MIAMI LAKES, Florida—The Global Stem Cells Group (GSCG), a multi-disciplinary community of scientists and physicians collaborating to treat diseases and lessen human suffering through science, technology, and regenerative medicine, announced its participation in a new clinical trial in Miami. The trial is sponsored by InGeneron, Inc. and will provide researchers the opportunity to compare two treatment options in patients with partial-thickness rotator cuff tears (PTRCTs). Patient groups will be injected either with a single injection of adipose-derived regenerative cells (ADRCs) or a single corticosteroid injection to examine the efficacy of both treatment protocols.
The study is a prospective, double-blinded, randomized, active-controlled, multi-site, pivotal safety and superior effectiveness study in patients with symptomatic partial-thickness rotator cuff tears. Researchers will compare a single ADRC injection generated with the Transpose® RT system into the supraspinatus tendon and surrounding area to standard-of-care (SOC) corticosteroid injection into the subacromial bursa.
Up to 20 U.S. centers will be initiated to enroll in the study. Two hundred and forty six subjects will be assigned to two randomization arms: an adipose-derived regenerative cell (ADRC) injection arm (ADRC treatment arm) and the SOC corticosteroid injection arm (active control arm). All subjects will be randomly assigned to the ADRC treatment or active control arms in a 2:1 ratio.
The GSCG clinical trial is registered with the US Food and Drug Administration (FDA) and will adhere to all FDA safety protocols. The GSCG will help recruit patients for the study. The goal of the trial is to demonstrate the safety and efficacy of stem cells treatments in helping to treat patients suffering from degenerative diseases and injuries such as PTRCTs.
“The Global Stem Cells Group is committed to helping people across the globe find relief from debilitating diseases and is pleased to serve as a leader in cutting-edge research in the stem cells field,” said Benito Novas, CEO of the Global Stem Cells Group. “This clinical trial will hopefully help us achieve these goals by demonstrating the safety and efficacy of regenerative medicine treatments to physicians, patients, and regulatory bodies so that more patients are able to have access to these treatment protocols and find relief.”
To learn more about the clinical trial, visit https://clinicaltrials.gov/ct2/show/NCT03752827. To learn more about the Global Stem Cells Group and its latest efforts, visit http://www.stemcellsgroup.com/.