Navigation Links
Feds give researchers ok for safety test of adult stem cells in patients with heart disease

Researchers at Case Western Reserve University School of Medicine and University Hospitals of Cleveland announced that the Food and Drug Administration (FDA) has approved plans to begin a study to evaluate the safety of using adult stem cells from bone marrow to treat chronic ischemia, a serious form of heart disease.

The FDA has approved a Phase I study designed to test the safety of the procedure. It will involve injecting bone marrow stem cells at varying doses into the coronary arteries of patients suffering chronic ischemic coronary artery disease, a condition in which one or more of the primary arteries supplying blood flow to the heart are clogged. The study will include patients who are not candidates for angioplasty, stent placement or coronary artery bypass grafting (CABG).

Dale Adler, M.D., vice chair of medicine at Case and UHC, will lead this study. The Harvard Clinical Research Institute (HCRI) has been contracted to help run the trial and will establish an independent data and safety monitoring board to ensure patient safety and data integrity.

"This is a first step in a long process to determine if this method can someday be used to help patients with this heart condition," said Adler.

The trial is one of three ongoing studies in the United States to use bone marrow stem cells to treat chronic ischemia. The procedure will include harvesting stem cells from a patient's bone marrow, capturing the stem cells, and then infusing the stem cells through a coronary artery so that new blood vessels will grow (neovasculogenesis). The hope is the new blood vessels will replace or supplement those blood vessels that fail to adequately supply oxygenated blood to heart tissue. The method was developed by Mary Laughlin, M.D., a hematologist, and Vincent Pompili, M.D., a cardiologist, both of Case, UHC and the National Center for Regenerative Medicine which has the mission of bringing stem cell research from the laboratory into development for the treatment of patients.

"Traditionally, physicians have been able to prevent heart attack or alleviate its after-effects, but they have not figured out how to initiate the sort of blood vessel repair that remains a key to survival," says Dr. Laughlin. "Now there is a promise of achieving that repair by infusing highly selected marrow stem cells."

Upon acceptance in the study, patients with blocked or damaged heart vessels will be assigned to one of three groups, each made up of three to four patients who will receive a preset dose of stem cell therapy. They will have stem cells drawn from their own bone marrow. These cells will then be enriched in the laboratory and injected into the patients at the site of their ischemia.

The Phase I study is being conducted at University Hospitals of Cleveland with support from the National Institutes of Health, Case Western Reserve University, and Cleveland-based Arteriocyte.

Blocked or damaged blood vessels are a major cause of illness and death around the world. Atherosclerosis, for example, can lead to congestive heart failure and heart attacks. About 5 million people in the United States have heart failure and the number is growing. Each year, another 550,000 people are diagnosed for the first time. It contributes to or causes about 300,000 deaths each year. About 1 percent of the U.S. population over the age of 65 is diagnosed with congestive heart failure each year. Existing therapies include drugs, gene therapy, and vascular interventions for relief of arterial obstructions.

In 2003, approximately 750,000 coronary artery bypass graft (CABG) surgeries were performed worldwide and approximately 1.8 million balloon angioplasty procedures were performed. While these interventional therapies are now the standard of care, there are still a significant number of people for whom these methods do not work, or who have blockage throughout their bodies.


'"/>

Source:Case Western Reserve University


Related biology news :

1. NYU researchers simulate molecular biological clock
2. Vital step in cellular migration described by UCSD medical researchers
3. ASU researchers finds novel chemistry at work to provide parrots vibrant red colors
4. UCSD researchers maintain stem cells without contaminated animal feeder layers
5. Why do insects stop breathing? To avoid damage from too much oxygen, say researchers
6. New protein discovered by Hebrew University researchers
7. First real-time view of developing neurons reveals surprises, say Stanford researchers
8. Agilent Technologies releases automated literature search tool for biology researchers
9. Self-assembled nano-sized probes allow Penn researchers to see tumors through flesh and skin
10. Yale researchers identify molecule for detecting parasitic infection in humans
11. US life expectancy about to decline, researchers say
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:1/21/2017)... , Jan 20, 2017 Research and Markets ... Market 2017-2021" report to their offering. ... The global voice recognition biometrics market ... The report covers the present scenario and the ... To calculate the market size, the report considers the revenue generated ...
(Date:1/18/2017)... 18, 2017  In vitro diagnostic (IVD) companies were ... acquisitions (M&A), and Kalorama Information expects that trend to ... been shifting. Generally, uncertainty in reimbursement and healthcare reform ... has changed the acquisitions landscape. Instead of looking to ... buying partners outside of their home country and also ...
(Date:1/12/2017)... SAN DIEGO , Jan. 12, 2017  Trovagene, ... circulating tumor DNA (ctDNA) technologies, today announced that it ... Europe and the Middle ... biopsy tests.  This milestone marks the first wave of ... tests for urine and blood samples. The ...
Breaking Biology News(10 mins):
(Date:2/21/2017)... (PRWEB) , ... February 21, 2017 , ... ... and biotech research and development (R&D), today announced the establishment of Genedata Limited ... Managing Director Kevin Teburi, a recognized expert in life science informatics. Creating the ...
(Date:2/21/2017)... ... 21, 2017 , ... Creation Technologies, a private company and ... manufacturers (OEMs) , today announced it has received the ‘Highest Overall Customer Rating’ ... its category of electronics manufacturing services (EMS) providers with annual revenues over $500 ...
(Date:2/21/2017)... 21, 2017   Invitae Corporation (NYSE: NVTA), ... announced that members of the company,s management team will ... Care Conference on Monday, March 6, 2017 at approximately ... Boston, Massachusetts . The ... by visiting the investors section of the company,s website ...
(Date:2/20/2017)... 20, 2017 This report analyzes the worldwide markets ... Types: Xylanase, Amylase, Cellulase, and Others. The report provides separate ... Japan , Europe , ... , and Rest of World. Read the ... forecasts are provided for the period 2015 through 2022. Also, ...
Breaking Biology Technology: