Navigation Links
Harvest Technologies Announces Completion of Patient Enrollment in its Randomized, Controlled, Double Blind Multicenter IDE Non-Reconstructable Critical Limb Ischemia Trial
Date:11/9/2009

PLYMOUTH, Mass., Nov. 9 /PRNewswire/ -- Harvest Technologies Corp. (www.harvesttech.com) announced today that the company sponsored 48-patient IDE clinical trial conducted at seven sites in the U.S. and one site in India using the company's Bone Marrow Aspiration Concentrate (BMAC) System to treat patients with non-reconstructable Critical Limb Ischemia (CLI) has completed enrollment. Mark D. Iafrati, M.D. Chief of Vascular Surgery at Tufts Medical Center in Boston, directed the study. "This study was unique in the high quality of the clinical investigators with each site being a center of excellence. Thus these patients deemed to have no conventional reconstruction possibility had truly exhausted current options. The BMAC procedure is easier to perform, quicker, less expensive, and less traumatic to our patients than most current treatments. If the results of this feasibility study demonstrate tangible benefits, this could herald a tremendous advance in how we treat patients with peripheral vascular disease." The study design calls for preliminary data analysis after the last subject has completed the 12-week follow-up visit. The company anticipates that these results should be available by the end of February.

Critical limb ischemia is a persistent and relentless disease, which severely impairs patients' functional status and quality of life, and is associated with an increased cardiovascular mortality and morbidity. The prognosis of critical limb ischemia is poor. Even when patients are candidates for current revascularization therapies such as angioplasty or bypass surgery, these therapies are commonly accompanied by significant morbidity and mortality risk. When patients are not candidates for conventional therapies as was the case in the patients enrolled in this clinical trial, the outcomes are uniformly poor. These patients are afflicted with intractable pain and a very high risk of limb loss and/or death.

Autologous cell therapy has been studied as an innovative treatment option for CLI, however; previously published studies did not use a rapid, point of care method for processing the cells therefore making widespread adoption of the therapy problematic. The Harvest trial utilized the BMAC system, which processes the cells in 15 minutes in the operating room. A unique feature of the trial was that it compared the relative effectiveness of the BMAC to a control injection of a placebo. Neither the trial subjects nor the investigators know which material was being injected. Thirty-two of the subjects received the BMAC composition by injection and sixteen received the placebo injection.

In July Harvest announced the completion of enrollment in another trial treating sixty subjects in India suffering from a form of critical limb ischemia referred to as Thromboangitis Obliterans. The 12-week follow up results showed an amputation rate of only 10% and statistically significant improvement in reduction of pain, in perfusion measures, and in quality of life.

"We are particularly pleased that this study is now fully enrolled and by the very promising results shown with the Indian data analysis," said Gary D. Tureski, President of Harvest Technologies. "When combined with our other studies in Germany and the Czech Republic, this study should provide one more step in demonstrating the potential for Harvest's BMAC System to be an effective treatment for Chronic Limb Ischemia regardless of the underlying cause."

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

    Contact:
    P. Kevin Benoit; VP / General Manager Strategic Business Development
     - 508-732-7500

SOURCE Harvest Technologies Corp.


'/>"/>
SOURCE Harvest Technologies Corp.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. UK scientists developing intelligent harvesting robot to save farms up to 100,000 a year
2. Harvest Technologies Announces Completion of Patient Enrollment in its 60 Patient Clinical Trial in India Using Autologous Adult Stem Cells to Treat Patients With Non-Reconstructable Critical Limb Ischemia
3. Scientists determine the structure of highly efficient light-harvesting molecules in green bacteria
4. Mach One Corporation Completes Acquisition of Ceres Organic Harvest, Inc.
5. Mach One Corporation Signs Definitive Agreement to Acquire Ceres Organic Harvest, Inc.
6. BASF Podcast - Better Harvest in Spite of Climate Stress
7. Carrington and Universal Harvest Sign Supply Agreement
8. Fiber-based nanotechnology in clothing could harvest energy from physical movement
9. Nanowire generates power by harvesting energy from the environment
10. Reissue with Tables: BioSpecifics Technologies Corp. Reports Third Quarter 2009 Financial Results
11. Myriant Technologies LLC, Uhde Corporation of America and Uhde GmbH Announce Alliance for Engineering, Procurement & Construction of World Scale Renewable Succinic Acid Plants
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... ... May 25, 2016 , ... Founder of ... board-certified in surgery and surgery of the hand by the National Board of ... to going above and beyond in his pursuit of providing the most comprehensive, ...
(Date:5/25/2016)... ... May 25, 2016 , ... Biohaven ... Administration (FDA) has granted the company’s orphan drug designation request covering BHV-4157 for ... designation granted by the FDA. , Spinocerebellar ataxia is a rare, debilitating ...
(Date:5/23/2016)... ... 2016 , ... The need for blood donations in South Texas and across the nation is ... & Tissue Center, blood donations are on the decline. In fact, donations across the country ... percent in South Texas in the last four years alone. , There is no substitute ...
(Date:5/23/2016)... ... May 23, 2016 , ... RoviSys, a ... based in Aurora, Ohio, has broken ground on a new building in Holly ... Park area, this new location solidifies a commitment to business in the region. ...
Breaking Biology Technology:
(Date:3/21/2016)... March 22, 2016 Unique ... passcodes for superior security   ... provider of secure digital communications services, today announced it ... and offer enterprise customers, particularly those in the Financial ... and voice authentication within a mobile app, alongside, and ...
(Date:3/14/2016)... , March 14, 2016 NXTD ) ... mobile commerce market, announces the airing of a new series ... the week of March 21 st .  The commercials will ... its popular Squawk on the Street show. --> ... the growing mobile commerce market, announces the airing of a ...
(Date:3/10/2016)... , March 10, 2016   Unisys Corporation (NYSE: ... Border Protection (CBP) is testing its biometric identity solution ... Diego to help identify certain non-U.S. citizens leaving ... The test, designed to help determine the efficiency and accuracy ... in February and will run until May 2016. --> ...
Breaking Biology News(10 mins):