PALO ALTO, CA, USA I August 12, 2014 I Cellular Biomedicine Group Inc. (CBMG) (the “Company”) today announced that it has treated the final patient in its Phase IIb trial to further evaluate the safety and efficacy of their proprietary adipose-derived mesenchymal precursor cell (haMPC)-based therapy ReJoinTM for Knee Osteoarthritis (KOA).
Dr. William (Wei) Cao, Chief Executive Officer of the Company, commented, “The patient enrollment and treatment were carried out smoothly and completed earlier than anticipated. There have been no Severe Adverse Events (SAE) observed to date. We are very pleased with the progress of ReJoinTM therapy Phase IIb trial. The excellent readout from the six-month follow-up of the Phase I/IIa trial makes us optimistic about the results of the Phase IIb trial, which will be announced in the first quarter of 2015.” A Phase I/IIa twelve-month follow-up MRI readout has been completed and we expect the official report to be available by early fourth quarter of 2014.
Full data analysis will be carried out by FuDan Medical University Department of Biostatistics, one of the most authoritative biostatistics institutions in China.
The Phase I/IIa clinical trial for this therapy was completed in the fourth quarter of 2013, with the six-month follow-up data analysis concluding that ReJoinTM cell therapy for KOA patients is safe and revealing an increase in cartilage volume as early as three months after the therapy. (click here to view detailed six-month data).
About the Clinical Trial
The Phase IIb clinical research trial for KOA, registered with the U.S. National Institutes of Health (NIH) under the number NCT02162693 (click here to view), is led by Shanghai Renji Hospital, one of the largest teaching hospitals in China. The multi-center study enrolled 53 patients to participate in a randomized, single-blind trial.
The primary endpoints for this trial are knee-related pain, stiffness and function as measured using the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index questionnaire. The secondary endpoints are cartilage repair at six months by assessment of changes of the knee joint cartilage’s volume measured with quantitative magnetic resonance imaging (MRI), in addition to NRS-11, SF-36 and KSCRS scores, and the recording of any moderate to serious adverse events.
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.
SOURCE: Cellular Biomedicine
Post Views: 46
PALO ALTO, CA, USA I August 12, 2014 I Cellular Biomedicine Group Inc. (CBMG) (the “Company”) today announced that it has treated the final patient in its Phase IIb trial to further evaluate the safety and efficacy of their proprietary adipose-derived mesenchymal precursor cell (haMPC)-based therapy ReJoinTM for Knee Osteoarthritis (KOA).
Dr. William (Wei) Cao, Chief Executive Officer of the Company, commented, “The patient enrollment and treatment were carried out smoothly and completed earlier than anticipated. There have been no Severe Adverse Events (SAE) observed to date. We are very pleased with the progress of ReJoinTM therapy Phase IIb trial. The excellent readout from the six-month follow-up of the Phase I/IIa trial makes us optimistic about the results of the Phase IIb trial, which will be announced in the first quarter of 2015.” A Phase I/IIa twelve-month follow-up MRI readout has been completed and we expect the official report to be available by early fourth quarter of 2014.
Full data analysis will be carried out by FuDan Medical University Department of Biostatistics, one of the most authoritative biostatistics institutions in China.
The Phase I/IIa clinical trial for this therapy was completed in the fourth quarter of 2013, with the six-month follow-up data analysis concluding that ReJoinTM cell therapy for KOA patients is safe and revealing an increase in cartilage volume as early as three months after the therapy. (click here to view detailed six-month data).
About the Clinical Trial
The Phase IIb clinical research trial for KOA, registered with the U.S. National Institutes of Health (NIH) under the number NCT02162693 (click here to view), is led by Shanghai Renji Hospital, one of the largest teaching hospitals in China. The multi-center study enrolled 53 patients to participate in a randomized, single-blind trial.
The primary endpoints for this trial are knee-related pain, stiffness and function as measured using the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index questionnaire. The secondary endpoints are cartilage repair at six months by assessment of changes of the knee joint cartilage’s volume measured with quantitative magnetic resonance imaging (MRI), in addition to NRS-11, SF-36 and KSCRS scores, and the recording of any moderate to serious adverse events.
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.
SOURCE: Cellular Biomedicine
Post Views: 46
