Cellular Biomedicine Group Begins Stem Cell Trial for Knee Osteoarthritis

Palo Alto, Calif.-based Cellular Biomedicine Group Inc., a biomedicine firm that makes treatments for degenerative and cancerous diseases, has begun an interim 24-week clinical data from the Phase IIb trial of its Rejoin human adipose-derived mesenchymal progenitor cell (haMPC) therapy for knee osteoarthritis (KOA).

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

The primary endpoints for the Phase IIb trial of Rejoin haMPC therapy for KOA were safety and knee-related pain, stiffness and function measured using the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index questionnaire. The secondary endpoints were patient safety and cartilage repair during the 24 weeks post-cell therapy, defined through changes of both knee joints’ cartilage volume measured with 3-D SPGR quantitative magnetic resonance imaging and read with a semi-automated segmentation method (ITK-SNAP) by three independent blind researchers, two of whom came from two independent third party institutes. In addition, Visual Analogue Scale Score, Short Form 36 and Lequesne Index of Severity for OA index scores were employed to assess knee pain, quality of life and joint function.

“We are very pleased to see that the KOA IIb interim data has confirmed observations from the Phase IIa trial and change in WOMAC scores in the Rejoin treatment arm, the primary endpoint of the Phase IIb trial, to be significantly higher than the randomized control therapy group,” said Wei (William) Cao, Ph.D., B.M., CEO of Cellular Biomedicine Group “We remain optimistic about the efficacy of Rejoin treatment for KOA. With 57 million KOA patients in China, this treatment represents an opportunity to improve the quality of life for a meaningful number of patients.”

The 24-week interim data shows the primary and secondary endpoints of Rejoin therapy group have all improved significantly compared to their baseline, which has confirmed our Phase IIa report, although only the change (47.12 percent) of WOMAC, the primary endpoint, is significantly higher than that of the ARTZO control group (16.32 percent) (p=0.017). A trend of improvement of the secondary endpoints, including cartilage MRI quantification, is observable at the 24th week. The Company expects the final results to be available at the end of this year.