ICMNC-HF. IntraCoronary Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients
NCT ID: NCT03145402
Last Updated: 2020-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
5 participants
INTERVENTIONAL
2020-10-20
2021-10-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intracoronary injection of stem cell
Autologous bone marrow-derived mononuclear cells injection in patients with Heart Failure
Intracoronary 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. Intracoronary infusion of the cells is performed in patients with Heart failure via conventional percutaneous intracoronary intervention techniques.
Placebo
Placebo injection via coronary arteries in patients with Heart Failure
Placebo
Injection of Placebo in patients with Heart failure via coronary arteries
Interventions
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Intracoronary 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. Intracoronary infusion of the cells is performed in patients with Heart failure via conventional percutaneous intracoronary intervention techniques.
Placebo
Injection of Placebo in patients with Heart failure via coronary arteries
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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SCARM Institute, Tabriz, Iran
OTHER_GOV
Responsible Party
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Principal Investigators
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Nasser Aslanabadi, MD, Cardiologist
Role: STUDY_DIRECTOR
Tabriz University of Medical Sciences
Mohammad Nouri, Ph.D
Role: STUDY_CHAIR
Head of SCARM institute
Peyman Keyhanvar, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Deputy for translational medicine of SCARM institute
Raheleh Farahzadi, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular research center, Tabriz University of Medical Sciences, Tabriz, Iran
Yousef Faridvand, Ph.D
Role: PRINCIPAL_INVESTIGATOR
SCARM institute
Elgar Anamzadeh, MD, Cardiologist
Role: PRINCIPAL_INVESTIGATOR
Tabriz University of Medical Sciences
Locations
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Stem Cell And Regenerative Medicine institute (SCARM)
Tabriz, , Iran
Countries
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Central Contacts
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Facility Contacts
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Peyman Keyhanvar, MD, Ph.D
Role: primary
Other Identifiers
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SCARM-Heart-001
Identifier Type: -
Identifier Source: org_study_id
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