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

Sponsor
SCARM Institute, Tabriz, Iran (Other)
Overall Status
Unknown status
CT.gov ID
NCT03145402
Collaborator
(none)
5
Enrollment
1
Location
2
Arms
11.4
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Intracoronary injection of stem cell
  • Biological: Placebo
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
5 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Intracoronary Autologous Bone Marrow Derived Mononuclear Stem Cell Transplantation in Heart Failure (HF) Patients
Anticipated Study Start Date :
Oct 20, 2020
Anticipated Primary Completion Date :
Aug 28, 2021
Anticipated Study Completion Date :
Oct 2, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intracoronary injection of stem cell

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

Biological: Intracoronary 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. 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

Biological: Placebo
Injection of Placebo in patients with Heart failure via coronary arteries

Outcome Measures

Primary Outcome Measures

  1. Death [12 months]

    The rate of patients mortality after transplantation

  2. Hospitalization [12 months]

    the rate of hospitalization after transplantation

Secondary Outcome Measures

  1. Ejection fraction changes [12 months]

    Elevation of ejection fraction in patients after transplantation

  2. 6-minute walk test (6MWT) [12 months]

    Evaluation the improvement of 6MWT test after transplantation

  3. Pro b-type natriuretic peptide (Pro-BNP) changes [12 months]

    Elevation the reduction of Pro-BNP in patients after transplantation

  4. NYHA functional class [12 months]

    Evaluation the improvement of NYHA functional class in patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stem Cell And Regenerative Medicine institute (SCARM) Tabriz Iran, Islamic Republic of

Sponsors and Collaborators

  • SCARM Institute, Tabriz, Iran

Investigators

  • Study Director: Nasser Aslanabadi, MD, Cardiologist, Tabriz University of Medical Sciences
  • Study Chair: Mohammad Nouri, Ph.D, Head of SCARM institute
  • Principal Investigator: Peyman Keyhanvar, MD, Ph.D, Deputy for translational medicine of SCARM institute
  • Principal Investigator: Raheleh Farahzadi, Ph.D, Cardiovascular research center, Tabriz University of Medical Sciences, Tabriz, Iran
  • Principal Investigator: Yousef Faridvand, Ph.D, SCARM institute
  • Principal Investigator: Elgar Anamzadeh, MD, Cardiologist, Tabriz University of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SCARM Institute, Tabriz, Iran
ClinicalTrials.gov Identifier:
NCT03145402
Other Study ID Numbers:
  • SCARM-Heart-001
First Posted:
May 9, 2017
Last Update Posted:
Mar 17, 2020
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Mar 17, 2020