Clinical trial NCT03145402: ICMNC-HF. IntraCoronary Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients
Official title: The Effect of Intracoronary Autologous Bone Marrow Derived Mononuclear Stem Cell Transplantation in Heart Failure (HF) Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Heart Failure
Lead sponsor: SCARM Institute, Tabriz, Iran
Sponsor class: OTHER_GOV
First posted: 2017-05-09
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Death
timeFrame: 12 months
measure: Hospitalization
timeFrame: 12 months
Secondary outcomes:
measure: Ejection fraction changes
timeFrame: 12 months
measure: 6-minute walk test (6MWT)
timeFrame: 12 months
measure: Pro b-type natriuretic peptide (Pro-BNP) changes
timeFrame: 12 months
measure: NYHA functional class
timeFrame: 12 months
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Stem Cell And Regenerative Medicine institute (SCARM)
Study officials:
affiliation: Tabriz University of Medical Sciences
name: Nasser Aslanabadi, MD, Cardiologist
role: STUDY_DIRECTOR
affiliation: Head of SCARM institute
name: Mohammad Nouri, Ph.D
role: STUDY_CHAIR
affiliation: Deputy for translational medicine of SCARM institute
name: Peyman Keyhanvar, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiovascular research center, Tabriz University of Medical Sciences, Tabriz, Iran
name: Raheleh Farahzadi, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: SCARM institute
name: Yousef Faridvand, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Tabriz University of Medical Sciences
name: Elgar Anamzadeh, MD, Cardiologist
role: PRINCIPAL_INVESTIGATOR
References: