SHANGHAI, China and CUPERTINO, CA, USA I January 06, 2016 I Cellular Biomedicine Group Inc. (CBMG) (“CBMG” or the “Company”), a biomedicine firm engaged in the development of effective stem cell therapies for degenerative diseases and immunotherapies for cancer, today announced the launch of a Phase I clinical trial of an off-the-shelf allogeneic adipose-derived mesenchymal progenitor cell (haMPC) AlloJoinTM therapy for Knee Osteoarthritis (KOA).
AlloJoinTM therapy is built on the Company’s promising technology platform and clinical experience using autologous adipose-derived mesenchymal progenitor cells (haMPC) ReJoin® therapy for the treatment of KOA. In addition to the safety and efficacy being demonstrated in clinical trials for the autologous ReJoin® therapy, the safety profile of allogeneic stem cell therapies in humans has been documented, and animal model studies conducted by the Company have also provided preliminary evidence of efficacy of allogeneic adipose derived and expanded mesenchymal progenitor cells for treatment of KOA. The development of an allogeneic product seeks to provide additional benefits to patients and physicians in that it generates a bank of third-party donor haMPCs that can be used for off-the-shelf treatment, allowing for ease of manufacture and use, lower costs and a selection of more healthy donors. This could increase the number of patients that can be treated by a single isolation with the same quality manufacturing procedures.
About the Clinical Trial
The study of AlloJoinTM for KOA will be led by Shanghai Renji Hospital, one of the largest teaching hospitals in China, with Principal Investigator ChunDe Bao, MD, Professor of Medicine, Vice Chairman of the Chinese Rheumatology Association. The Institutional Review Board (IRB)-approved study will enroll 18 patients with knee osteoarthritis (Kellgren-Lawrence Grading Scale: grade II-III) to participate in a randomized, double blinded trial. The trial is registered with the U.S. National Institutes of Health (NIH) under the number NCT02641860 (click here to view).
The primary endpoint for this trial is safety after cell therapy. The secondary endpoints are knee-related pain, stiffness and function measured using the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index questionnaire and cartilage repair/regeneration post cell therapy, defined through changes of both knee joints’ cartilage volume measured with 3D spoiled gradient-recalled echo (SPGR) quantitative magnetic resonance imaging (MRI) and read with a semi-automated segmentation method (ITK-SNAP). A number of biomarkers and their changes in response to the therapy will also be studied as exploratory end points.
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of certain degenerative and cancerous diseases. Our developmental stem cell and Immuno-Oncology projects are the result of research and development by scientists and doctors from China and the United States. Our GMP facilities in China, consisting of nine independent cell production lines, are designed, certified and managed according to U.S. standards. To learn more about CBMG, please visit: www.cellbiomedgroup.com.
SOURCE: Cellular Biomedicine
Post Views: 213
SHANGHAI, China and CUPERTINO, CA, USA I January 06, 2016 I Cellular Biomedicine Group Inc. (CBMG) (“CBMG” or the “Company”), a biomedicine firm engaged in the development of effective stem cell therapies for degenerative diseases and immunotherapies for cancer, today announced the launch of a Phase I clinical trial of an off-the-shelf allogeneic adipose-derived mesenchymal progenitor cell (haMPC) AlloJoinTM therapy for Knee Osteoarthritis (KOA).
AlloJoinTM therapy is built on the Company’s promising technology platform and clinical experience using autologous adipose-derived mesenchymal progenitor cells (haMPC) ReJoin® therapy for the treatment of KOA. In addition to the safety and efficacy being demonstrated in clinical trials for the autologous ReJoin® therapy, the safety profile of allogeneic stem cell therapies in humans has been documented, and animal model studies conducted by the Company have also provided preliminary evidence of efficacy of allogeneic adipose derived and expanded mesenchymal progenitor cells for treatment of KOA. The development of an allogeneic product seeks to provide additional benefits to patients and physicians in that it generates a bank of third-party donor haMPCs that can be used for off-the-shelf treatment, allowing for ease of manufacture and use, lower costs and a selection of more healthy donors. This could increase the number of patients that can be treated by a single isolation with the same quality manufacturing procedures.
About the Clinical Trial
The study of AlloJoinTM for KOA will be led by Shanghai Renji Hospital, one of the largest teaching hospitals in China, with Principal Investigator ChunDe Bao, MD, Professor of Medicine, Vice Chairman of the Chinese Rheumatology Association. The Institutional Review Board (IRB)-approved study will enroll 18 patients with knee osteoarthritis (Kellgren-Lawrence Grading Scale: grade II-III) to participate in a randomized, double blinded trial. The trial is registered with the U.S. National Institutes of Health (NIH) under the number NCT02641860 (click here to view).
The primary endpoint for this trial is safety after cell therapy. The secondary endpoints are knee-related pain, stiffness and function measured using the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index questionnaire and cartilage repair/regeneration post cell therapy, defined through changes of both knee joints’ cartilage volume measured with 3D spoiled gradient-recalled echo (SPGR) quantitative magnetic resonance imaging (MRI) and read with a semi-automated segmentation method (ITK-SNAP). A number of biomarkers and their changes in response to the therapy will also be studied as exploratory end points.
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of certain degenerative and cancerous diseases. Our developmental stem cell and Immuno-Oncology projects are the result of research and development by scientists and doctors from China and the United States. Our GMP facilities in China, consisting of nine independent cell production lines, are designed, certified and managed according to U.S. standards. To learn more about CBMG, please visit: www.cellbiomedgroup.com.
SOURCE: Cellular Biomedicine
Post Views: 213
