Navigation Links
Harvest Technologies Announces Trial Results in its India Study Using BMAC to Treat Patients With Non-Reconstructable Critical Limb Ischemia

PLYMOUTH, Mass., Dec. 1 /PRNewswire/ -- Harvest Technologies Corp. ( announced today results from the company sponsored 60-patient clinical trial conducted at Sri Ramachandra Medical Center in Chennai, India using the company's BMAC System to treat patients with non-reconstructable Critical Limb Ischemia (CLI). Sri Ramachandra Medical Center is a Harvard Medical international-associated institution based in Chennai, India and one of the largest private healthcare facilities in South Asia. The study was directed by Prof. K. S. Vijayaragavan, Chief of Vascular Surgery at Sri Ramachandra University and met all regulatory approvals imposed by the Drug Controller of India and the Ethics Committee of Sri Ramachandra University, Chennai, India.

Critical limb ischemia is a persistent and relentless problem, which severely impairs the patient functional status and quality of life, and is associated with an increased cardiovascular mortality and morbidity. Prognosis of critical limb ischemia is poor and no effective treatments have been established in patients who are not amenable for the traditional revascularization therapies such as angioplasty and bypass procedures. Hence these patients have no option other than undergoing amputation or limb loss. In India a significant percentage of the patients with peripheral vascular disease are between the age of 40 to 50. They suffer from Thrombo Angitis Obliterans, which is predominant in young smokers. They have severe pain, open non-healing wounds and limb loss since revascularization chances are very low in these patients. Most end up with major amputation, resulting in the inability to work.

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, which enrolled the largest number of subjects of any study to date, utilized the BMAC system to process bone marrow aspirated from the patient in order to produce a highly concentrated composition of multipotent nucleated cells. The BMAC system is unique in that it can produce this cellular composition in 15 minutes within the operating room. A unique feature of the trial was to compare the relative effectiveness of two different delivery methods. Thirty of the subjects received the BMAC composition by injection and thirty received the same amount of BMAC but half of the volume by injection and the remaining half by infusion into a major artery.

The data from the 60 subjects was analyzed by an independent Contract Research Organization (Ecron Acunova, Bangalore, INDIA). The Ecron Acunova report showed that weeks 12 post treatment amputation free survival for the treated population was 90%. In addition, there was a statistically significant reduction in the subject's pain perception, increase in pain free walking distance, maximum walking distance, various perfusion measures including Regional Perfusion Index, as well as a significant improvement in the Quality of Life assessment (RAND-36 scores).

Another significant outcome, not shown in other studies, was the effect of the Harvest cell composition on the severity of the disease. CLI is a progressively degenerative disease with increasing serious in the disease being categorized by a classification system known as the Rutherford system; Rutherford classification progresses from 1 (least serious) to 6 (most serious with limb amputation imminent). All the 60 study patients were classified as either Rutherford class 4 or 5 (78% were class 5) and 12 weeks after treatment the treated cohort showed a mean reduction of one Rutherford class. "This is a truly extraordinary result," said Prof. Vijayaraghaven, "and if sustained through the end of the study will offer a significant treatment option to a patient population that has had little hope to avoid amputation."

"We are particularly pleased that the results of this study continue to show very promising results," said Gary D. Tureski, President of Harvest Technologies. "When combined with our on going multi-center FDA study in the U.S., and other studies in Germany and the Czech Republic, this study demonstrates 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.

SOURCE Harvest Technologies Corp.

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

Related biology technology :

1. Harvest Technologies Announces Completion of Patient Enrollment in its Randomized, Controlled, Double Blind Multicenter IDE Non-Reconstructable Critical Limb Ischemia Trial
2. UK scientists developing intelligent harvesting robot to save farms up to 100,000 a year
3. 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
4. Scientists determine the structure of highly efficient light-harvesting molecules in green bacteria
5. Mach One Corporation Completes Acquisition of Ceres Organic Harvest, Inc.
6. Mach One Corporation Signs Definitive Agreement to Acquire Ceres Organic Harvest, Inc.
7. BASF Podcast - Better Harvest in Spite of Climate Stress
8. Carrington and Universal Harvest Sign Supply Agreement
9. Fiber-based nanotechnology in clothing could harvest energy from physical movement
10. Nanowire generates power by harvesting energy from the environment
11. Palatin Technologies, Inc. Issued U.S. Patent for Heart Failure Drug Candidate
Post Your Comments:
(Date:11/24/2015)... Nov. 24, 2015 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: ... on behalf of the Toronto Stock Exchange, confirms that ... are no corporate developments that would cause the recent ... --> --> About Aeterna Zentaris Inc. ... --> Aeterna Zentaris is a specialty biopharmaceutical ...
(Date:11/24/2015)... ... 24, 2015 , ... This fall, global software solutions leader SAP and AdVenture ... develop and pitch their BIG ideas to improve health and wellness in their schools. ... to win the title of SAP's Teen Innovator, an all-expenses paid trip to Super ...
(Date:11/24/2015)... November 24, 2015 --> ... research report released by Transparency Market Research, the global ... a CAGR of 17.5% during the period between 2014 ... - Global Industry Analysis, Size, Volume, Share, Growth, Trends ... prenatal testing market to reach a valuation of US$2.38 ...
(Date:11/24/2015)... 2015  Twist Bioscience, a company focused on ... Twist Bioscience chief executive officer, will present at ... 1, 2015 at 3:10 p.m. Eastern Time at The Lotte ... --> --> About ... is on Twitter. Sign up to follow our ...
Breaking Biology Technology:
(Date:10/26/2015)... LAS VEGAS , Oct. 26, 2015 /PRNewswire/ ... innovator in modern authentication and a founding member of ... of its latest version of the Nok Nok™ S3 ... use standards-based authentication that supports existing and emerging methods ... is ideal for organizations deploying customer-facing applications that require ...
(Date:10/23/2015)... Oct. 23, 2015 Research and Markets ( ... "Global Voice Recognition Biometrics Market 2015-2019" report to ... --> The global voice recognition biometrics market to ... --> --> The ... prepared based on an in-depth market analysis with inputs ...
(Date:10/22/2015)... (NASDAQ: AWRE ), a leading supplier of biometrics software and ... 30, 2015.  --> --> ... decrease of 33% compared to $6.0 million in the same quarter ... $2.2 million, or $0.10 per diluted share, which compared to $2.6 ... year ago.  --> --> ...
Breaking Biology News(10 mins):