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Trial record 74 of 1813 for:    "bone marrow" | Recruiting, Not yet recruiting Studies

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

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ClinicalTrials.gov Identifier: NCT03145402
Recruitment Status : Not yet recruiting
First Posted : May 9, 2017
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heart Failure Biological: Intracoronary injection of stem cell Biological: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 20, 2019
Estimated Primary Completion Date : September 28, 2020
Estimated Study Completion Date : November 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  1. Death [ Time Frame: 12 months ]
    The rate of patients mortality after transplantation

  2. Hospitalization [ Time Frame: 12 months ]
    the rate of hospitalization after transplantation


Secondary Outcome Measures :
  1. Ejection fraction changes [ Time Frame: 12 months ]
    Elevation of ejection fraction in patients after transplantation

  2. 6-minute walk test (6MWT) [ Time Frame: 12 months ]
    Evaluation the improvement of 6MWT test after transplantation

  3. Pro b-type natriuretic peptide (Pro-BNP) changes [ Time Frame: 12 months ]
    Elevation the reduction of Pro-BNP in patients after transplantation

  4. NYHA functional class [ Time Frame: 12 months ]
    Evaluation the improvement of NYHA functional class in patients



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03145402


Contacts
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Contact: Nasser Aslanabadi, MD, Cardiologist 0413 33349525 aslanabadin@yahoo.com
Contact: Peyman Keyhanvar, MD, Ph.D 0413 33349525 drkeyhanvar@gmail.com

Locations
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Iran, Islamic Republic of
Stem Cell And Regenerative Medicine institute (SCARM) Not yet recruiting
Tabriz, Iran, Islamic Republic of
Contact: Peyman Keyhanvar, MD, Ph.D    0914 114 6863      
Principal Investigator: Yousef Faridvand, Ph.D         
Sponsors and Collaborators
SCARM Institute, Tabriz, Iran
Investigators
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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

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Responsible Party: SCARM Institute, Tabriz, Iran
ClinicalTrials.gov Identifier: NCT03145402     History of Changes
Other Study ID Numbers: SCARM-Heart-001
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases