Global Stem Cells Group has announced plans to hold clinical trials, pending IRB approval, for bone marrow stem cell treatments targeting knee osteoarthritis. The trials will be held in five GSCG facilities in the U.S. and South America, with 25 patients accepted for each location.

MIAMI, March 31, 2016—Pending Institutional Review Board (IRB) approval, Global Stem Cells Group, Inc. has announced plans to conduct a multi-center, placebo controlled clinical trial to measure the safety and effectiveness of the intra-articular application of freshly isolated bone marrow stem cells for the treatment of osteoarthritis.GSCG2

The clinical trials, which will begin July 1, 2016 and run for one year, will be held in Global Stem Cell Group facilities in Buenos Aires, Argentina; Bogota, Colombia; Quito, Ecuador; Miami, Florida and Topeka, Kansas. Each center will accept 25 patients per clinical trial, and patients will receive a bone marrow stem cell injection in one knee and a placebo in the other knee..

Screen Shot 2016-03-30 at 7.04.59 PMThe trials are designed to investigate the possible beneficial effect of freshly harvested bone marrow stem cell applications on knee osteoarthritis patients in the control group. Patients will receive standard treatment of bone marrow stem cells intravenously, and will be monitored and assessed for any changes in clinical condition.

Knee osteoarthritis is a chronic, progressive condition affecting an increasing number of people, especially the elderly and obese. It is characterized by degeneration of the cartilage—the natural cushioning between joints inside the knee.

The condition is the result of the wearing away of cartilage. When this happens, the bones of the joints rub more closely against one another with less of the shock-absorbing benefits of cartilage, resulting in pain, swelling, stiffness and a decreased ability to move.

Screen Shot 2016-03-30 at 7.53.57 PMAccording to the Centers for Disease Control (CDC), knee osteoarthritis will affect 67 million people in the United States by 2030. While conventional treatments like physiotherapy or drugs offer temporary relief of clinical symptoms, total knee replacement is the closest treatment available for permanent relief, which requires invasive surgery, comes at a high cost and is not always successful. The latest advances in stem cell therapies for knee osteoarthritis are designed to restore cartilage function in the knee.

Global Stem Cells Group offers the most advanced protocols and techniques in cellular medicine from around the world.

Details of the protocol and eligibility criteria will be released upon IRB approval.

For more information on Global Stems Cell Group, 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, 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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Global Stem Cells Group has begun the manufacturing phase of 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.

MIAMI, March 31, 2016—Global Stem Cells Group, Inc. has announced that Progenikine™, its new and approved SVF closed system kit using EmCyte technology, is in the manufacturing phase and will 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 GSCG2isolated 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 regulatory requirements.

Developed in conjunction with Patrick Pennie, Emcyte CEO, and and Maritza Novas Director of Research and Development for Global Stem Cells Group, Progenikine emcyte logofuses 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.

“The Progenikine kit is the newest product designed to help Global Stem Cells Group’s mission to provide accessible products to our member clients, ensuring that more patients will be able to gain access to stem cell therapies,” says Benito Novas, GSCG CEO.

For more information on Global Stems Cell Group, 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, 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 Emcyte:

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 and 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.

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