- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03145402
ICMNC-HF. IntraCoronary Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients (ICMNC-HF)
March 16, 2020 updated by: SCARM Institute, Tabriz, Iran
The Effect of Intracoronary Autologous Bone Marrow Derived Mononuclear Stem Cell Transplantation 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 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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
5
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nasser Aslanabadi, MD, Cardiologist
- Phone Number: 0413 33349525
- Email: aslanabadin@yahoo.com
Study Locations
-
-
-
Tabriz, Iran, Islamic Republic of
- Stem Cell And Regenerative Medicine institute (SCARM)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intracoronary injection of stem cell
Autologous bone marrow-derived mononuclear cells injection in patients with Heart Failure
|
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.
|
Placebo Comparator: Placebo
Placebo injection via coronary arteries in patients with Heart Failure
|
Injection of Placebo in patients with Heart failure via coronary arteries
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Death
Time Frame: 12 months
|
The rate of patients mortality after transplantation
|
12 months
|
Hospitalization
Time Frame: 12 months
|
the rate of hospitalization after transplantation
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ejection fraction changes
Time Frame: 12 months
|
Elevation of ejection fraction in patients after transplantation
|
12 months
|
6-minute walk test (6MWT)
Time Frame: 12 months
|
Evaluation the improvement of 6MWT test after transplantation
|
12 months
|
Pro b-type natriuretic peptide (Pro-BNP) changes
Time Frame: 12 months
|
Elevation the reduction of Pro-BNP in patients after transplantation
|
12 months
|
NYHA functional class
Time Frame: 12 months
|
Evaluation the improvement of NYHA functional class in patients
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nasser Aslanabadi, MD, Cardiologist, Tabriz University of Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 20, 2020
Primary Completion (Anticipated)
August 28, 2021
Study Completion (Anticipated)
October 2, 2021
Study Registration Dates
First Submitted
May 2, 2017
First Submitted That Met QC Criteria
May 4, 2017
First Posted (Actual)
May 9, 2017
Study Record Updates
Last Update Posted (Actual)
March 17, 2020
Last Update Submitted That Met QC Criteria
March 16, 2020
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCARM-Heart-001
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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