IMMNC-HF: IntraMyocardial Injection of Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients
NCT ID: NCT03227198
Last Updated: 2020-10-27
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
5 participants
INTERVENTIONAL
2020-10-14
2021-10-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intramyocardial injection of stem cell
Intramyocardial injection of autologous bone marrow mononuclear cells in patients with Heart Failure
Intramyocardial 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)
Placebo
Placebo intramyocardial injection in patients with Heart Failure
Placebo
Injection of Placebo in patients with Heart failure in open heart surgery (CABG)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intramyocardial 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)
Placebo
Injection of Placebo in patients with Heart failure in open heart surgery (CABG)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
Meet the organizations funding or collaborating on the study and learn about their roles.
SCARM Institute, Tabriz, Iran
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nasser Safaie, CTS
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
Explore where the study is taking place and check the recruitment status at each participating site.
Stem Cell And Regenerative Medicine institute (SCARM)
Tabriz, , Iran
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Peyman Keyhanvar, MD, Ph.D
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SCARM-Heart-002
Identifier Type: -
Identifier Source: org_study_id