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

Phase 1

• Conditions: Heart Failure
• Interventions: Biological: Intracoronary injection of stem cell; Biological: Placebo

• Registration Number: NCT03145402
• Lead Sponsor: SCARM Institute, Tabriz, Iran

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-09
• Status Verified: 2019-12
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-17
• Study Start: 2020-10-20
• Primary Completion: 2021-08-28
• Study Completion: 2021-10-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intracoronary injection of stem cell	Intracoronary injection of stem cell	Autologous bone marrow-derived mononuclear cells injection in patients with Heart Failure
Placebo	Placebo	Placebo injection via coronary arteries in patients with Heart Failure

Primary Outcome Measures

Name	Time	Method
Death	12 months	The rate of patients mortality after transplantation
Hospitalization	12 months	the rate of hospitalization after transplantation

Secondary Outcome Measures

Name	Time	Method
Ejection fraction changes	12 months	Elevation of ejection fraction in patients after transplantation
6-minute walk test (6MWT)	12 months	Evaluation the improvement of 6MWT test after transplantation
Pro b-type natriuretic peptide (Pro-BNP) changes	12 months	Elevation the reduction of Pro-BNP in patients after transplantation
NYHA functional class	12 months	Evaluation the improvement of NYHA functional class in patients

Trial Locations

Locations (1)

Stem Cell And Regenerative Medicine institute (SCARM); 🇮🇷 Tabriz, Iran, Islamic Republic of