Renji Hospital in Shanghai, a tertiary hospital affiliated with Shanghai Jiao Tong University School of Medicine, has given approval for a Phase IIb clinical trial for ReJoin. ReJoin is a human adipose-derived mesenchymal precursor cell therapy bio-engineered for knee osteoarthritis (KOA) by Cellular Biomedicine Group, Inc.
Knee OA Cell Therapy Trials in China
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The trial will test the safety and efficacy of intra-articular injections of autologous (patient’s own) ReJoin formula in order to reduce inflammation and repair damaged joint cartilage.
“The approval of our Phase IIb clinical trial design is a major milestone for Cellular Biomedicine Group, ” said company CEO William Cao, M.D. “We are pleased to receive such expeditious validation from Renji Hospital and its regulatory offices of our Phase I/IIa data package, which showed a high safety profile and positive results reflected by the osteoarthritis indices and pain indices.”
Cao said that, in addition to Shanghai’s Renji Hospital, several more leading hospitals will be joining this multicenter double-blind Phase IIb clinical trial. He expects enrollment of patients in the study to begin during the fourth quarter of 2013. Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of certain degenerative diseases. According to Cao, the firm’s developmental stem cell, progenitor cell, and immune cell projects are the result of research and development by scientists and doctors from China and the United States.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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