Heart Failure
Conditions
Brief 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.
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)
Sponsors
SCARM Institute, Tabriz, Iran
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization | 12 months | the rate of hospitalization after transplantation |
| Death | 12 months | The rate of patients mortality after transplantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ejection fraction changes | 12 months | Elevation of ejection fraction in patients after transplantation |
| 6-minute walk test (6MWT) | 12 months | Evaluation the improvement of 6MWT test after transplantation |
| Pro b-type natriuretic peptide (Pro-BNP) changes | 12 months | Elevation the reduction of Pro-BNP in patients after transplantation |
| NYHA functional class | 12 months | Evaluation the improvement of NYHA functional class in patients |
Countries
Iran
Contacts
Primary ContactNasser Safaie, CTS
Backup ContactPeyman Keyhanvar, MD, Ph.D
Outcome results
None listed