Cellular Biomedicine begins patient recruitment for cartilage damage stem cell therapy clinical research study

Posted: January 9, 2015 at 6:42 am

Published 07 January 2015

Cellular Biomedicine Group, a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, announced the initiation of patient recruitment to support a study of ReJoin human adipose derived mesenchymal progenitor cell (haMPC) therapy for Cartilage Damage (CD) resulting from osteoarthritis (OA) or sports injury.

The study is based on the same science that has shown tremendous progress in the treatment of Knee Osteoarthritis (KOA). Both arthroscopy and the use of magnetic resonance imaging (MRI) will be deployed to further demonstrate the regenerative efficacy of ReJoin on CD.

The decision to explore the efficacy of the company's proprietary ReJoin therapy on an additional orthopedic indication, Cartilage Damage (CD), follows the encouraging data readout from its Knee Osteoarthritis Phase IIa Clinical Trial, of which the twelve-month follow-up results were announced in December 2014.

"We anticipate patient treatment in this study to be completed by the end of Q2 2015, and to report the interim results in Q3 2015. We very much look forward to finding the promise of ReJoinTM therapy for further indications. The repair of damaged cartilage would fundamentally improve the quality of life for CD patients, allowing for greater mobility, flexibility and less pain," said Dr. William (Wei) Cao, Chief Executive Officer of the Company.

The Phase II clinical study is a single-blind, randomly assigned, controlled clinical research study that will enroll thirty patients with the purpose of evaluating the safety and efficacy of haMPCs combined with lavage, debridement, and/or microfracture under arthroscopy treatment for cartilage damage.

In addition, this study shall serve as a supporting study of ReJoin for the treatment of Knee Osteoarthritis (KOA) so as to bring additional clinical data to the protocol of future KOA trials.

The study is conducted by Shanghai Ninth People's Hospital, a leading teaching hospital affiliated with Shanghai Jiao Tong University School of Medicine. Professor Wang You, Director of the hospital's orthopedics department and Vice Chairperson of the Chinese Knee Society, will lead the study as Principal Investigator.

Currently in China KOA patients number over 57 million. The incidence of cartilage damage in routine knee arthroscopies has been reported to be almost 300,000 per year. (Source: Market analysis of Chinese arthroscopy, published on July 21, 2014 and "Advances in Orthopedics" Volume 2012, Article ID 528423) Similar to KOA, CD is an unmet orthopedic medical need.

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Cellular Biomedicine begins patient recruitment for cartilage damage stem cell therapy clinical research study

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