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Home/Biologics/Stem Cell Phase IIb Trial Completed
Biologics

Stem Cell Phase IIb Trial Completed

August 27, 2014 1 min read Premium comments

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Stem Cell Phase IIb Trial Completed
Analysis of Clinical Trial / Courtesy: Cellular Biomedicine Group, Inc.
Secondary

An August 12 company news release from Cellular Biomedicine Group, Inc. (CBMG) announced that it has completed phase IIb of its clinical trial of Rejointherapy for knee osteoarthritis. Purpose of the trial was to evaluate the safety and efficacy of CBMG’s proprietary adipose-derived mesenchymal precursor cell based therapy ReJoin for knee osteoarthritis.

The Phase IIb clinical research trial was registered with the U.S. National Institutes of Health and led by Shanghai Renji Hospital, one of the largest teaching hospitals in China. The multi-center study enrolled 53 patients to participate in a randomized, single-blind trial.

The primary endpoints for the trial were knee-related pain, stiffness and function. The secondary endpoints were cartilage repair at six months. The Phase IIa clinical trial, which was completed in the fourth quarter of 2013, revealed an increase in cartilage volume as early as three months after the therapy.

William (Wei) Cao, M.D., Chief Executive Officer of CBMG, said, “The patient enrollment and treatment were carried out smoothly and completed earlier than anticipated. There have been no Severe Adverse Events. We are very pleased with the progress of ReJoin therapy Phase IIb trial. The excellent readout from the six-month follow-up of the Phase I/IIa trial makes us optimistic about the results of the Phase IIb trial, which will be announced in the first quarter of 2015.”

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

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?

8
JT
James Thornton, MDSpine Fellow · HSS

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.

5
RP
R. PatelSports Medicine · Stanford

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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