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

NCT02323620 | Unknown Phase 3 DMC

• 1 other identifier: AHP-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Myocardial Infarction

Keywords

Acute myocardial Infarction; bone marrow; stem cells; cardiovascular disease; mortality

Outcome Measures

Primary Outcomes (1)

• Left ventricle ejection fraction change evaluated by CT

  12 months

Secondary Outcomes (4)

• Change in left ventricle End-Systolic Volume (ESV) and End-Diastolic Volume (EDV) evaluated by CT

  12 months

• Time from randomisation to cardiac death

  3 years

• Time from randomisation to cardiovascular death or rehospitalisation due to heart failure

  3 years

• Incidence and severity of adverse events

  3 years

Study Arms (2)

Standard care

NO INTERVENTION

Optimal standard care after myocardial infarction.

Intracoronary infusion of BM-MC

EXPERIMENTAL

Bone marrow-derived progenitor autologous cells aspiration and intracoronary infusion of the cells.

Procedure: Intracoronary infusion of BM-MC

Interventions

Intracoronary infusion of BM-MC PROCEDURE

Bone marrow-derived progenitor cells are obtained from 60ml bone marrow aspirated from the iliac crest. Intracoronary infusion of the autologous cells is performed via conventional percutaneous intracoronary intervention techniques using an over-the-wire balloon technique.

Intracoronary infusion of BM-MC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women of any ethnic origin aged ≥ 18 years.
• Patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI.
• 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.
• 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
• Open coronary artery suitable for cell infusion supplying the target area of abnormal wall motion
• LVEF≤45% with significant regional wall motion abnormality assessed by computed tomography (CT) 30 days after reperfusion therapy with no LVEF improvement ≥5%.

You may not qualify if:

• Participation in another clinical trial within 30 days prior to randomisation
• Previously received stem/progenitor cell therapy
• Pregnant or nursing women
• Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
• 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)
• Cardiogenic shock requiring mechanical support
• Platelet count \<100,000/μl, or hemoglobin \<8.5 g/dl
• Impaired renal function, i.e. serum creatinine \>2.5 mg/dl
• Persistent fever or diarrhea not responsive to treatment within 4 weeks prior screening
• Clinically significant bleeding within 3 months prior screening
• Uncontrolled hypertension (systolic \>180 mmHg and diastolic \>120 mmHg)
• Life expectancy of less than 2 years from any non-cardiac cause or neoplastic disease

Sponsors & Collaborators

• American Heart of Poland: lead

Study Sites (1)

Polsko-Amerykańskie Kliniki Serca

Ustroń, 43-450, Poland

Location

MeSH Terms

Conditions

Heart Failure; Myocardial Infarction; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Pawel E Buszman, MD, PhD

  American Heart of Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pawel E. Buszman, MD, PhD,

CONTACT

(+48) 607358348; pbuszman@ka.onet.pl

Stanislaw A. Trznadel, MD

CONTACT

(+48) 502035700; strznadel@vp.pl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: December 23, 2014
• Study Start: March 1, 2019
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 23, 2019

Record last verified: 2018-12

Locations

PL (1)