Cellular Biomedicine Group, Inc. (otcqb:CBMG) today announced updated analysis 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 haMPCs in order to reduce inflammation and repair damaged joint cartilage. Completed in Q4 2013, the data shows no serious adverse events (SAE), suggesting ReJoin cell therapy for KOA patients is safe.
Three-month follow up data reveals statistically significant improvement in KOA from the baseline in clinical scores for WOMAC, NRS-11, SF-36, and KSCRS knee osteoarthritis indices, showing significantly reduced knee pain, improved knee mobility, and prolonged walking distance. Reduction of bone marrow lesions was observed in some patients. MRI examination revealed an increase in cartilage thickness as early as three months after the therapy.
Data of three patients who have completed six-month follow-up has confirmed the three-month findings, and full analysis of the six-month follow-up for all patients in the trial is still ongoing. Additional studies are being carried out to confirm the cartilage regrowth.
Presenting these results at the New York Stem Cell Summit on February 18, 2014, Wei (William) Cao, PhD, BM, Chief Executive Officer of Cellular Biomedicine Group, Inc. said, “We are very excited with the preliminary analysis of the trial. As far as we know this may be the first evidence that adipose derived stem cells can regenerate human cartilage in three months. Our preliminary conclusion from the three-month follow-up of the Phase I/IIa clinical trial is that ReJointherapy is both safe and effective. We are expecting the on-going Phase IIb study will provide more data to show the advantages of ReJoin cell therapy for KOA.”
Knee Osteoarthritis in China
There are approximately 57 million people in China suffering from knee osteoarthritis. As drug-based methods of management are ineffective, life quality of KOA patients is compromised, and 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. The trial is conducted by Shanghai’s Renji Hospital, a tertiary hospital affiliated with Shanghai Jiao Tong University School of Medicine.
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
Forward-Looking Statements
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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