Navigation Links
First US trial of bone-marrow stem cells for heart attack patients proves safe
Date:9/14/2010

The first randomized, placebo-controlled U.S. clinical trial to assess the use of bone marrow-derived mononuclear cells (BMC) in patients after a ST-elevation myocardial infarction (STEMI; severe heart attack) demonstrated a strong safety profile for this cell therapy, based on phase 1 results published in the September issue of the American Heart Journal.

"The use of adult stem cells, derived from the patient's own bone marrow, presents a potential new type of therapy to benefit individuals after they suffer a heart attack," says the study's principal investigator Jay H. Traverse, MD, cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis, Minn. "Also, these types of stem cells do not possess any of the ethical concerns of embryonic stem cell research."

"While the objective of phase 1 clinical trials is to assess safety, researchers also look for hints of efficacy that have been revealed in previous studies," says Traverse. "Based on indications of some improvements in various European studies, we sought to examine whether this therapy could improve ejection fraction at six months, and whether it had an effect on attenuating adverse left ventricular remodeling as measured by cardiac MRI."

In this single-center trial, the researchers enrolled 40 patients with STEMI, randomizing them in a 3:1 ratio to 100 million autologous BMCs versus placebo, administered three to ten days following successful primary angioplasty and stenting of the left anterior descending coronary artery. Importantly, the researchers elected to deliver cells by an intracoronary infusion as opposed to the stop-flow technique that had been used in all preceding trials and all patients received an identical number of cells.

Administration of BMC was safely performed in all patients with minimal major adverse clinical event rates, and all patients remain alive to date, Traverse and colleagues reported.

While the BMC cell therapy was associated with a significant improvement in left ventricular ejection fraction at six months (49% to 55.2%), the study failed to demonstrate that the cell therapy was superior to placebo because of the similar improvement in the small placebo group (48.6% to 57%). However, the BMC group experienced a significant improvement in left-ventricular volumes at six months compared with the placebo group.

"A review of the available clinical literature reveals a split in the benefit of left ventricular ejection fractionsome studies show no benefit and others show a small improvement," Traverse explains. "Any number of factors can influence this outcome: the way the ejection fraction is measured, the timing of BMC administration, how many cells are delivered, the type of STEMI patient population. There are a lot of variables, leading some to question whether ejection fraction is the most appropriate endpoint for cell therapy trials."

"To this point, no study has been properly powered to assess the appropriate timing of BMC administration after a heart attack," says Traverse.

However, Traverse and his colleagues at the Minneapolis Heart Institute are involved with the TIME trial, sponsored by the National Heart, Lung and Blood Institute's Cardiovascular Cell Therapy Research Network (CCTRN), which is randomizing patients to BMCs at three or seven days post-STEMI to determine the most appropriate timing to administer the stem cells following a heart attack.


'/>"/>

Contact: Meghan Bethke
mbethke@mhif.org
612-863-5410
Minneapolis Heart Institute Foundation
Source:Eurekalert

Related biology news :

1. Terumo Medical Corp. reports first US implant in landmark study enrolling in US and Japan
2. First discovery of bilirubin in a flower announced
3. Carnegie Mellon hosting first conference to explore scientific use of gigapixel imagery
4. First genetic link to common migraine exposed
5. Healthy ears hear the first sound, ignoring the echoes
6. Genetic structure of first animal to show evolutionary response to climate change determined
7. Smithsonian scientists help create first frozen repository for Hawaiian coral
8. Creation of the first frozen repository for Hawaiian coral
9. Scientists find the first evidence of genetically modified plants in the wild
10. First satellite measurement of water volume in Amazon floodplain
11. Genome of ancient sponge reveals origins of first animals, cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/19/2016)... DUBAI , UAE, April 20, 2016 ... can be implemented as a compact web-based "all-in-one" system ... in the biometric fingerprint reader or the door interface ... requirements of modern access control systems. The minimal dimensions ... the ID readers into the building installations offer considerable ...
(Date:4/14/2016)... , April 14, 2016 ... and Malware Detection, today announced the appointment of ... the new role. Goldwerger,s leadership appointment comes ... the heels of the deployment of its platform at ... behavioral biometric technology, which discerns unique cognitive and physiological ...
(Date:3/31/2016)... , March 31, 2016  Genomics firm Nabsys has ... CEO, Barrett Bready , M.D., who returned to ... the original technical leadership team, including Chief Technology Officer, ... Product Development, Steve Nurnberg and Vice President of Software ... the company. Dr. Bready served as CEO ...
Breaking Biology News(10 mins):
(Date:6/27/2016)... ... June 27, 2016 , ... Newly created 4Sight Medical ... to the healthcare market. The company's primary focus is on new product introductions, ... strategies that are necessary to help companies efficiently bring their products to market. ...
(Date:6/24/2016)... , June 24, 2016 Epic ... sensitively detects cancers susceptible to PARP inhibitors by ... tumor cells (CTCs). The new test has already ... therapeutics in multiple cancer types. Over ... DNA damage response pathways, including PARP, ATM, ATR, ...
(Date:6/23/2016)... 2016   Boston Biomedical , an industry ... to target cancer stemness pathways, announced that its ... Drug Designation from the U.S. Food and Drug ... including gastroesophageal junction (GEJ) cancer. Napabucasin is an ... cancer stemness pathways by targeting STAT3, and is ...
(Date:6/23/2016)... Prostate Cancer Foundation (PCF) is pleased to announce 24 new Young ... cancer. Members of the Class of 2016 were selected from a pool of ... More About the Class of 2016 PCF Young Investigators ... ... ...
Breaking Biology Technology: