. Keith Olbermann apologized for his premature obituary.

Howe’s children now had to figure out how to share his apparent recovery—a debate that proved just as contentious as their decision to fly him to Mexico for the treatment in the first place—with the world. Both Marty and Mark had played in the NHL alongside their father, but now Murray, the doctor, was giving interviews in his hospital scrubs, endorsing his father’s place in medical “miracle” history. He began referring to the stem-cell treatment as the “Gordie Howe Protocol,” and said that his Toledo-based hospital was looking into conducting an FDA-approved study of the procedure. In one interview, Murray Howe stated that “stem cells are the most promising thing in medicine since the discovery of antibiotics.”

As the story spread, the medical community started to question just how miraculous Howe’s recovery had been.

“Companies selling these products are preying on desperate and vulnerable people and exploiting their hope, much like snake-oil salesmen have done throughout most of human history,” wrote Judy Illes and Fabio Rossi, stem-cell experts at the University of British Columbia, in the Vancouver Sun. Even advocates pointed out that, though the field holds great promise, no reputable studies have shown that such a procedure should work.

And yet, for the children of ailing parents, such skepticism doesn’t matter. Murray’s response to one skeptic was, “What would you do for your father?”

Gordie Howe’s therapy would cost an average patient about $30,000.

Athletes, whether playing or retired, have a special need for the regenerative capacity that stem cells are believed to provide. Athletes break bones, strain ligaments, bash knees and wear out cartilage. If stem cells’ restorative capability is proven, they could be considered the latest form of sports medicine.

Since Howe’s treatment in late 2014, two other athletic legends have received stem cell treatments—former quarterbacks Bart Starr and John Brodie. And the rest of the population, particularly aging baby boomers, isn’t far behind.

stemcellgroupStill, while acceptance of stem cell therapy has grown, so have controversies surrounding its use. While clinical trials authorized by the U.S. Food and Drug Administration are rapidly expanding in the U.S., so are treatments outside the regulated system. Patients are going to stem cell clinics in other countries that approve stem cell therapies.

For its part, the FDA is drafting guidelines, although the U.S. and Canada still trail other countries in approving stem cell treatments.

Last year, the FDA issued draft guidelines to clarify what types of human cell therapy it regulates. The short answer: Most of them, with “limited exceptions,” according to an FDA email sent in response to questions from The San Diego Union-Tribune. These exceptions include cells or tissues that are “minimally manipulated,” not given with any other product and perform the same function in the donor as in the recipient.

All other stem cell therapies are seen as involving human cells, tissues and cellular and tissue-based products – also known as HCT/Ps – regulated by the FDA’s Center for Biologics Evaluation and Research.

“We understand that determining the appropriate regulatory path for HCT/Ps can be challenging, and the FDA is working diligently to develop guidance to help sponsors and physicians understand how to apply federal regulations to this complex and emerging field,” the agency said.

In January 2015, University of California, Davis stem cell researcher and blogger Paul Knoepfler estimated that more than 100 unauthorized stem cell clinics were operating in the United States. Later that year, he increased that estimate to up to 200.

Then on May 6, he wrote in his blog: “We are seeing a flood of professional athletes getting stem cell treatments in the past few years.”

Athletes and others who want these treatments bristle at what they call cumbersome, time-consuming regulations in the U.S. The situation can be urgent for seriously ill patients.

While it hasn’t been proven that the stem cells enabled his recovery, by all indications Gordie Howe’s health has improved significantly since receiving stem cell treatments. In November, 2015, Murray Howe said that his father’s physicians in the U.S. recommended hospice care in the weeks after the stroke, and the family was told he wouldn’t last more than two or three weeks,

“Then, suddenly, he is raking and sweeping and goofing around in the back yard,” Murray said.

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Sources: The San Diego Union-Tribune, New York Magazine

MIAMI, April 30, 2016–Global Stem Cells Group CEO Benito Novas announced that the University of Santiago has become the latest GSCG affiliate to apply for Regenerative Technologies Alliance (RTA) certification. RTA certification represents the highest standards of excellence in current medical and laboratory practices against established standards.

The announcement comes less than a week after Global Stem Cells Group announced a mutual endorsement for an Asian-Pacific alliance with the university to host a regenerative medicine and stem cell symposium July 1-2 at the GSCG2university’s Santiago campus. Through the alliance, the two organizations have established a working agenda for collaborative initiatives and educational programs in stem cell and regenerative medicine research and development for 2016 – 2020.

Experts in the field of regenerative and cell-based medicine conduct the RTA certification program. The Regenerative Technologies Alliance, a 501(c)3 non-profit organization operated by Regenetech and supported by individuals and institutions committed to bringing peer oversight and transparency to the regenerative and cell-based medicine industry, provides certification for:

  • Laboratory Facilities that provide the processing of human tissue for the development of cell-based applications
  • Clinical facilities seeking to participate in authorized studies that are approved by Institutional Review Boards (IRB)
  • Medical facilities providing cell-based medical therapies to patients.

Regenetech RTA certificationAccording to Benito Novas, CEO of Global Stem Cells Group, the certification process will be conducted under the direction of David B. Audley, RTA Chair and General Secretary. Audley is a highly regarded medical marketing and management services consultant who co-founded MedTourGlobal after 10 years in the emerging field of regenerative medicine.

Santiago was the city chosen for the first RTA accreditation in Latin America. This type of accreditation differs from traditional accreditation processes in that it examines all aspects of service and patient care, considers the progress of the location and the potential for receiving international patients, as well as meeting quality expectations.

The alliance between Global Stem Cells Group and the University of Santiago extended an invitation to Audley and started the RTA application and review process to assess the reception, harvesting, bio-processing and application of stem cells, in the university’s Biotechnology and Molecular Biology Laboratory and Providencia Stem Cells Center. This international certification opportunity includes evaluating and reinforcing physicians working in those areas, and validating the processes and bio-technological resources against international standards.

RTA delegates are expected to visit the University of Santiago facility in July to conduct a physical inspection of the premises. The goal is to create a cell therapy hub in Santiago that can accommodate the needs of patients in neighboring countries seeking stem cell and regenerative medicine treatments. Strong patient demand in the United States and Europe have also created a growing interest in the medical tourism industry.

Global Stem Cells Group Chief Medical Officer Enrique Testart, M.D., heads a medical and scientific team tasked with establishing a new edition of the post-graduate diploma program, “Diplomat in Cell Therapy and Tissue Engineering” at Santiago University.
The theoretical and practical, 120-hour program will deliver the fundamentals of the most advanced cell therapies and clinical applications currently practiced safely and effectively in more than 35 cities worldwide.

Testart and Novas have collaborated on the push to highlight Chile’s appeal as a destination for patients seeking stem cell therapies for a variety of conditions, and as part of GSCG’s ongoing commitment to expand the reach of stem cell treatments throughout Latin America. Global Stem Cells Group’s Quito, Chile clinical facility is also in the process of earning RTA certification.

Novas says that GSCG aims to have all the company’s clinical facilities earn RTA certification by the end of 2016.

Global Stem Cells Group’s presence in Chile represents one of the largest integrated science and technology organizations associated with tissue engineering and tissue regeneration. GSCG represents the areas of research, development, medical appliances, equipment and protocols for clinical standards, and is fast becoming a global leader in adult stem cell therapies, medical training in stem cell protocols, and the manufacture of high quality products and supplies in regenerative medicine.

Their strategic leadership puts them in the forefront of stem cell research, medical education and patient care. Global Stem Cells Group comprises six companies, each of which works in specialty areas related to the stem cell industry .

To learn more, visit the Global Stem Cells Group website, Email bnovas(at)stemcellsgroup(dot)com, or call 305-560-5337.

About Global Stem Cells Group:

Global Stem Cells Group, Inc. is the parent company of six wholly owned operating companies dedicated entirely to stem cell research, training, products and solutions. Founded in 2012, the company combines dedicated researchers, physician and patient educators and solution providers with the shared goal of meeting the growing worldwide need for leading edge stem cell treatments and solutions. With a singular focus on this exciting new area of medical research, Global Stem Cells Group and its subsidiaries are uniquely positioned to become global leaders in cellular medicine.

Global Stem Cells Group’s corporate mission is to make the promise of stem cell medicine a reality for patients around the world. With each of GSCG’s six operating companies focused on a separate research-based mission, the result is a global network of state-of-the-art stem cell treatments.

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cell assisted fat transfer

MIAMI, April 30, 2016–Global Stem Cells Group and Stem Cell Training, Inc. have announced the addition of a cell assisted fat transfer training course, to be conducted by Alfredo Hoyos, M.D., head of the GSCG Advisory Board, and Enrique Testart, M.D., GSCG Chief Medical Officer.

Two courses are scheduled, one to be conducted in Santiago, Chile August 23-24, and the other in Cancun, Mexico October 11-12.

The training course involves facial fat transfer injection combined with adipose-derived stem cells, to address the primary issues that concern patients in the aesthetic field, including facial aging caused by volume loss.

Hoyos is a plastic surgeon and stem cell expert who founded Stemlab, a Bogota, Colombia facility that conducts extensive research in regenerative medicine in an effort to establish stem cell treatments that can repair damaged tissue in living organisms.

Alfredo Hoyos, MD

Alfredo Hoyos, MD

Stemlab works to further the development of aesthetic techniques using stromal stem cells derived from adipose tissue. Hoyos is the inventor of high definition liposculpture (HDL) and dynamic definition lipoplasty (4D) techniques as well as other advanced techniques that focus on body contouring.

Testart is a surgeon specializing in child trauma microsurgery. He is also a medical entrepreneur and founder of Consortia Innovas S.A. in Santiago, Chile, an organization dedicated to consulting and clinical health management for clinical management firms and research and development-oriented planners on the latest treatments in regenerative medicine as they become available.

stem cells, stem cell research, stem cells Santiago Chile

Enrique Testart, MD

Hoyos and Testart will train qualified physicians on cell assisted fat transfer techniques and protocols, during which fat cells are harvested from the patient’s own body and redistributed to other areas of the body to augment sunken or thin regions of the face or body in order to add volume where it is desired.

Lipoinjection for cosmetic treatments can be unpredictable, and has a low rate of graft survival due to partial necrosis. To overcome these problems, cell assisted fat transfer (lipostransfer) was developed as a strategy wherein autologous adipose-derived stem (stromal) cells (ASCs) are used in combination with lipoinjection. A stromal vascular fraction (SVF) containing ASCs is freshly isolated from half of the aspirated fat and recombined with the other half. This process converts relatively ASC-poor aspirated fat to ASC-rich fat, reducing postoperative atrophy of injected fat to a minimal leveGSCG2l that clinical trials have found does not change substantially after 2 months. Patients walk away with soft and natural-appearing augmentation.

Cell assisted fat transfer is a promising treatment for facial rejuvenation and soft tissue augmentation because there are no incisional scars or complications associated with foreign materials.

The cell assisted fat transfer training course will be offered through Global Stem Cells Group affiliate Stem Cell

To learn more, visit the Global Stem Cells Group website, or the Stem Cell Training website, email stemcelltraining

About Global Stem Cell Group:

Global Stem Cells Group, Inc. is the parent company of six wholly owned operating companies dedicated entirely to stem cell research, training, products and solutions. Founded in 2012, the company combines dedicated researchers, physician and patient educators and solution providers with the shared goal of meeting the growing worldwide need for leading edge stem cell treatments and solutions. With a singular focus on this exciting new area of medical research, Global Stem Cells Group and its subsidiaries are uniquely positioned to become global leaders in cellular medicine.

About Stem Cell Training, Inc.:

Stem Cell Training, Inc. is a multi-disciplinary company offering coursework and training in 35 cities worldwide. The coursework offered focuses on minimally invasive techniques for harvesting stem cells from adipose tissue, bone marrow and platelet-rich plasma. By equipping physicians with these techniques, the goal is to enable them to return to their practices, better able to apply these techniques in patient treatments.

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MIAMI,  April 30, 2016–Global Stem Cells Group has announced the University of Santiago’s plans to endorse an alliance between GSCG and the university’s Biotechnology Lab to host an Asian-Pacific SymposiuGSCG2m and other initiatives for potential stem cell protocol management for 2016 – 2020. The symposium will be held July 1-2 at the university in Santiago, Chile.

In 2015, University of Santiago officials and top Global Stem Cells Group executives began meeting to establish a working agenda and foster initiatives to promote stem cell research and development as a collaborative effort.

Professor Alejandra Moenen, Ph.D., who heads the University of Santiago’s Biochemistry and Molecular Biology Department, and a team of Ph.D.s from the university will join Global Stem Cells Group to host the Asian-Pacific Symposium. Moenen is an internationally prominent researcher whose work in biological research has been published in 50 major scientific journals worldwide.

stem cell trainingThe symposium will concentrate on regenerative medicine and stem cell applications to anti-aging and aesthetic medicine. University of Santiago faculty will lead the symposium, and qualified academic and medical groups from around the world will be invited to present their scientific papers. Among them will be Duncan Ross, Ph.D., a Global Stem Cells Group Advisory Board member who will present his abstract, “The mechanism of action of stem cells in regenerative medicine is increasingly being understood to be effected through paracrine factors. Central to the question of when and how to treat an individual disease is where and for what duration a transplanted cell will persist to generate these factors.”

A meeting to confirm the Asia-Pacific Symposium alliance was attended by Kevin Maisey, Ph.D., and Jorge LaPorte, Ph.D., both representing the Biology and Biochemistry Department of the University of Santiago. University Dean Silvia Ferrada Vergara has validated the agreement, and the endorsement will be announced at the Asia-Pacific Conference in July.

For more information, visit the Global Stem Cells Group website, email bnovas(at)stemcellsgroup(dot)com, or call +1 305 560 5337.

About Global Stem Cell Group:

Global Stem Cells Group, Inc. is the parent company of six wholly owned operating companies dedicated entirely to stem cell research, training, products and solutions. Founded in 2012, the company combines dedicated researchers, physician and patient educators and solution providers with the shared goal of meeting the growing worldwide need for leading edge stem cell treatments and solutions. With a singular focus on this exciting new area of medical research, Global Stem Cells Group and its subsidiaries are uniquely positioned to become global leaders in cellular medicine.

Global Stem Cells Group’s corporate mission is to make the promise of stem cell medicine a reality for patients around the world. With each of GSCG’s six operating companies focused on a separate research-based mission, the result is a global network of state-of-the-art stem cell treatments.

About the University of Santiago:

Celebrating the 166th anniversary of its founding in 2016, the University of Santiago is one of the oldest and most traditional institutions of higher education in Chile. Offering 66 comprehensive undergraduate programs to more than 18,000 students, the university has seven faculties representing departments of Engineering, Humanities, Science, Business and Economics, Chemistry and Biology, Medical Sciences and Technology. The university us moving toward a new era of implementing improved and advanced master’s degree and doctoral degree programs, in addition to the numerous courses and postgraduate programs already in place in a variety of academic and research disciplines.

Since Chile’s 1981 higher education reform, the University of Santiago has concentrated its activities in the metropolitan area, with a particular focus on teaching, research and extension, carried out on the 34-hectare (84 acre) campus in the City of Santiago.

The University of Santiago is known for its participation in national and international projects and the contributions of its scholars to various fields of knowledge. A singular effort has been placed on linking the work of university researchers, who have a close relationship with the socio-economic needs of the country, to improve public health conditions in the country. The University of Santiago is one of Chile’s four Universities noted for successful fundraising efforts to support research and development.

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stem cell training

MIAMI, April 30, 2015–Global Stem Cells Group and the University of Santiago, Chile have announced plans to launch a new edition of the post-graduate diploma program, “Diplomat in Cell Therapy and Tissue Engineering.” The first of its kind worldwide, the program is designed for physicians and qualified practitioners to bring stem cell therapies into the doctor’s office to treat patients.

The University of Santiago, ranked among the top universities in South America, is the first state university to offer a diploma program in stem cells, tissue engineering and cell therapy.

The program concentrates on advances in cell biology, the clinical and linked characteristics to bioprocessing of stem cells derived from adipose tissue, and other stem cell-based protocols. Based on medical research that emerged in the late 20th and early 21st centuries to give rise to stem cell therapies, this is a new form of medical treatment in which cells and tissues are used as healing elements, not only to supplement or replace deficient cells, but to induce regeneration and restoration of a lost biological order during the development of a disease or injury.

GSCG2Alejandra Moenen, Ph.D., who heads the University of Santiago’s Biochemistry and Molecular Biology Department, was chosen to teach the program. Moenen is an internationally prominent researcher whose work in biological research has been published in 50 major scientific journals worldwide.

Global Stem Cells Group has established the program’s medical and scientific management team, headed by Duncan Ross, Ph.D. and Enrique Testart, M.D., to develop a theoretical and practical, 120 hour program that will deliver the fundamentals of the most advanced cell therapies and clinical applications currently practiced safely and effectively in more than 35 cities worldwide.

In a 2015 televised interview, Joseph Purita, M.D., an orthopedic surgeon, stem cell pioneer and founder of the American Academy of Regenerative Medicine, said that Santiago University has all the human and physical resources and conditions necessary to become the capital of stem cell research and advances in South America.

Purita’s foresight launched an alliance between GSCG and Santiago University that led way to building an academic program to meet the needs of physicians, engineers, biologists and biochemists required to move regenerative medicine forward.

stem cell trainingThe Diplomat in Cell Therapy and Tissue Engineering program will begin in 2016, with a first phase designed to carry it through 2020. A maximum of 15 students will make up groups who will occupy individual biological work stations, study electron microscopy, flow cytometry, real-time polymerase chain reaction (PCR) and faculty-arranged resources to make this international diploma program a recognized leader worldwide for the training of specialists in the field of stem cell medicine.

Open enrollment will begin April 30 for high-achieving medical professionals with qualified credentials, who will receive dual certification—a diploma in Cell Therapy and Tissue Engineering from the University of Santiago, and the American Certificate of Protocols from Global Stem Cells Group, and its affiliate, Stem Cell Training, Inc. The course will include practical, hands-on training during which students will apply stem cell harvesting and implantation techniques learned in the laboratory, quantify cell counts, weigh comparisons and ultimately experience stem cell therapy in all its dimensions, to use in different areas of medicine and dentistry.

“Between physicians, biologists, biochemists and engineers, we have collectively built a curriculum that is designed for the new generation of medicine,” says Testart, Global Stem Cells Group Chief Medical Officer. “But even more important, we will provide a new generation of patients with therapies that will enable them to improve their quality of life for years to come, and to enjoy the longevity given us in the modern world.”

“The Diplomat in Cell Therapy and Tissue Engineering program will offer medical professionals invaluable lessons in this new art of stem regenerative healing, as well as the scientific and practical methodologies involved in stem cell medicine,” says Benito Novas, Global Stem Cells Group CEO.

Educational strategies will be taught in theory and in practical hands-on classes, during which students can raise questions and work on problem solving.

For more information, visit the Global Stem Cells Group website, email bnovas(at)stemcellsgroup(dot)com, or call +1 305 560 5337.

About Global Stem Cells Group:

Global Stem Cells Group is the parent company of six wholly owned operating companies dedicated entirely to stem cell research, training, products and solutions. Founded in 2012, the company combines dedicated researchers, physician and patient educators and solution providers with the shared goal of meeting the growing worldwide need for leading edge stem cell treatments and solutions. With a singular focus on this exciting new area of medical research, Global Stem Cells Group and its subsidiaries are uniquely positioned to become global leaders in cellular medicine.

Global Stem Cells Group’s corporate mission is to make the promise of stem cell medicine a reality for patients around the world. With each of GSCG’s six operating companies focused on a separate research-based mission, the result is a global network of state-of-the-art stem cell treatments.

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