Navigation Links
Harvest Technologies Announces Interim Study Results From Critical Limb Ischemia Trial in Chennai India

PLYMOUTH, Mass., April 1 /PRNewswire/ -- Harvest Technologies Corp. ( announced today that the interim study report was completed for the first thirty (30) patients in the clinical trial of patients suffering with non-reconstructable critical limb ischemia due to advanced thromboangitis obliterans, commonly referred to as Buerger's Disease.

The trial is being conducted at Sri Ramachandra University in Chennai India and is designed to evaluate the therapeutic effect of a composition of nucleated bone marrow cells prepared using the Harvest SmartPReP System. The study is being led by principal investigator Prof. K. S. Vijayraghavan, Head of Vascular Surgery. Harvest's SmartPReP System is a point-of-care device for concentrating a patient's own (autologous) bone marrow stem cells in approximately 15 minutes.

Prof. Vijayraghavan stated, "This study has very important implications for treating this patient population, because they are young (average age 45) and have limited access to any revascularization options. The trial was the first of its kind to be approved by all regulatory bodies in India," and was conducted in accordance with the significant risk provision of the Investigational Device Exemptions Regulations (21 CFR Part 812); the Protection of Human Subjects Regulations, including Subpart B Informed Consent of Human Subjects (21 CFR Part50); the Institutional Review Board Regulations (21 CFR Part 56).

Patients enrolled in the trial were treated with a composition of concentrated bone marrow nucleated cells, termed BMAC. A total of 240 mL of marrow aspirate was processed using the point of care SmartPReP System (Harvest Technologies, Plymouth, MA) to yield 40 mL of treating volume. The patients were divided equally into two treatment groups. Group 1 received forty (40) 1 mL intramuscular injections in the ischemic regions below the knee and Group 2 received twenty (20) 1 mL intramuscular injections below the knee and an intra-arterial infusion of 20 mL down the open SFA into the lower leg.

The interim evaluation of these patients conducted at 12 weeks showed convincing evidence that the treatment had significant clinical effect. The most important finding was that 87.5% of patients were able to save their legs. Other major endpoints also showed significance improvement. Quality of Life assessment (Rand-36 questionnaire) and individual perception of pain showed statistically significant improvement (p=0.0009 and 0.0001 respectively). There was 100% reduction in the use of pain medications. Limb perfusion, as measured by TcPO2 and ABI also showed statistically significant improvement (p=0.0001 and 0.0003 respectively). 33% of the patients had serious ulcers and 90% of these showed 90% or better wound closure in 26 weeks. There were no adverse events associated with the treatment. Harvest and its agent in India are hopeful that this data along with data generated in Europe will aid in obtaining the necessary clearances for the marketing the Harvest BMAC System for the treatment of CLI in India before the end of this calendar year.

Published studies in this area have used complicated methods to process and concentrate adult stem cells from a patient's bone marrow. The SmartPrep System is the first to offer clinicians a simple, easy point-of-care method to prepare a concentration of stem and precursor cells from a small aspirate of autologous bone marrow in just 15 minutes. 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.

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., Harvest Technologies is sponsoring a multi-centered randomized controlled double-blind study evaluating the therapeutic effect of BMAC for treating patients with non-reconstructable CLI.

Harvest Technologies is a privately held company based in Plymouth, Mass.

    P. Kevin Benoit, VP/General Manager, Strategic Business Development:

SOURCE Harvest Technologies Corp.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. StemCor Systems Receives FDA Clearance for Bone Marrow Harvesting System
2. Osteotech Signs Agreement To Distribute Harvest Technologies BMAC(TM) System
3. Quaker Introduces Simple Harvest(TM) All Natural Multigrain Chewy Granola Bars That Taste Simply Delicious
4. CalbaTech Announces $999,926 Reduction in Debt; First Adult Stem Cell Harvesting Scheduled
5. American Red Cross Honors Americas Second Harvest at Heritage of Service Dinner
6. New Technique Harvests Stem Cells at Earlier Stage
7. Fresh Harvest Products, Inc. Announces New Brand Initiative
8. Americas Second Harvest Provides Emergency Food and Water to Tropic Storm Fay Evacuees
9. MAQUET Cardiovascular Responds to Terumo Complaint About VASOVIEW Endoscopic Vessel Harvesting Systems
10. 2008 Idaho Potato Harvest Forecast: Plentiful, High-Quality Spuds
11. Harvest Technologies Announces Patient Education Website, : Supports first randomized, placebo-controlled clinical trial in the U.S. using autologous adult stem cells to treat patients with end-stage Critical Limb Ischemia
Post Your Comments:
(Date:11/27/2015)... , ... November 27, 2015 , ... CBD College ... of Allied Health Education Programs (CAAHEP) awarded accreditation to its Diagnostic Medical Sonography program. ... accredited colleges, as only one of twelve colleges and universities in the state of ...
(Date:11/27/2015)... ... November 27, 2015 , ... Avid collector, Andrew Hawley from Vintage Rock Posters, ... posters. This is one of Joplin's most famous and beautiful concert posters. The concert ... Michigan in Ann Arbor. The According to Hawley, "It is hard to believe that ...
(Date:11/26/2015)... ... 26, 2015 , ... Inevitably when people think Thanksgiving, they also think Holiday ... the Black Friday and Cyber Monday massage chair sales to receive the ... and low to find the best massage chair deals, they can see all of ...
(Date:11/26/2015)... ... November 26, 2015 , ... ... to discuss bioavailability and the need to integrate dose form selection in early ... with OBN, the membership organization supporting and bringing together the UK’s emerging life ...
(Date:11/26/2015)... ... November 26, 2015 , ... WorldCare International, Inc., the ... 61st annual Employee Benefits Conference. The Employee Benefits Conference was hosted by the ... Wednesday, November 11th, 2015. The conference was held at the Hawaii Convention Center ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... THOUSAND OAKS, Calif. , Nov. 25, 2015 /PRNewswire/ ... of a Biologics License Application (BLA) with ... Administration (FDA) for ABP 501, a biosimilar candidate to ... the first adalimumab biosimilar application submitted to the FDA ... biosimilar pathway. Sean E. Harper , M.D., ...
(Date:11/25/2015)... AAIPharma Services Corp./Cambridge Major Laboratories, Inc. ... $15.8  Million to expand its laboratories and global ... The expansion will provide additional office space and ... of the pharmaceutical and biotechnology markets. ... up to 40,000 square feet of expanded development ...
(Date:11/25/2015)... Nov. 25, 2015  Henry Schein, Inc., the world,s ... office-based dental, medical and animal health practitioners, will unveil ... Henry Schein ConnectDental® Pavilion , which brings together ... open solutions designed to help any practice or laboratory ... for a schedule of experts appearing at the ...
Breaking Medicine Technology: