Back to resultsICMNC-HF. IntraCoronary Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients (ICMNC-HF)
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Intracoronary injection of stem cell
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Men and women of any ethnic origin 18 ≤ aged≤ 65 years
- EF≤40 (by Echocardiography) and regional wall motion abnormality
- Not responding to standard therapies
- the New York Heart Association (NYHA) class ≥ III
- Myocardial infarction due to coronary artery atherosclerotic disease
- An area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or MRI)
- Normal liver and renal function
- No or controlled diabetes
- Able to give voluntary written consent and understand the study information provided to him
Exclusion Criteria:
- Participation in another clinical trial within 30 days prior randomisation
- Previously received stem/progenitor cell therapy
- Pregnant women
- Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
- Cardiogenic shock requiring mechanical support
- Congenital / valvular heart disease
- Implantable cardioverter defibrillator (ICD) transplant
- Platelet count <100.000/µl, or hemoglobin <8.5 g/dl
- Impaired renal function, i.e. creatinine >2.5 mg/dl
- Fever or diarrhea within 4 weeks prior screening
- History of bleeding disorder within 3 months prior screening
- Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg) or Sustained ventricular arrhythmia
- Life expectancy of less than two years from any non-cardiac cause or uncontrolled neoplastic disease
Sites / Locations
- Stem Cell And Regenerative Medicine institute (SCARM)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intracoronary injection of stem cell
Placebo
Arm Description
Autologous bone marrow-derived mononuclear cells injection in patients with Heart Failure
Placebo injection via coronary arteries in patients with Heart Failure
Outcomes
Primary Outcome Measures
Death
The rate of patients mortality after transplantation
Hospitalization
the rate of hospitalization after transplantation
Secondary Outcome Measures
Ejection fraction changes
Elevation of ejection fraction in patients after transplantation
6-minute walk test (6MWT)
Evaluation the improvement of 6MWT test after transplantation
Pro b-type natriuretic peptide (Pro-BNP) changes
Elevation the reduction of Pro-BNP in patients after transplantation
NYHA functional class
Evaluation the improvement of NYHA functional class in patients
Full Information
NCT ID
NCT03145402
First Posted
May 2, 2017
Last Updated
March 16, 2020
Sponsor
SCARM Institute, Tabriz, Iran
1. Study Identification
Unique Protocol Identification Number
NCT03145402
Brief Title
ICMNC-HF. IntraCoronary Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients
Acronym
ICMNC-HF
Official Title
The Effect of Intracoronary Autologous Bone Marrow Derived Mononuclear Stem Cell Transplantation in Heart Failure (HF) Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2020 (Anticipated)
Primary Completion Date
August 28, 2021 (Anticipated)
Study Completion Date
October 2, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SCARM Institute, Tabriz, Iran
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intracoronary injection of stem cell
Arm Type
Experimental
Arm Description
Autologous bone marrow-derived mononuclear cells injection in patients with Heart Failure
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo injection via coronary arteries in patients with Heart Failure
Intervention Type
Biological
Intervention Name(s)
Intracoronary injection of stem cell
Intervention Description
Autologous bone marrow-derived mononuclear cells are obtained from 100-150ml of bone marrow aspirated under local anaesthesia from the iliac crest. Intracoronary infusion of the cells is performed in patients with Heart failure via conventional percutaneous intracoronary intervention techniques.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Injection of Placebo in patients with Heart failure via coronary arteries
Primary Outcome Measure Information:
Title
Death
Description
The rate of patients mortality after transplantation
Time Frame
12 months
Title
Hospitalization
Description
the rate of hospitalization after transplantation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Ejection fraction changes
Description
Elevation of ejection fraction in patients after transplantation
Time Frame
12 months
Title
6-minute walk test (6MWT)
Description
Evaluation the improvement of 6MWT test after transplantation
Time Frame
12 months
Title
Pro b-type natriuretic peptide (Pro-BNP) changes
Description
Elevation the reduction of Pro-BNP in patients after transplantation
Time Frame
12 months
Title
NYHA functional class
Description
Evaluation the improvement of NYHA functional class in patients
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women of any ethnic origin 18 ≤ aged≤ 65 years
EF≤40 (by Echocardiography) and regional wall motion abnormality
Not responding to standard therapies
the New York Heart Association (NYHA) class ≥ III
Myocardial infarction due to coronary artery atherosclerotic disease
An area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or MRI)
Normal liver and renal function
No or controlled diabetes
Able to give voluntary written consent and understand the study information provided to him
Exclusion Criteria:
Participation in another clinical trial within 30 days prior randomisation
Previously received stem/progenitor cell therapy
Pregnant women
Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
Cardiogenic shock requiring mechanical support
Congenital / valvular heart disease
Implantable cardioverter defibrillator (ICD) transplant
Platelet count <100.000/µl, or hemoglobin <8.5 g/dl
Impaired renal function, i.e. creatinine >2.5 mg/dl
Fever or diarrhea within 4 weeks prior screening
History of bleeding disorder within 3 months prior screening
Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg) or Sustained ventricular arrhythmia
Life expectancy of less than two years from any non-cardiac cause or uncontrolled neoplastic disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nasser Aslanabadi, MD, Cardiologist
Phone
0413 33349525
Email
aslanabadin@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Peyman Keyhanvar, MD, Ph.D
Phone
0413 33349525
Email
drkeyhanvar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasser Aslanabadi, MD, Cardiologist
Organizational Affiliation
Tabriz University of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohammad Nouri, Ph.D
Organizational Affiliation
Head of SCARM institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Peyman Keyhanvar, MD, Ph.D
Organizational Affiliation
Deputy for translational medicine of SCARM institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raheleh Farahzadi, Ph.D
Organizational Affiliation
Cardiovascular research center, Tabriz University of Medical Sciences, Tabriz, Iran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yousef Faridvand, Ph.D
Organizational Affiliation
SCARM institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elgar Anamzadeh, MD, Cardiologist
Organizational Affiliation
Tabriz University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stem Cell And Regenerative Medicine institute (SCARM)
City
Tabriz
Country
Iran, Islamic Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peyman Keyhanvar, MD, Ph.D
Phone
0914 114 6863
First Name & Middle Initial & Last Name & Degree
Yousef Faridvand, Ph.D
12. IPD Sharing Statement
Plan to Share IPD
No
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ICMNC-HF. IntraCoronary Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients
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