Cellular Biomedicine Group Inc. announced positive 48-week clinical data from the Phase IIb trial of its human adipose-derived mesenchymal progenitor cell (haMPC) therapy ReJoin for Knee Osteoarthritis (KOA). The data was presented January 12th at the 8th Annual BioTech Showcase investor conference held in San Francisco, CA. The company continues to be encouraged by the latest data from its ReJoin trials.

Objective measurement of cartilage volume by 3D SPGR quantitative magnetic resonance imaging (MRI) indicated significant increase of cartilage volume following ReJoin therapy, as opposed to further cartilage deterioration normally found in untreated patients. The company believes that the opportunity for patients to regenerate their damaged knee cartilage and improve the long-term quality of life using their own stem cells could be more preferable than undergoing drug treatment with adverse side effects or painful and invasive knee replacement surgery or other invasive surgical procedures. The positive preliminary results from these trials bring the company closer to commercialization of ReJoin therapy in China, where there are more than 57 million KOA patients with no approved KOA treatment for structure modification available.

ReJoin Phase IIb 48-week Data Analysis: The 48-week end of study data of 53 patients shows the primary and secondary endpoints of ReJoin therapy group having all improved significantly compared to their baseline, which has confirmed some of the company's Phase I/IIa results (view report here). The total WOMAC scores (consisting of pain, stiffness and function scores of joints) as a primary end point show statistical treatment significance at week 48 compared to the baseline. The total knee cartilage volume change measured by a semi-automated segmentation method (ITK-SNAP) by two different blinded researchers show significant gain of cartilage in the ReJoin group but a loss of cartilage in ARTZ@ group, reaching statistical difference between the two groups 48 weeks after therapy.

Highlights of the full 48-week follow-up data: Western Ontario and McMaster Universities Arthritis Index (WOMAC): significantly decreased by 9.48 (28.52% improvement rate) in the ReJoin group and by 6.92 (20.74% improvement rate) in the ARTZ@ control group at week 48, but there is no significant difference between the two groups. Subset analysis of subject numbers with WOMAC improvement rate = 50% and = 70% showed significant differences of ReJoin group over the ARTZ@ group at 48th week after therapy (p=0.0038 and 0.0388, respectively). 3D Spoiled Gradient-Recalled Echo (SPGR) MRI Quantitative Assessment: The cartilage volume of both knees together increased significantly by 302.06 mm3 in the ReJoin group but decreased by 125.35 mm3 in ARTZ@ group at 48 week time point after therapy, reaching high statistical difference (p=0.0007).

Visual Analog Scale (VAS): Pain relief indices as measured by VAS for the left and right knees show continued improvement at 48 week (46.51% and 47.89%) compared to 24 week (42.21% and 40.39%) over the baselines in the ReJoin group. The control ARTZ@ group has the scores of 16.47% and 10.82% at 48 week, 19.59% and 14.77% at 24 week, respectively. At both time points there were statistically and significantly better effects observed for ReJoin treatment over the ARTZ control group.

Short Form Health Survey (SF-36): The quality of life endpoint measured by SF-36 questionnaire also shows statistical improvement from the baseline at week 48 by 9.39 and week 24 by 8.30 of the ReJoin group over the ARTZ control (3.92 and 3.38, respectively), with P value of 0.010 and 0.034.