First-in-human clinical trial using human cardiac stem cells obtained from a donor for Acute Myocardial Infarction treatment. Patients will receive either cells or placebo by intracoronary infusion to evaluate the safety and efficacy of this treatment.

Phase 1

• Conditions: Acute Myocardial Infarction (AMI):First STEMI submitted to elective primary PCI with successful revascularization (TIMI ? 2), but intermediate-high risk of HF development (infarct size by MRI>25%; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-001358-81-ES
• Lead Sponsor: Coretherapix S.L.U.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-18
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. Adult patients ? 18 years of age and ? 80 years.
2. Patients presenting a ST-segment-elevation in the acute myocardial infarction (STEMI) according to the universally accepted definition founded in the STEMI management guide of the European Society of Cardiology
3. Killip ? 2 on admission
4. Successful primary percutaneous coronary intervention (PCI) (Thrombolysis In Myocardial Infarction [TIMI] = 3) during the first 12h after infarct symptoms
5. Bare-metal stent at primary PCI
6. Ejection Fraction (EF) ?45% analyzed by echocardiography at day 2 after primary PCI
7. Ejection Fraction (EF) ?45% analyzed by magnetic resonance imaging (MRI). This MRI will be done between day 3 and day 7 after infarction.
8. Patients with an infarct size in left ventricle (LV) ?25% tested in the first MRI will be included.
9. The affected coronary artery must be adequate for cells infusion by catheterization.
10. The presence of microvascular obstruction at inclusion MRI is permitted
11. The patient is stable and in adequate clinical condition to undergo the administration of the cell medicine through a second catheterization, between 4-7 days after the first PCI.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1. Participation in another clinical trial in the last 30 days
2. Has previously received cell or gene therapy
3. Women who are pregnant or breastfeeding
4. Mental disease or psychological condition that impedes the subject from understanding the nature of the protocol and granting his/her consent
5. Previous Q-wave infarction
6. Valve disease, relapsing pericarditis, history of cardiac tamponade, cardiomyopathies
7. Involvement of coronary trunk
8. Severe stenotic lesion (>90%) in a coronary vessel with size >2.75mm, shown in the first PCI and non revascularizable during primary PCI
9. Admission for prior HF or EF<45 or NYHA > 2 before STEMI
10. Killip >2 on admission
11. History of sustained VT or VF at any point since hospital admission
12. Sustained VT that does not revert with treatment or requires >6 hours to be controlled in the 48 hours prior to the product administration procedure
13. Complete Auriculo Ventricular blockade on arrival to the Emergency Room (previously unknown), or acute branch block during hospitalization
14. History of cardioembolic disease
15. Platelets <100,000 and/or Hb<8.5g/dL
16. Acute or chronic renal failure with creatinine ?2.5 or creatinine clearance ?50 mL/min
17. Infection with systemic involvement (fever or documented Systemic Inflammatory Response Syndrome) current and/or in the month prior to AMI
18. History of bleeding in the 3 months prior to screening in any location due to uncontrolled coagulopathy
19. Cancer disease, except that eradicated at least 5 years before inclusion, and without receiving radiotherapy on chest. It is permitted coetaneous non-melanoma neoplasms completely eliminated (at any time) and that do not require subsequent chemotherapy or radiotherapy on chest.
20. Child's C stage chronic liver disease
21. Stroke in the previous 12 months
22. Baseline respiratory failure and/or requires oxygen at home
23. Advanced dementia according to the Barthel index
24. History of autoimmune disease and/or positive autoantibodies at least double titer of the normal ranges
25. Patients with Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human Immunodeficiency virus (HIV) or asymptomatic carriers (positive without clinical disease) except positive for HBV by vaccination
26. Uncontrolled hypertension at screening despite treatment (systolic blood pressure [BP] ? 180 and/or diastolic BP ? 110)
27. Very poorly controlled diabetes (Hb1Ac ?8.5 g/dL) or with serious target organ lesion (peripheral vascular disease requiring revascularization or non revascularizable, CRF with creatinine clearance ?50 mL/min, stroke in the previous 12 months, severe non-revascularizable coronary disease)
28. Primary or acquired immune deficiency or immunosuppressant treatment (including treatments with immunosuppressants in the previous three months or with systemic corticosteroids in the previous month or foreseeable need for those treatments during the course of the study).
29. Very poorly controlled hypercholesterolemia (total cholesterol ?250 mg/dL despite treatment)
30. Active smoking greater than or equal to 40 cigarettes/day
31. Recreational drug use that would hamper heart or cardiovascular function, at least once in the past 6 months
32. Weekly alcohol consumption over 80 g per kg
33. Women of childbearing potential who do not agree to use contraceptives during the study period and up to 6 months afterwards
34. Life expectancy of less than 2 years for any reason.
35

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified