Safety and Efficacy Evaluation of Intracoronary Infusion of Allogeneic Human Cardiac Stem Cells in Patients With AMI

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.

Conditions

• Acute Myocardial Infarction

Interventions

BIOLOGICAL

Allogeneic human cardiac stem cells (CSCs)

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.

OTHER

Human Serum Albumin-HSA 5%

Human Serum Albumin (HSA) is a well-known physiologic protein widely used in clinical practice and without known toxicity after parenteral administration.

Sponsors & Collaborators

• European Commission

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• Saint-Louis Hospital, Paris, France

  collaborator OTHER

• Hospital General Universitario Gregorio Marañon

  collaborator OTHER

• Complejo Hospitalario de Navarra

  collaborator OTHER

• Hospital Clínico Universitario de Valladolid

  collaborator OTHER

• Hospital Donostia

  collaborator OTHER

• Hospital Clínico Universitario de Valencia

  collaborator OTHER

• University of Salamanca

  collaborator OTHER

• Hospital Universitario Virgen de la Victoria

  collaborator OTHER

• Coretherapix

  lead INDUSTRY

Principal Investigators

• Marie Paule Richard, MD · Coretherapix (Tigenix Group)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-06-30

Primary Completion

2015-12-31

Completion

2016-11-14

Countries

• Spain

Study Locations