Cellular Biomedicine Group Inc (NASDAQ:CBMG) has completed the patient enrollment required for its Phase IIb trial to evaluate the safety and efficacy of its proprietary therapy, ReJoin, for Knee Osteoarthritis (KOA).
The Phase IIb clinical research trial for KOA is being led by Shanghai Renji Hospital in China and the multi-center study has enrolled 53 patients to participate in a randomized, single blind trial. The company said that the primary endpoints for the trial are knee-related pain, stiffness and function, as measured using the Western Ontario and McMaster Universities osteoarthritis index questionnaire.
The secondary endpoints are cartilage repair at six months by assessment of changes of the knee joint cartilage’s volume measured with quantitative magnetic resonance imaging, in addition to NRS-11, SF-36 and KSCRS scores, and the recording of any moderate to serious adverse events.
The Phase I/IIa clinical trial for the therapy was completed in the fourth quarter of 2013, with six-month follow-up data analysis concluding that ReJoin cell therapy for KOA patients was safe and revealing an increase in cartilage volume as early as three months after the therapy.
Shares in Cellular Biomedicine Group Inc (NASDAQ:CBMG) were unchanged during Thursday’s pre-trading session at $12.85. This is at the upper end of the company’s 52-week range, which has seen a share price high of $15.98 and a low of $4.24.
Cellular Biomedicine Group Inc (NASDAQ:CBMG) Completes Enrollment in Phase IIb Clinical Trial
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