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Status unknownNCT03227198IMMNC-HFUpdated Oct 27, 2020

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

A Phase 1/2 interventional study of Intramyocardial injection of stem cell and Placebo in Heart Failure, sponsored by SCARM Institute, Tabriz, Iran. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-10-27.

Sponsored by SCARM Institute, Tabriz, Iran · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
5
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Heart Failure

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03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
5 participants (estimated)

Study arms

  • 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

  • Placebo comparator
    Placebo

    Placebo intramyocardial injection in patients with Heart Failure

    Biological: Placebo

Interventions

  • BiologicalIntramyocardial 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)

  • BiologicalPlacebo

    Injection of Placebo in patients with Heart failure in open heart surgery (CABG)

05

What researchers measure

Primary outcomes

  1. Death

    The rate of patients mortality after transplantation

    Time frame: 12 months

  2. Hospitalization

    the rate of hospitalization after transplantation

    Time frame: 12 months

Secondary outcomes

  1. Ejection fraction changes

    Elevation of ejection fraction in patients after transplantation

    Time frame: 12 months

  2. 6-minute walk test (6MWT)

    Evaluation the improvement of 6MWT test after transplantation

    Time frame: 12 months

  3. Pro b-type natriuretic peptide (Pro-BNP) changes

    Elevation the reduction of Pro-BNP in patients after transplantation

    Time frame: 12 months

  4. NYHA functional class

    Evaluation the improvement of NYHA functional class in patients

    Time frame: 12 months

06

Study locations

1 site
  • Stem Cell And Regenerative Medicine institute (SCARM)
    Tabriz, Iran, Islamic Republic of
    • Peyman Keyhanvar, MD, Ph.D · Contact · 0914 114 6863
    • Yousef Faridvand, Ph.D · Principal investigator
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03227198
Lead sponsor
SCARM Institute, Tabriz, Iran
Responsible party
Sponsor
First posted
Jul 24, 2017
Start date
Oct 14, 2020 (estimated)
Primary completion
Aug 10, 2021 (estimated)
Completion
Oct 12, 2021 (estimated)
Last update
Oct 27, 2020

Study contacts

Nasser Safaie, CTS
Contact
drsafaie@yahoo.com
0413 33349525
Peyman Keyhanvar, MD, Ph.D
Contact
drkeyhanvar@gmail.com
0413 33349525
Nasser Safaie, CTS
study director · Tabriz University of Medical Sciences
Mohammad Nouri, Ph.D
study chair · Head of SCARM institute
Peyman Keyhanvar, MD, Ph.D
principal investigator · Deputy for translational medicine of SCARM institute
Raheleh Farahzadi, Ph.D
principal investigator · Cardiovascular research center, Tabriz University of Medical Sciences, Tabriz, Iran
Yousef Faridvand, Ph.D
principal investigator · SCARM institute
Elgar Anamzadeh, MD, Cardiologist
principal investigator · Tabriz University of Medical Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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