Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

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

10.11.2005


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.

George Stamatis | EurekAlert!
Further information:
http://www.case.edu

More articles from Life Sciences:

nachricht Transport of molecular motors into cilia
28.03.2017 | Aarhus University

nachricht Asian dust providing key nutrients for California's giant sequoias
28.03.2017 | University of California - Riverside

All articles from Life Sciences >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: A Challenging European Research Project to Develop New Tiny Microscopes

The Institute of Semiconductor Technology and the Institute of Physical and Theoretical Chemistry, both members of the Laboratory for Emerging Nanometrology (LENA), at Technische Universität Braunschweig are partners in a new European research project entitled ChipScope, which aims to develop a completely new and extremely small optical microscope capable of observing the interior of living cells in real time. A consortium of 7 partners from 5 countries will tackle this issue with very ambitious objectives during a four-year research program.

To demonstrate the usefulness of this new scientific tool, at the end of the project the developed chip-sized microscope will be used to observe in real-time...

Im Focus: Giant Magnetic Fields in the Universe

Astronomers from Bonn and Tautenburg in Thuringia (Germany) used the 100-m radio telescope at Effelsberg to observe several galaxy clusters. At the edges of these large accumulations of dark matter, stellar systems (galaxies), hot gas, and charged particles, they found magnetic fields that are exceptionally ordered over distances of many million light years. This makes them the most extended magnetic fields in the universe known so far.

The results will be published on March 22 in the journal „Astronomy & Astrophysics“.

Galaxy clusters are the largest gravitationally bound structures in the universe. With a typical extent of about 10 million light years, i.e. 100 times the...

Im Focus: Tracing down linear ubiquitination

Researchers at the Goethe University Frankfurt, together with partners from the University of Tübingen in Germany and Queen Mary University as well as Francis Crick Institute from London (UK) have developed a novel technology to decipher the secret ubiquitin code.

Ubiquitin is a small protein that can be linked to other cellular proteins, thereby controlling and modulating their functions. The attachment occurs in many...

Im Focus: Perovskite edges can be tuned for optoelectronic performance

Layered 2D material improves efficiency for solar cells and LEDs

In the eternal search for next generation high-efficiency solar cells and LEDs, scientists at Los Alamos National Laboratory and their partners are creating...

Im Focus: Polymer-coated silicon nanosheets as alternative to graphene: A perfect team for nanoelectronics

Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are less stable. Now researchers at the Technical University of Munich (TUM) have, for the first time ever, produced a composite material combining silicon nanosheets and a polymer that is both UV-resistant and easy to process. This brings the scientists a significant step closer to industrial applications like flexible displays and photosensors.

Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

International Land Use Symposium ILUS 2017: Call for Abstracts and Registration open

20.03.2017 | Event News

CONNECT 2017: International congress on connective tissue

14.03.2017 | Event News

ICTM Conference: Turbine Construction between Big Data and Additive Manufacturing

07.03.2017 | Event News

 
Latest News

Transport of molecular motors into cilia

28.03.2017 | Life Sciences

A novel hybrid UAV that may change the way people operate drones

28.03.2017 | Information Technology

NASA spacecraft investigate clues in radiation belts

28.03.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>