Early Study Results Show New Stem Cell Treatment Successfully Treats Critical
Limb Ischemia (CLI) Patients
First results of randomized, placebo-controlled, double-blinded study
of CLI; data presented at annual meeting of the German Society of
Cardiology
PLYMOUTH, Mass. (Business Wire EON) May 6, 2008 --
Harvest Technologies Corp. (www.harvesttech.com)
announced today that Claas Lüdermann, MD,
a specialist in vascular medicine, presented preliminary data at the 74th
Annual Meeting of the German Society of Cardiology from a clinical trial
being conducted at the Berlin (Germany) Vascular Center of Franziskus
Hospital under the direction of Berthold Amman, MD. The “BONe
Marrow Outcome Trial-2”
(BONMOT-2) is a randomized, controlled, double-blinded study treating
patients with end-stage peripheral vascular disease (Critical Limb
Ischemia, or CLI), using a cellular composition of autologous
stem cells. This same treatment methodology has shown to be very
promising in international clinical pilot studies, including a
successful pilot study (BONMOT-1) of 60 patients recently completed
under Dr. Amann’s supervision at the Berlin
Vascular Center.
Dr. Ludermann presented results on the first 12 of 90 patients who
completed the BONMOT-2 study protocol—six from
the control group who received a placebo treatment, and
six from the treatment group who received an injection
of a concentrate of their own bone marrow stem cells. The stem
cell concentrate was produced at the point of care (concentrated
at the patients’ bedside) using the Harvest
Technologies BMAC™ System. The
treatment group showed a 100 percent improvement in perfusion (0.3 to
0.62) as measured by the ankle-brachial index (“ABI”)
compared to the control group, which exhibited only a
non-significant change in ABI (0.4 to 0.5). Increased blood supply was
also confirmed by an increase of oxygen pressure in the foot, which
showed the treatment group having an 18-point increase compared to a
seven-point increase in the control group. The treatment group also
showed an improvement in a standardized quality-of-life assessment over
the control group, and also a significant improvement of 30 meters in
pain-free walking compared to an increase of 10 meters for the control
group.
Dr. Lüdemann stated: “It
is encouraging that the early results of the BONMOT-2 study closely
mirror the positive results obtained in our pilot study. We are
optimistic that this favorable trend will continue as more study data is
available.”
(Note: Harvest is supporting additional scientifically stringent CLI
studies in Europe, India and the US to document the effectiveness of its
Harvest BMAC™ System for a treatment option
for this serious disease. In the United States the FDA has granted
Investigational Device Exemption (IDE) approval to Harvest to commence a
48-patient ‘feasibility’
clinical trial in the U.S. using the company’s
BMAC System to treat patients with CLI. The BMAC System is a
point-of-care device for concentrating bone marrow stem cells in
approximately 15 minutes. The study’s design
provides for injecting a patient’s own
concentrated bone marrow containing stem cells into the affected limb to
study the potential for reducing limb amputation. Stem cells induce the
growth of new collateral arteries and improve the quality of life of
these seriously ill CLI patients. The patients who are being enrolled in
this study have exhausted all other surgical options and are at extreme
risk for major amputation. This U.S. clinical study is being led by
Principal Investigator Mark D. Iafrati, M.D., Chief of Vascular
Surgery at Tufts-New England Medical Center, Boston. Seven additional
major university-based medical centers are participating.)
Harvest
Technologies Corp is a
privately held company based in Plymouth, Mass.
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