Status:
UNKNOWN
IMMNC-HF: IntraMyocardial Injection of Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients
Lead Sponsor:
SCARM Institute, Tabriz, Iran
Conditions:
Heart Failure
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Men and women of any ethnic origin 18 ≤ aged≤ 65 years
- EF≤40 (by Echocardiography) and regional wall motion abnormality
- Not responding to standard therapies
- the New York Heart Association (NYHA) class ≥ III
- Myocardial infarction due to coronary artery atherosclerotic disease
- An area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or MRI)
- Normal liver and renal function
- No or controlled diabetes
- Able to give voluntary written consent and understand the study information provided to him
Exclusion
- Participation in another clinical trial within 30 days prior randomisation
- Previously received stem/progenitor cell therapy
- Pregnant women
- Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
- Cardiogenic shock requiring mechanical support
- Congenital / valvular heart disease
- Implantable cardioverter defibrillator (ICD) transplant
- Platelet count \<100.000/µl, or hemoglobin \<8.5 g/dl
- Impaired renal function, i.e. creatinine \>2.5 mg/dl
- Fever or diarrhea within 4 weeks prior screening
- History of bleeding disorder within 3 months prior screening
- Uncontrolled hypertension (systolic \>180 mmHg and diastolic \>120 mmHg) or Sustained ventricular arrhythmia
- Life expectancy of less than two years from any non-cardiac cause or uncontrolled neoplastic disease
Key Trial Info
Start Date :
October 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 12 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03227198
Start Date
October 14 2020
End Date
October 12 2021
Last Update
October 27 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stem Cell And Regenerative Medicine institute (SCARM)
Tabriz, Iran