Date: 2017-03-13
Type of
information: Results
phase: 1-2
Announcement: interim results
Company: Coretherapix (Spain), now Tigenix (Belgium)
Product: AlloCSC-01 - allogeneic human cardiac stem cells (CSCs)
Action
mechanism:
- stem cell therapy. AlloCSC-01 is a suspension of allogeneic human cardiac stem cells (CSC).
Disease: acute myocardial infarction
Therapeutic
area: Cardiovascular diseases
Country: Belgium, Spain
Trial
details:
- CAREMI is a two phase study consisting of an open-label dose-escalation phase I completed in June 2015, and a randomised, double-blind, placebo-controlled phase II, aiming at evaluating the safety and efficacy of intracoronary infusion of AlloCSC-01, a suspension of allogeneic human cardiac stem cells (CSCs), in patients that have suffered an acute myocardial infarction. The trial has a first dose-escalation phase in which the safety of 10, 20 and 35 million CSCs administration will be evaluated in 6 patients. A second double-blind randomized and placebo controlled phase will be initiated, if no major safety effects are observed during the first week after cell administration. The 35 million cells dose is the one expected to be used during the randomized phase.
- After treatment, patients will be monitored overnight in a coronary care unit for any toxicity and discharged from hospital 24h after treatment if no adverse events are observed. Subsequent safety follow-up will be done first at day 7 after treatment and then monthly or quarterly thereafter for 12 months. In addition, efficacy evaluations will be performed by MRI and clinical parameters at 1, 6 and 12 months after treatment.
- Eight clinical centers of reference in cardiology have participated in the CAREMI trial led by Prof. Fernández-Avilés of Hospital Gregorio Marañón in Madrid, Spain, and Prof. Stefan Janssens of KU Leuven, Belgium, as principal investigators. The CAREMI trial has been supported by the Seventh Framework Programme of the European Commission, a transnational research funding initiative, as part of the CARE-MI project (Grant Number 242038).(NCT02439398)
Latest
news:
- • On March 13, 2017, TiGenix announced one-year results from the CAREMI clinical trial, an exploratory Phase I/II study of AlloCSCs in acute myocardial infarction (AMI).
- CAREMI is the first-in-human clinical trial with the primary objective being safety and evaluating the feasibility of an intracoronary infusion of 35 million of AlloCSCs in patients with AMI and left ventricular dysfunction treated within the first week post-AMI. Importantly, 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. The main findings of this study are:
- All safety objectives of the study have been 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 have been 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. Full data results from the CAREMI study will be presented at an upcoming medical congress.
- • On June, 17, 2016, TiGenix announced preliminary six-month results from the CAREMI clinical trial. Enrollment in this first-in-human clinical trial was completed in November 2015 with 49 patients randomized (AlloCSC-01: placebo; 2:1). The preliminary interim data is comprised of the six-month follow up of the 49 randomized patients plus two patients from the escalation phase who received similar target doses of 35 million cells (51 in total).
As per the protocol design, the primary objective of this study is to provide evidence of the acute and long-term safety profile of AlloCSC-01. On the primary acute safety endpoint, no mortality of any cause within one month was recorded for both placebo and AlloCSC-01 groups. Similarly, no major adverse cardiac event (MACE) was recorded within one month in either group. Importantly for the long term safety evaluation, no MACE was recorded in either two group at six months. Preliminary secondary efficacy data at six months was limited to infarct size evolution, defined as a percent of the left ventricular mass measured by magnetic resonance imaging. The mean absolute change in infarct size from baseline to six months was similar in both groups. The final full set of safety and efficacy study results at twelve months will be reported in first half of 2017.
- • On November 19, 2015 , TiGenix announced that it has completed enrolment of its Phase II study in acute myocardial infarction. Enrolment of this second phase has been completed with the treatment of the last of the planned 49 patients. The trial has now entered in its 12 month follow-up period.
- • On September 23, 2015 , TiGenix announced that the CAREMI dose-escalation open-label phase data were presented at the Congress of the European Society of Cardiology. The study aimed at evaluating the safety and efficacy of intracoronary infusion of AlloCSC-01. In the dose-escalation open-label phase, 6 patients were treated with AlloCSC-01 and 5 of them were followed up for 6 months. Patients received a single injection of 11 million (M), 22M or 35M cells of AlloCSC-01 (n=2 each) by intracoronary infusion 5 to 7 days after Percutaneous Coronary Intervention (PCI). Data presented show that AlloCSC-01 has a good safety profile as no adverse events or Major Adverse Cardiac Events (MACE) were observed during the 6 month follow-up period.
Is
general: Yes
