Safety and Efficacy Evaluation of Intracoronary Infusion of Allogeneic Human Cardiac Stem Cells in Patients With AMI
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Development of myocardial reparative therapy for the treatment of acute ischemic cardiac
      disease, based on the intracoronary administration of allogeneic Cardiac Stem Cells (CSCs) to
      ameliorate myocardial cell death and promote cardio-regeneration.

      The study comprises two phases:

        1. Initial dose-escalation open-label safety phase comprising 6 patients. Escalation will
           start with the Maximum Recommended Safe Dose (MRSD) calculated from Non-Observed Adverse
           Events Level (NOAEL) and it is expected to finish with the target dose (TD). There will
           be no placebo group for this initial phase.

        2. Randomized double-blind placebo-controlled safety and efficacy phase in which the TD
           will be injected if the dose-escalation phase is completed successfully.
    

Detailed description: 
      This is a "First in Patient" Clinical Trial to obtain safety and efficacy results about the
      intracoronary administration of a suspension of allogeneic cardiac stem cells (CSCs) for the
      treatment of ST elevation Myocardial Infarction (STEMI). This clinical trial will have 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.

      Patients with EF<45% and with infarct sizes > 25% will be selected by magnetic resonance
      image (MRI). 49 patients will be included in the randomized phase with the aim of having 38
      patients for efficacy analysis at the end of the follow up period (12 months). In this phase,
      patients will be randomly allocated for receiving CSCs or placebo in a 2:1 scheme. Three
      bioequivalent cellular batches obtained from different donors will be indistinctly used
      during the assay.

      CSCs or placebo treatment will be infused into the coronary artery responsible for the
      ischemic event. Placebo will be a commercial preparation of human serum albumin 5% in saline
      solution that will also be used for cell product reconstitution.

      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.

      Finally, cellular and humoral immunological response (screening for anti-HLA (Human Leukocyte
      Antigen) class I and class II antibodies, HLA typing, cross-matching between cells and
      treated patient and cytokine profiling in blood samples) will be analysed during the clinical
      trial.
    

Intervention name(s): Allogeneic human cardiac stem cells (CSCs); Human Serum Albumin-HSA 5%
Intervention type(s): Biological; Other
Intervention description(s): Allogeneic human CSCs is a new cell medicine based on cells isolated from human heart biological samples (right atrium appendage of donors) and expanded in vitro.; Human Serum Albumin (HSA) is a well-known physiologic protein widely used in clinical practice and without known toxicity after parenteral administration.
Other intervention name(s): AlloCSC-01
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment