TiGenix reports success for AlloCSC-01 in Phase I/II heart failure study

TiGenix, a Belgium-based biopharmaceutical company, has announced promising results from its Phase I/II study assessing the safety and efficacy of AlloCSC-01, its innovative stem cell therapy for patients at risk of heart failure following a coronary attack. The study marks a significant advance in the field of cardiac health and stem cell therapy.

Groundbreaking Results in Cardiac Recovery

The cardiac stem cell study, known as CAREMI, did not register any side effects in patients who were treated with donor-derived expanded cardiac stem cells (AlloCSCs) and survived more than 30 days, six months, and twelve months post-treatment. This milestone confirms the long-term safety of the treatment and opens doors to potentially life-saving applications in cardiac care.

Dr. Marie Paule Richard, Chief Medical Officer at TiGenix, shared her optimism about the trial’s outcomes: “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.”

Details of the CAREMI Trial

The CAREMI trial targeted patients with acute myocardial infarction (AMI), commonly known as a heart attack, particularly those treated within the first week of left ventricular dysfunction post-AMI. This study is the first-in-human clinical trial to explore the effects of intracoronary infusion of AlloCSCs in such a setting.

TiGenix reported that the trial successfully met all its safety objectives, with no mortality or major cardiac adverse events (MACE) recorded at 30 days, fulfilling its primary endpoint. More notably, in a subgroup of patients with a poor long-term prognosis, there was a significant reduction in infarction size and associated mortality risks.

Advanced MRI Analysis and Immunological Profiling

The trial is distinguished by its use of comprehensive MRI analysis to select patients with large myocardial infarctions, integrating innovative cell therapy protocols. Professor Janssens, the principal investigator in Belgium, highlighted the advanced approach: “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.”

The success of the CAREMI trial represents a promising development in the treatment of heart attack survivors. By harnessing the regenerative potential of stem cells, TiGenix is pioneering a path that could lead to substantial improvements in cardiac care and patient outcomes.