TiGenix has announced that its cardiac stem cell study assessing its heart attack stem cell therapy with AlloCSC-01 was successful in patients having the risk of heart failure following a coronary attack.
Tigenix Heart Attack Stem Cell Therapy with AlloCSC-01
The Belgium biopharma stated that its Phase I/II study of donor-derived expanded cardiac stem cells (AlloCSC) registered no side-effects in the treated patients who survived more than 30 days, six months and 12 months.
Dr. Marie Paule Richard, Chief Medical Officer at TiGenix on the results of the heart attack stem cell therapy trial said: “Besides confirming the long term safety of the treatment these results suggest interesting opportunities in populations with high unmet medical need.
“We look forward to working with our advisors to analyze the data in depth and determine the best way forward with AlloCSC-01 during the second half of this year.”
Tigenix Cardiac Stem Cell Trial Details
The trial studied AlloCSCs in acute myocardial infarction (AMI), or in simple words, a heart attack. Named as CAREMI, it is the first-in-human clinical trial studying an intracoronary infusion of AlloCSCs in AMI patients whose left ventricular dysfunction was treated within the first week after AMI.
According to the Belgian cell therapy company, the trial had met all its safety objectives, recording no mortality or major cardiac adverse events (MACE) at 30 days of meeting its primary endpoint.
In a subgroup of patients in the heart attack stem cell therapy trial who had a poor long-term outlook, a larger reduction in the infarction size was noted along with death caused by insufficient supply of blood.
The cardiac stem cell study happens to be the first study where a comprehensive MRI analysis has been used to include patients having a large myocardial infarction in an innovative cell therapy protocol.
Professor Janssens, the principal investigator of the heart attack stem cell therapy study in Belgium added: “Serial MRI analysis and extensive immunological profiling will allow us to further explore the encouraging signals we observed in cell treated patients with the worst MRI signature.
“These findings offer an exciting prospect for targeted follow-up studies in these high-risk patients.”