CBMG Closes Patient Treatment In Phase IIb Trial For ReJoin Therapy For KOA

(RTTNews) - Cellular Biomedicine Group Inc. (CBMG) announced Tuesday that it has treated the final patient in its Phase IIb trial to further evaluate the safety and efficacy of their proprietary adipose-derived mesenchymal precursor cell or haMPC-based therapy ReJoin for Knee Osteoarthritis or KOA.

William Cao, Chief Executive Officer of the Company, said, "The patient enrollment and treatment were carried out smoothly and completed earlier than anticipated. There have been no Severe Adverse Events (SAE) observed to date. We are very pleased with the progress of ReJoinTM 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."

A Phase I/IIa twelve-month follow-up MRI readout has been completed and the company expects the official report to be available by early fourth quarter of 2014.

The Phase IIb clinical research trial for KOA is 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 this trial are knee-related pain, stiffness and function as measured using the Western Ontario and McMaster Universities or WOMAC 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 (MRI), in addition to NRS-11, SF-36 and KSCRS scores, and the recording of any moderate to serious adverse events.