Cellular Biomedicine Group Releases Positive Six-Month Data From Phase I/IIa Clinical Trial for ReJoin(TM) Treatment of Knee ...
June 19 2014 - 8:30AM
Cellular Biomedicine Group, Inc. (Nasdaq:CBMG) today released the
six-month follow-up data analysis of its Phase I/IIa clinical trial
for its Rejoin™ human adipose-derived mesenchymal precursor cell
(haMPC) therapy for Knee Osteoarthritis (KOA). The trial, conducted
by Shanghai Renji Hospital, tested the safety and efficacy of
intra-articular injections of autologous haMPCs in order to reduce
inflammation and repair damaged joint cartilage.
The primary endpoints for this trial were safety and
knee-related pain, stiffness and function measured using the
Western Ontario and McMaster Universities (WOMAC) osteoarthritis
index questionnaire. The secondary endpoints were cartilage repair
at six months, defined through the volume of the repair tissue
measured with quantitative magnetic resonance imaging (MRI) as well
as NRS-11, SF-36 and KSCRS scores.
With the last patient treated in Q4 2013, analysis of the full
six-month follow-up data has revealed:
- MRI Quantitative Assessment: Increase in
cartilage volume of whole joint as early as three months after the
therapy, and confirmed average of 53.07mm3 six months after the
therapy. Reduction of bone marrow lesions in some patients.
- Western Ontario and McMaster Universities Arthritis
Index (WOMAC): Decreased by 14.69 from
the baseline (P<0.01); improved knee mobility
- Numeric Rating Scale for Pain (NRS-11):
Decreased by 2.35 from the baseline (P<0.01); significantly
reduced knee pain
- Short Form Health Survey (SF-36): Decreased by
4.69 from the baseline (P>0.05)
- Knee Society Clinical Rating System (KSCRS):
Increased by 29.38 from the baseline (P<0.01); prolonged walking
distance
- No serious adverse events (SAE)
"We are very excited that the data from this trial has surpassed
our expectations. Patients have reported a significant improvement
in mobility, flexibility and a decrease in pain, while the clinical
data shows ReJoinTM therapy to be both safe and effective. We look
forward to reviewing the 12-month follow-up data in Q4 of this
year," commented Wei (William) Cao, PhD, BM, Chief Executive
Officer of Cellular Biomedicine Group, Inc. "The opportunity for
patients to regenerate their damaged knee cartilage using their own
stem cells, could be much more preferable to undergoing painful,
invasive knee replacement surgery or other invasive surgery
procedures. In addition to the potential to improve quality of life
for many patients, the positive results from the ReJoinTM trial
represent a rapid pathway for us to begin commercializing this
therapy in China, in what we believe is the largest KOA market in
the world."
Knee Osteoarthritis in China
According to International Journal of Rheumatic Diseases, 2011
there are approximately 57 million people in China suffering from
knee osteoarthritis. Drug-based methods of management to date are
ineffective, the quality of life of patients with KOA is
compromised, and many KOA patients will degenerate to the point of
requiring invasive artificial joint replacement surgery. According
to Epidemiology of Rheumatic Disease (Silman AJ, Hochberg MC.
Oxford Univ. Press, 1993:257) 53% of KOA patients will eventually
become disabled.
About ReJoinTM Therapy
Cellular Biomedicine Group's ReJoinTM therapy for KOA is an
interventional therapy that consists of 30ml of adipose (fat)
tissue obtained via lipoaspiration from the patient, from which the
patient's vascular stromal cells (VSC; a combination of several
types of monocytes including mesenchymal stem cells) are isolated
using CBMG's proprietary medical device, the A-Stromal Kit, which
produces a high yield of VSC, and haMPCs are then expanded using
CBMG's proprietary culture medium. After three weeks there is an
initial injection into the knee joints and a second injection three
weeks later.
Some of the special characteristics of ReJoinTM Therapy are:
- Autologous – patient's own cells
- Readily available, easy to source via minimally invasive
lipoaspirate
- Unlimited supply of own cells from one lipoaspirate
- No immune rejection
- High concentration of stem cells - only 30ml of adipose (fat)
tissue required
- Shortest time to profound results, including cartilage
regrowth
- Quick recovery relatively compared to knee replacement
surgery
- Long term therapeutic effects
- No severe side effects
Cellular Biomedicine Group is currently running a multi-center
Phase IIb clinical trial for ReJoinTM, which further studies the
efficacy of CBMG's proprietary haMPC-based therapy for KOA.
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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