Featured Research

from universities, journals, and other organizations

First US trial of bone-marrow stem cells for heart attack patients appears safe

Date:
September 15, 2010
Source:
Minneapolis Heart Institute Foundation
Summary:
The first randomized, placebo-controlled US clinical trial to assess the use of bone marrow-derived mononuclear cells 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.

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.

Related Articles


"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 fraction -- some 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.

This study was supported by the Jon H. Dehaan Foundation. Cell processing was supported by the Production Assistance for Cellular Therapies. The infusion catheters were supplied by Boston Scientific, headquartered in Natick, Mass.


Story Source:

The above story is based on materials provided by Minneapolis Heart Institute Foundation. Note: Materials may be edited for content and length.


Journal Reference:

  1. Traverse et al. Results of a phase 1, randomized, double-blind, placebo-controlled trial of bone marrow mononuclear stem cell administration in patients following ST-elevation myocardial infarction. American Heart Journal, 2010; 160 (3): 428 DOI: 10.1016/j.ahj.2010.06.009

Cite This Page:

Minneapolis Heart Institute Foundation. "First US trial of bone-marrow stem cells for heart attack patients appears safe." ScienceDaily. ScienceDaily, 15 September 2010. <www.sciencedaily.com/releases/2010/09/100914115236.htm>.
Minneapolis Heart Institute Foundation. (2010, September 15). First US trial of bone-marrow stem cells for heart attack patients appears safe. ScienceDaily. Retrieved November 28, 2014 from www.sciencedaily.com/releases/2010/09/100914115236.htm
Minneapolis Heart Institute Foundation. "First US trial of bone-marrow stem cells for heart attack patients appears safe." ScienceDaily. www.sciencedaily.com/releases/2010/09/100914115236.htm (accessed November 28, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Friday, November 28, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Ebola Leaves Orphans Alone in Sierra Leone

Ebola Leaves Orphans Alone in Sierra Leone

AFP (Nov. 27, 2014) — The Ebola epidemic sweeping Sierra Leone is having a profound effect on the country's children, many of whom have been left without any family members to support them. Duration: 01:02 Video provided by AFP
Powered by NewsLook.com
Experimental Ebola Vaccine Shows Promise In Human Trial

Experimental Ebola Vaccine Shows Promise In Human Trial

Newsy (Nov. 27, 2014) — A recent test of a prototype Ebola vaccine generated an immune response to the disease in subjects. Video provided by Newsy
Powered by NewsLook.com
Pet Dogs to Be Used in Anti-Ageing Trial

Pet Dogs to Be Used in Anti-Ageing Trial

Reuters - Innovations Video Online (Nov. 26, 2014) — Researchers in the United States are preparing to discover whether a drug commonly used in human organ transplants can extend the lifespan and health quality of pet dogs. Video provided by Reuters
Powered by NewsLook.com
Today's Prostheses Are More Capable Than Ever

Today's Prostheses Are More Capable Than Ever

Newsy (Nov. 26, 2014) — Advances in prosthetics are making replacement body parts stronger and more lifelike than they’ve ever been. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:

Strange & Offbeat Stories

 

Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins