Navigation Links
UH Case Medical Center launches novel clinical trial using stem cells to prevent amputation
Date:6/18/2013

University Hospitals Case Medical Center clinical researchers have launched an innovative clinical trial, unique in its design, which will evaluate the ability of a patient's own stem cells to prevent leg amputations in end stage peripheral arterial disease (PAD).

Led by Vik Kashyap, MD, Division Chief, Vascular Surgery at University Hospitals Case Medical Center's Harrington Heart & Vascular Institute and Professor of Surgery at Case Western Reserve University School of Medicine, the clinical trial is designed to improve blood flow in legs with blocked arteries by attempting to treat diseased blood vessels. Peripheral arterial disease (PAD) is a common yet serious disease that occurs when extra cholesterol and fat circulating in the blood collects on the walls of the arteries that supply blood to the limbs.

Due to the location and extent of the blockages in certain individuals, standard treatments such as surgical bypass (insertion of a vein or synthetic graft to redirect blood flow around the blockage) and angioplasty (insertion of a balloon through the artery to open the blockage) will not improve blood flow to the leg, and amputation is the only alternative.

For patients with critical limb ischemia (CLI) revascularization procedures such as surgical bypass or percutaneous angioplasty/stenting are currently the only option to restore perfusion and maintain limb viability.

For CLI patients who are non-candidates for revascularization, amputation is often needed. It is estimated that over 160,000 amputations are performed in the United States each year.

The number of CLI patients who will not be candidates for revascularization continues to rise as the population ages and the incidence of diabetes and other vascular risk factors increase. For CLI patients who are considered unreconstructable, the amputation and mortality rates at six months approach 40% and 20%, respectively. Furthermore, nearly 30% of patients who undergo below-knee amputation will fail rehabilitation and require chronic institutional care or professional assistance at home.

The trial sponsor, Biomet Biologics (Warsaw, IN), recently completed a Phase I study of 30 subjects to evaluate the safety of autologous concentrated bone marrow aspirate for critical limb ischemia. The results of this study were used to advance the company's MarrowStim concentration technology into the FDA-approved, pivotal IDE trial described here. Overall, the trial will enroll 152 subjects at up to 20 investigational sites.

"This trial offers an opportunity to save a patient's leg when there are no remaining options to improve blood supply," said Dr. Kashyap. "We are pleased to add this capability at UH and provide hope for patients facing the risk of limb loss."

Subjects will be randomized to receive either the investigational treatment involving the MarrowStim P.A.D. Kit (75% chance), or a placebo control involving a sham procedure (25% chance). The trial's primary end point of time to treatment failure, defined as major amputation or death, will be evaluated over a one‐year follow‐up period. Secondary end points, including rest pain, perfusion measurements, quality of life, and safety, will also be evaluated for one year.


'/>"/>

Contact: Mike Ferrari
mike.ferrari@uhhospitals.org
216-844-7239
University Hospitals Case Medical Center
Source:Eurekalert

Related medicine news :

1. Physician Groups Call for Fewer Medical Tests
2. Weill Cornell Medical College establishes Center for Healthcare Informatics and Policy
3. CAM therapy combined with conventional medical care may improve treatment of lower back pain
4. Image share project gives patients and physicians anytime, anywhere access to medical images
5. Researchers determine vitamin D blood level for reducing major medical risks in older adults
6. Biomedical researchers receive Hartwell Foundation awards
7. Columbia University Medical Center and NY-Presbyterian experts at APA meeting
8. Fitness in Middle Age Lowers Medical Costs Later: Study
9. Ben-Gurion U. and Cincinnati Childrens Hospital to develop pediatric-specific medical technologies
10. Gene Tests May Not Drive Patients to More Medical Care
11. University studies and career expectations of medical students
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/22/2017)... ... February 22, 2017 , ... The ... Insights to help small practices in Delaware, New Jersey, Pennsylvania and West Virginia ... Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). , This technical ...
(Date:2/22/2017)... ... February 22, 2017 , ... Forty-five percent of American ... that family members or friends have also commented about their poor hearing. However, ... hearing aids. One reason, suggested by 89 percent of American respondents, is that ...
(Date:2/22/2017)... ... February 22, 2017 , ... FPS is a nonprofit ... , Established in 1977, our organization was at the forefront in working with ... civilian life were evident and served as the catalyst for the establishing the ...
(Date:2/22/2017)... , ... February 22, 2017 , ... ... for supply chain management (SCM) and spend management, today announced that Keppel Corporation ... time, and simplify expense tracking. , “We are excited to announce the ...
(Date:2/21/2017)... ... February 21, 2017 , ... ... senior director at PolicyLink, will be the keynote speaker at its second Professional ... Men of Color Framework, which develops comprehensive strategies to create and expand opportunities ...
Breaking Medicine News(10 mins):
(Date:2/22/2017)... and PUNE, India , February 22, 2017 ... global market was valued at $3,453 million in 2015 and is projected to reach ... The arthroscopic implants segment held nearly two-fifths of the total market in 2015. ... ... Research Logo ...
(Date:2/22/2017)... Feb. 22, 2017   Protein Sciences Corporation , ... Flublok® Influenza Vaccine , announced today that they donated ... Vaccine Introduction (PIVI) and the Mongolian Ministry of Health ... the flu.  The doses of Flublok have been distributed ... for health care workers, pregnant women, and ...
(Date:2/22/2017)... MIAMI , Feb. 22, 2017  Tri-Source Pharma ... restructuring efforts. A series of newly appointed positions were ... founder and CEO, Robert DiCrisci , in the ... plan and management of the recently consolidated subsidiary companies. ... Tri-Source,s executive team will be composed of the following ...
Breaking Medicine Technology: