Sep 6, 2013
Interim Results of KOA Clinical Trial
Cellular Biomedicine Group Announces Positive Interim Results from Phase I/IIa Clinical Trial for Treatment of Knee Osteoarthritis (KOA)
Patients shown to achieve a clinically meaningful reduction in pain and increase in mobility
PALO ALTO, California/September 6, 2013/PRNewswire –Cellular Biomedicine Group, Inc. (OTCQB: CBMG) today announced the interim results of its Phase I/IIa clinical trial for human adipose-derived mesenchymal precursor cell (haMPC) therapy for Knee Osteoarthritis (KOA), which tests the safety and efficacy of intra-articular injections of autologous (patient’s own) haMPCs in order to reduce inflammation and repair damaged joint cartilage. On schedule for completion in Q4 2013, the interim analysis of the trial has preliminarily demonstrated a significant improvement (P<0.05) from the baseline in clinical scores for SF-36, NRS-11, and WOMAC osteoarthritis indices, and no serious adverse events have been reported.
“We are very pleased with the results of the trial thus far and we look forward to the full data readout before the end of the year,” said Wei (William) Cao, PhD, BM, President at Cellular Biomedicine Group. “Knee osteoarthritis severely impacts one’s quality of life, and surgical treatment is very costly and invasive. This trial’s preliminary results have encouraged us to continue with the study to further test the efficacy of this hopeful therapy to reduce pain, repair knee cartilage and improve quality of life of the patients in the next Phase II trial.”
Knee Osteoarthritis in China
There are approximately 57 million people in China suffering from knee osteoarthritis. As drug-based methods of management are ineffective, many patients with this disease will degenerate to the point of requiring invasive artificial joint replacement surgery.
About the Clinical Trial
Cellular Biomedicine Group’s Phase I/IIa clinical trial studies the safety and efficacy of CBMG’s proprietary adipose-derived mesenchymal precursor cell(haMPC)-based therapy for knee osteoarthritis. According to the interim analysis of Phase I/IIa for KOA, 24 patients were screened, and 18 of them were eligible for the inclusion criteria and enrolled in the trial with their informed consent. To date, half of the subjects have completed a total of 2 doses of intra-articular injections and the scheduled 6 follow-up observations, and no serious adverse events (SAEs) have been reported.
The trial is conducted by Shanghai’s Renji Hospital, a tertiary hospital affiliated to Shanghai Jiao Tong University School of Medicine.
“Our adipose-derived MPC therapy for KOA utilizes our proprietary medical device, the A-StromalTM Kit,” commented Li (Helen) Zhang, BM, Vice President of Technology and Manufacturing at CBMG.“With this patented kit, approved as a medical device by China’s SFDA, we use the patient’s own haMPC, which negates the need for immunosuppression or donor matching. In addition, our proprietary technology allows us to produce a high yield of adipose-derived vascular stromal cells (haVSC)from only 30-50mL of adipose tissue, thus minimizing pain and recovery time following the lipoaspiration procedure. This is very significant for China, where patients typically do not have a lot of body fat. The haVSCs are further differentiated and expanded to haMPCs with our proprietary cell culture technology.”
About the Therapy
Cellular Biomedicine Group’s therapy for KOA is an interventional therapy that consists of 30-50mL of adipose tissue obtained via lipoaspiration from the patient, from which the patient’s haMPCs are then expanded using CBMG’s proprietary technology. After three weeks there is an initial injection into the knee joints and a second injection three weeks later.
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of certain degenerative diseases and cancers. Our developmental stem cell, progenitor cell, and immune cell projects are the result of research and development by scientists and doctors from China and the United States. Our flagship GMP facility, consisting of eight independent cell production lines, is designed, certified and managed according to U.S. standards. To learn more about CBMG, please visit: www.cellbiomedgroup.com
Statements in this press release relating to plans, strategies, trends, specific activities or investments, and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include, but are not limited to, risk factors inherent in doing business. Forward-looking statements may be identified by terms such as "may," "will," "expects," "plans," "intends," "estimates," "potential," or "continue," or similar terms or the negative of these terms. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law.
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