Harvest Technologies Corp. (www.harvesttech.com) announced today that a 60-patient clinical trial using the Company's BMAC(TM) System to treat patients with non-reconstructible Critical Limb Ischemia (CLI) is now underway at Shri Ramachandra Medical Center, a Harvard Medical international-associated institution based in Chennai, India, one of the largest private healthcare facilities in South Asia. The study is being led by principal investigator Prof. K. S. Vijayaragavan, Head of Vascular Surgery at Sri Ramachandra University. Harvest's BMAC System is a point-of-care device for concentrating a patient's own (autologous) bone marrow stem cells in approximately 15 minutes.
PLYMOUTH, Mass. (Business Wire EON) February 25, 2008 --
Harvest
Technologies Corp. (www.harvesttech.com)
announced today that a 60-patient clinical trial using the Company’s
BMAC™
System to treat patients with non-reconstructible Critical Limb
Ischemia (CLI) is now underway at Shri Ramachandra Medical Center, a
Harvard Medical international-associated institution based in Chennai,
India, one of the largest private healthcare facilities in South Asia.
The study is being led by principal investigator Prof. K. S.
Vijayaragavan, Head of Vascular Surgery at Sri Ramachandra
University. Harvest’s BMAC System is a
point-of-care device for concentrating a patient’s
own (autologous) bone marrow stem cells in approximately 15 minutes.
This study is designed to treat patients suffering from advanced
thromboangitis obliterans, commonly referred to as Buerger’s
Disease. This condition is prevalent in India and is caused by smoking,
which progressively reduces blood flow to the leg. The initial symptoms
are pain in the leg below the knee which, over time, degenerates to a
point that the patient may no longer be able to walk. While the
underlying cause of Buerger’s Disease is
different from Peripheral Arterial Occlusive Disease (PAOD) caused by
atherosclerosis, which is prevalent in the United States, the treatment
for advanced stages of both conditions is bypass surgery or angioplasty.
The condition of patients who are being enrolled in this study is so
severe that they have exhausted all surgical or endovascular options
available and are facing amputation of the affected limb.
Autologous cell therapy has been studied as an innovative treatment
option for both cardiac and vascular disease, and based on these
studies, it is anticipated that the delivery of a composition of
autologous bone marrow cells to the affected limbs of these patients
will reduce the possibility of amputation and improve their symptoms.
Two small clinical trials have been published that treated these “no
option” Buerger’s
patients with autologous bone marrow cells to treat this patient
population. It also is unique in that it compares the relative
effectiveness of two different delivery methods. Thirty (30) of the
subjects will receive the BMAC composition by injection and thirty (30)
will receive the same amount of BMAC but half of the volume by injection
and the remaining half by infusion into a major artery.
“We have been very impressed with how easy it
has been to harvest, process and deliver these cells all in the same
procedure, and the early clinical results have looked extremely
promising,” said Prof. K. S. Vijayaragavan.
“We are particularly excited to participate
in this study,” said Gary
Tureski, President of Harvest Technologies. “When
this study’s data are combined with data from
our ongoing multi-center FDA study in the U.S., these results will offer
us the opportunity to demonstrate the potential for BMAC to be an
effective treatment for Critical Limb Ischemia regardless of the
underlying cause.”
Until now, it has been difficult to process and concentrate a
clinically significant dose of adult stem cells from a patient’s
bone marrow at the point of care. The BMAC System is the world’s
first and only technique that produces clinically significant amounts of
stem and precursor cells from a small aspirate of autologous bone marrow
in just 15 minutes. In Harvest’s European
studies, injected autologous adult stem cell concentrates from bone
marrow have shown promise in achieving tissue regeneration in vascular,
orthopedic and cardiovascular disease. In the U.S., the BMAC System is
currently marketed for use in “...the
clinical laboratory or intraoperatively at point-of-care for the safe
and rapid preparation of...a cell concentrate from bone marrow.”
Harvest
Technologies is a privately held company based in Plymouth, Mass.
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