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LateTIME: Despite safety, no benefit to bone marrow cell therapy weeks after MI

Issue: February 2012

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AHA Scientific Sessions 2011

ORLANDO, Fla. — Harvesting and delivering autologous bone marrow mononuclear cells via intracoronary infusion was safely and effectively performed 2 to 3 weeks after percutaneous coronary intervention during a randomized, double blind, placebo-controlled trial of the Cardiovascular Cell Therapy Research Network.

However, there was no improvement in global or regional left ventricular function, as assessed by cardiac MRI, according to Jay H. Traverse, MD, FACC, FAHA, of the Minneapolis Heart Institute. Traverse presented results of the LateTIME trial.

The trial was conducted to determine whether cell delivery could be delayed 2 to 3 weeks after MI to include a broader range of patients, such as those lacking clinical stability or those who present outside a clinical trial center, according to Traverse. They also assessed whether changes in the myocardium or bone marrow would modify the homing and engraftment of bone marrow cells if delivered several weeks post-MI.

Eighty-seven patients who underwent PCI with stenting and had post-MI LVEF <45% were included in the study, which was conducted at five Cardiovascular Cell Therapy Research Network sites and their satellites. Between July 2008 and February 2011, patients were randomly assigned to bone marrow aspiration and isolation of bone marrow cells (BMCs) followed by intracoronary infusion of 150 million bone marrow mononuclear cells or cell-free placebo within 12 hours of harvest. Cardiac MRI was used to assess changes in global and regional LV function at 6 months; these were the co-primary endpoints.

From baseline to 6-months follow-up, there was no significant difference in LVEF between the two groups (48.7% to 49.2% vs. 45.3% to 48.8%). Similarly, there was no statistically significant treatment effect on wall motion in the infarct zone (6.2 mm to 6.5 mm vs. 4.9 mm to 5.9 mm) or border zone (16.0 mm to 16.6 mm vs. 16.1 mm to 19.3 mm), and there was no significant change in LV volumes, according to Traverse.

“We found that intracoronary delivery of autologous bone marrow mononuclear cells can be safely delivered 2 to 3 weeks following primary angioplasty stenting after moderate to large acute MI,” Traverse said. “However, we observed no improvement in global or regional LV function at 6 months by cardiac MRI in response to intracoronary delivery.” – by Stacey L. Fisher

For more information:

• Traverse JH. CS.01. Presented at: American Heart Association Scientific Sessions 2011; Nov. 12-16, 2011; Orlando, Fla.
• Traverse JH. JAMA. 2011;306:2110-2119.

Disclosure: Dr. Traverse reports no relevant financial disclosures.

What are the strengths of LateTIME? The rigorous design, state-of-the-art quality control of the cells, automated cell processing and [this is] the first study to use a defined cell dose. Importantly, [it included] the use of the gold standard of imaging: the MRI technique, and the use of true placebo control, allowing true blinding. The weaknesses are that it’s still a relatively small study in a highly selective study population.
What are potential reasons for the negative results? The most obvious is timing; it could be the late time point is the reason for the negative effect. The cells were formerly not tested for efficiency in an animal model, but all of the in vitro data argue against this reason. The low patient number, of course, could give rise to a false-negative effect just by chance. It could also mean that bone marrow cell therapy is inefficient.
The researchers for this study should be applauded for a rigorously designed, well-executed study with a clear outcome. The bone marrow cell therapy 2 to 3 weeks after MI was safe, but had no beneficial effect. In my opinion, LateTIME adds to a number of recent bone marrow cell trials with a neutral outcome arguing against the reporting efficacy of bone marrow cell therapy in acute or sub-acute MI.

- Thomas Eschenhagen, MD

University Medical Center, Hamburg, Eppendorf

Disclosure: Dr. Eschenhagen reports no relevant financial disclosures.

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