Cellular Biomedicine Group Initiates Patient Recruitment for Cartilage Damage Stem Cell Therapy Clinical Research Study
January 06 2015 - 8:00AM
Cellular Biomedicine Group Inc. (Nasdaq:CBMG) ("CBMG" or the
"Company"), a biomedicine firm engaged in the development of
effective treatments for degenerative and cancerous diseases, today
announced the initiation of patient recruitment to support a study
of ReJoinTM 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 ReJoinTM on CD.
The decision to explore the efficacy of the Company's
proprietary ReJoinTM 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 (see press release here). "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.
About the Study
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 ReJoinTM
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.
About CD in China
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.
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.
CONTACT: Sarah Kelly
Director of Corporate Communications, CBMG
+1 650 566-5064
sarah.kelly@cellbiomedgroup.com
Vivian Chen
Managing Director Investor Relations, Grayling
+1 646 284-9427
vivian.chen@grayling.com
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