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Heart Failure
+1

Impact of Intracoronary Injection of Autologous BMMC for LV Contractility and Remodeling in Patients With STEMI

Sponsored by American Heart of Poland

About this trial

Last updated 6 years ago

Study ID

AHP-001

Status

Unknown status

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

This is multicentre, randomised open-label, controlled, parallel-group phase III study. Its aim is to demonstrate that a triple intracoronary infusion of autologous bone marrow-derived mononuclear cells in addition to state of the art treatment is safe and reduces all-cause mortality in patients with reduced left ventricular ejection fraction (≤45%) after successful reperfusion for acute myocardial infarction when compared to a control group of patients undergoing best medical care.

What are the participation requirements?

Yes

Inclusion Criteria

1. Men and women of any ethnic origin aged ≥ 18 years.

2. Patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI.

3. Successful acute reperfusion therapy (residual stenosis visually <50% and TIMI flow ≥2) within 24 hours of symptom onset or thrombolysis within 12 hours of symptom onset followed by successful percutaneous coronary intervention (PCI) within 24 hours after thrombolysis.

4. Left ventricular ejection fraction ≤ 45% with significant regional wall motion abnormality assessed by quantitative echocardiography (central, independent core lab analysis) 3 to 6 days after reperfusion therapy

5. Open coronary artery suitable for cell infusion supplying the target area of abnormal wall motion

6. LVEF≤45% with significant regional wall motion abnormality assessed by computed tomography (CT) 30 days after reperfusion therapy with no LVEF improvement ≥5%.

No

Exclusion Criteria

1. Participation in another clinical trial within 30 days prior to randomisation

2. Previously received stem/progenitor cell therapy

3. Pregnant or nursing women

4. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol

5. Necessity to revascularise additional vessels, outside the target coronary artery at the time of BM-MNC infusion (additional revascularisations after primary PCI and before BM-MNC cell infusion are allowed)

6. Cardiogenic shock requiring mechanical support

7. Platelet count <100,000/μl, or hemoglobin <8.5 g/dl

8. Impaired renal function, i.e. serum creatinine >2.5 mg/dl

9. Persistent fever or diarrhea not responsive to treatment within 4 weeks prior screening

10. Clinically significant bleeding within 3 months prior screening

11. Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg)

12. Life expectancy of less than 2 years from any non-cardiac cause or neoplastic disease

Locations

Location

Status