ICMNC-HF. IntraCoronary Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients

SCARM Institute, Tabriz, Iran

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Heart Failure

Treatments: Biological: Placebo; Biological: Intracoronary injection of stem cell

Study type: Interventional

Funder types: Other

Identifiers

NCT03145402

SCARM-Heart-001

Details and patient eligibility

About

This is a prospective, randomised double blind, controlled, parallel-group phase I and II study. Its aim is to assess that a single intracoronary infusion of autologous bone marrow-mononuclear cells is safe and effective in hear failure patients with reduced left ventricular ejection fraction(<=30%) when compared to a control group of patients undergoing best medical care.

Enrollment: 5 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Men and women of any ethnic origin 18 ≤ aged≤ 65 years
2. EF≤40 (by Echocardiography) and regional wall motion abnormality
3. Not responding to standard therapies
4. the New York Heart Association (NYHA) class ≥ III
5. Myocardial infarction due to coronary artery atherosclerotic disease
6. An area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or MRI)
7. Normal liver and renal function
8. No or controlled diabetes
9. Able to give voluntary written consent and understand the study information provided to him

Exclusion criteria

1. Participation in another clinical trial within 30 days prior randomisation
2. Previously received stem/progenitor cell therapy
3. Pregnant 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. Cardiogenic shock requiring mechanical support
6. Congenital / valvular heart disease
7. Implantable cardioverter defibrillator (ICD) transplant
8. Platelet count <100.000/µl, or hemoglobin <8.5 g/dl
9. Impaired renal function, i.e. creatinine >2.5 mg/dl
10. Fever or diarrhea within 4 weeks prior screening
11. History of bleeding disorder within 3 months prior screening
12. Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg) or Sustained ventricular arrhythmia
13. Life expectancy of less than two years from any non-cardiac cause or uncontrolled neoplastic disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups, including a placebo group

Intracoronary injection of stem cell

Experimental group

Description:

Autologous bone marrow-derived mononuclear cells injection in patients with Heart Failure

Treatment:

Biological: Intracoronary injection of stem cell

Placebo

Placebo Comparator group

Description:

Placebo injection via coronary arteries in patients with Heart Failure

Treatment:

Biological: Placebo