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 by PCI (TIMI = 3), but intermediate-high risk of HF development (infarct size by MRI>25%); Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-18
• Last Update Posted: 27 February 2017

Recruitment & Eligibility

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

Inclusion Criteria

Initial clinical pre-screening:
1. Males and females > or =18 years and < or = 80 years
2. Patients who present a STEMI according to the universally accepted definition found in the STEMI management guide of the European Society of Cardiology
3. Killip < or = 2 on admission
4. Successful revascularization by PCI (TIMI = 3) within 12 hours after the onset of symptoms.
5. Ejection Fraction (EF) =50% by echocardiography performed more than 48 hours after hospital admission and before the screening MRI done between day 3 and day 5 after infarction.
6. Bare-metal or drug-eluting stents of second generation (including new second generation stents, e.g. biolimus, novolimus, and bioreabsorbable stents) at coronary revascularization by PCI.
MRI analysis:
7. EF < or =45% (day 3 to 5 after STEMI)
8. Infarct size in LV analyzed by MRI > or = 25% of LV mass
Patients with infarct size = 25% of LV and EF slightly bigger than 45% could be included after evaluation and approval by the Study Coordinators and the Sponsor.
The presence of microvascular obstruction at MRI is permitted (needs to be indicated). Additional percutaneous interventions for additional coronary arteries revascularization are allowed if done 24h before the inclusion-MRI.
New catheterization for the administration of cells:
9. The infarct culprit coronary artery is adequate for treatment administration and the procedure is technically feasible.
10. The patient is stable and in adequate clinical condition to undergo the procedure.
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. Previous allogeneic transplant (blood transfusion are allowed) or treated with cell or gene therapy
3. Previous Q-wave infarction
4. Significant valve disease, relapsing pericarditis, history of cardiac tamponade, cardiomyopathies
5. Severe stenotic lesions (>90%) in a coronary vessel with size >2.75 mm not treated by PCI at least 24 hours before the baseline MRI study
6. Previous EF = or < 45%, NYHA > 2 or hospital admission for heart failure before STEMI
7. 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
8. Complete atrioventricular blockade, or acute left bundle branch block in the 48 hours prior to the product administration procedure
9. History of cardioembolic disease
10. Platelets <100,000 and/or Hb<8.5g/dL
11. Acute or chronic renal failure with creatinine =2.5 mg/dl or creatinine clearance =30 mL/min
12. Infection with systemic involvement
13. 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.
14. Child-Pugh's C stage chronic liver disease
15. Baseline respiratory failure requiring oxygen at home
16. Uncontrolled hypertension at screening despite treatment (systolic blood pressure [BP] = 180 and/or diastolic BP = 110)
17. Very poorly controlled diabetes (Hb1Ac =8.5 g/dL) or with serious target organ lesion (peripheral vascular disease requiring revascularization or non revascularizable)
18. History of autoimmune disease
19. Primary or acquired immune deficiency or immunosuppressant treatment (including treatments with immunosuppressants in the previous three months or foreseeable need for those treatments during the course of the study).
20. Women who are pregnant or breastfeeding or women of childbearing potential who do not agree to use contraceptives during the study period
21. Life expectancy of less than 2 years for any reason.
22. Allergy to amynoglicoside antibiotics or HSA hypersensitivity
23. Contraindications preventing the use of Magnetic Resonance Imaging: Pacemaker, Implantable cardioverter-defibrillator (ICD), known reaction to gadolinium, claustrophobia, cochlear implants

Study & Design

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