Cellular Biomedicine Group Completes Enrollment in Phase IIb Clinical Trial for ReJoin(TM) Therapy for Knee Osteoarthritis
26 June 2014 - 10:15PM
Cellular Biomedicine Group Inc. (Nasdaq:CBMG) (the "Company") today
announced that it has completed the patient enrollment required for
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).
"We are pleased to reach this Company milestone and exceed
enrollment of the forty-eight patients required for our Phase IIb
clinical trial for Knee Osteoarthritis," said Dr. Cheng Xiang
(Chase) Dai, VP and GM of Autologous Products Business Unit.
The Phase I/IIa clinical trial for this therapy was completed in
Q4 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 has 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
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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