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Mesenchymal stromal stem cell injection improved heart function in patients with HF
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WASHINGTON — Intramyocardial injection of mesenchymal stromal stem cells derived from bone marrow improved end-systolic volume, quality of life and other outcomes in patients with severe ischemic heart disease and HF, according to findings from the phase 2 MSC-HF trial.
Researchers for the trial randomly assigned 59 patients with NYHA class II or III HF to receive intramyocardial injection of mesenchymal stromal cells (n=39) or placebo (n=20). The patients’ mean age was 65 years and mean left ventricular ejection fraction was 28.1%. The researchers said these patients with severe disease had no other available options for treatment.
Stem cells were extracted and isolated from a small amount of bone marrow collected from the patients, and were induced to self-replicate. Autotransplantation into the myocardium was performed via a catheter with a retractable needle inserted into an artery in the groin.
The primary endpoint of the study was end-systolic volume.
At 6 months after the procedure, patients in the stem-cell group had significantly reduced end-systolic volume compared with patients in the placebo group (–8.2 mL decrease vs. 6 mL increase; P=.001). The researchers also reported significant improvements in EF (5.5% increase vs. –1.4% decrease), end-systolic myocardial mass (10.1 g increase vs. –2.1 g decrease) and stroke volume (17.4 mL increase vs. –3.1 mL decrease; P<.0001 for all).
Among 17 evaluable patients, scar tissue mass was significantly reduced in the stem-cell group (–4.4 g; P=.017), but not in the placebo group (–0.5 g; P=.755). However, the difference between the groups was not statistically significant, the researchers said.
Both the stem cell and placebo groups also experienced improvements in NYHA Class, 6-minute walk test distance and the Kansas City Cardiomyopathy Questionnaire, but no significant difference was observed between the groups.
Anders Brunn Mathiasen
“In the MSC-HF trial, we demonstrated that stem cells can regenerated failing hearts," Anders Brunn Mathiasen, MD, of Rigshospitalet University Hospital in Copenhagen, said at a press conference. “Stem-cell treatment in patients with severe HF is safe and, compared to placebo, the treatment improved heart pump function and increased heart muscle mass. [Also] there was a reduction in scar tissue, and there were fewer symptoms and better quality of life in both groups of patients." – by Adam Taliercio
For more information:
Mathiasen AB. Abstract #405-16. Presented at: American College of Cardiology Scientific Sessions; March 29-31, 2014; Washington, D.C.
Disclosure: Mathiasen reports no relevant financial disclosures.