Heart failure
Randomized trial of adult stem cells in HF shows benefit
Mon, 26 Apr 2004 16:15:00 | Allison Gandey

Toronto, ON - A randomized trial of autologous adult stem-cell transplantation for the treatment of congestive heart failure has shown an improvement in cardiac function. "Patients who received stem cells decreased functional class by almost two," lead researcher Dr Amit Patel (University of Pittsburgh School of Medicine, PA) told heartwire. He explained that in many cases, patients with severe heart failure, defined as NYHA heart failure class 3 or 4, dropped down to class 1 or 2. Results of the study were presented April 25 at the annual meeting of the American Association for Thoracic Surgery.

Patel noted that autologous adult stem-cell transplantation has been used to treat many diseases, but its use in cardiovascular disease has been performed only recently. In this study, the novel epicardial technique to deploy stem cells was compared with conventional therapy.

Patel and colleagues performed adult autologous stem-cell transplantations in patients with coronary artery disease who had an ejection fraction <35% and who were undergoing primary off-pump CABG. Using bone marrow from the patient's hipbone, the team extracted CD34+ and CD45- cells. "This was a truly one-step process," Patel said. "The harvesting and therapy were all done with one anesthetic."

The research team prospectively randomized the patients before operative treatment. Patients were given an echocardiogram and underwent stress thallium imaging single-photon-emission computed tomography (SPECT) and a cardiac catheterization before surgery. These imaging modalities were used to identify ischemic regions of the heart and to guide in mapping for injection of the stem cells.


No perioperative arrhythmias or neurological or ischemic myocardial events

The 20 patients in the study underwent treatment at centers in South America. Patient follow-up was at one, three, and six months with echocardiogram, SPECT, and angiography.

In the study group, 10 patients had successful transplantations of autologous stem cells into ischemic myocardium. The other 10 patients in the control group had only off-pump CABG. The median number of grafts performed was one for both groups. On angiographic follow-up, all grafts were patent at six months.

Patel and colleagues report there were no perioperative arrhythmias or neurological or ischemic myocardial events in either group. At one, three, and six months, the researchers found improvement in perfusion on SPECT imaging in areas injected with stem cells. The ejection-fraction rates for the stem-cell patients were significantly enhanced compared with the other patients.

Mean ejection fraction (%)

Follow-up

Control group

Study group

p

Preoperatively

30.7+2.5
29.4+3.6
0.381

One month

36.4+2.6
42.1+3.5
0.002

Three months

36.5+3.0
45.5+2.2
0.0004

Six months

37.2+3.4
46.1+1.9
0.0007
To download table as a slide, click on slide logo below

"These results encourage us to aggressively pursue cellular therapies as an option for congestive heart failure," coauthor Dr Robert Kormos (University of Pittsburgh School of Medicine) said in a news release. "It will revolutionize our approach, which is largely palliative, to one that is truly regenerative."

The researchers conclude that improvement in cardiac function after autologous stem-cell transplantation is promising but further investigation is required to quantify the cellular effects of the therapy.





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