IMMNC-HF: IntraMyocardial Injection of Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients (IMMNC-HF)

Evaluation of the Intramyocardial Injection of Autologous Bone Marrow Derived Mononuclear Stem Cells in Heart Failure (HF) Patients

This is a prospective, randomised double blind, controlled, parallel-group phase I and II study. Its aim is to assess the Evaluation of the intramyocardial injection of autologous bone marrow derived mononuclear stem 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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Biological: Intramyocardial injection of stem cell; Biological: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 5
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tabriz, Iran, Islamic Republic of
    • Stem Cell And Regenerative Medicine institute (SCARM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intramyocardial injection of stem cell; Intramyocardial injection of autologous bone marrow mononuclear cells in patients with Heart Failure	Biological: Intramyocardial injection of stem cell; Autologous bone marrow-derived mononuclear cells are obtained from 100-150ml of bone marrow aspirated under local anaesthesia from the iliac crest. Intramyocardial injection of the cells is performed in patients with Heart failure in open heart surgery (CABG)
PLACEBO_COMPARATOR: Placebo; Placebo intramyocardial injection in patients with Heart Failure	Biological: Placebo; Injection of Placebo in patients with Heart failure in open heart surgery (CABG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	The rate of patients mortality after transplantation	12 months
Hospitalization	the rate of hospitalization after transplantation	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: SCARM Institute, Tabriz, Iran
• Investigators: Study Director: Nasser Safaie, CTS, Tabriz University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 14, 2020
• Primary Completion (ANTICIPATED): August 10, 2021
• Study Completion (ANTICIPATED): October 12, 2021

Study Registration Dates

• First Submitted: July 21, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (ACTUAL): July 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: SCARM-Heart-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No