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

S

SCARM Institute, Tabriz, Iran

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Heart Failure

Treatments

Biological: Placebo
Biological: Intramyocardial injection of stem cell

Study type

Interventional

Funder types

Other

Identifiers

NCT03227198
SCARM-Heart-002

Details and patient eligibility

About

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.

Enrollment

5 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

5 participants in 2 patient groups, including a placebo group

Intramyocardial injection of stem cell
Experimental group
Description:
Intramyocardial injection of autologous bone marrow mononuclear cells in patients with Heart Failure
Treatment:
Biological: Intramyocardial injection of stem cell
Placebo
Placebo Comparator group
Description:
Placebo intramyocardial injection in patients with Heart Failure
Treatment:
Biological: Placebo

Trial contacts and locations

1

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Central trial contact

Peyman Keyhanvar, MD, Ph.D; Nasser Safaie, CTS

Data sourced from clinicaltrials.gov

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