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Top-Line phase 1/2 results of treatment for heart attack.

LEUVEN, Belgium, -- March 13, 2017 -- TiGenix NV (NASDAQ:TIG announced top-line one-year results from the CAREMI clinical trial, an exploratory Phase 1/2 study of AlloCSCs in acute myocardial infarction (AMI).

CAREMI is the first clinical trial with the primary objective of safety and feasibility of an intracoronary infusion of 35 million of AlloCSCs in heart attack patients with left ventricular dysfunction treated within the first week post-AMI.

The trial is the first cardiac stem cell study to integrate a highly discriminatory magnetic resonance imaging (MRI) strategy to select patients at increased risk of heart failure and late adverse outcomes.

CAREMI was not powered to establish efficacy therefore no conclusion can be drawn on the secondary efficacy end-points.

Main findings:

* All safety objectives of the study were met. No mortality or major cardiac adverse events (MACE) have been found at 30 days meeting the primary end-point of the study. Moreover, no mortality and MACE have been found at 6 months or 12 months follow-up

* Of particular relevance to this allogeneic approach, no immune-related adverse events were recorded at one-year follow-up

* A larger reduction in infarct size was found in one pre-specified subgroup associated with poor long-term prognosis and representing more than half of the patient population of the randomization phase of the study. This finding has revealed valuable insight, and provides a specific direction for potential studies in a targeted subset of high-risk patients

"This is the first trial in which it has been demonstrated that allogeneic cardiac stem cells can be transplanted safely through the coronary tree, and in the worst possible setting represented by patients with an acute heart attack with left ventricular dysfunction," said principal investigator Fernandez-Aviles of the Hospital General Universitario Gregorio Maranon (Madrid, Spain). "It is especially encouraging that no cardiac or immunological side effects were observed."

The principal investigator of the Beligian trial said it was the first study to use a state of the art comprehensive MRI analysis to include patients with a large myocardial infarction in an innovative cell therapy protocol.

Serial MRI analysis and extensive immunological profiling will allow further exploration of the encouraging signals observed in cell treated patients with the worst MRI signature.

The findings offer a prospect for targeted follow-up studies in these high-risk patients.


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Title Annotation:In The Clinic...
Publication:Stem Cell Business News
Article Type:Clinical report
Date:Mar 20, 2017
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