IMMNC-HF: IntraMyocardial Injection of Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients
IMMNC-HF
Evaluation of the Intramyocardial Injection of Autologous Bone Marrow Derived Mononuclear Stem Cells in Heart Failure (HF) Patients
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 heart-failure
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2017
CompletedFirst Posted
Study publicly available on registry
July 24, 2017
CompletedStudy Start
First participant enrolled
October 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2021
CompletedOctober 27, 2020
August 1, 2020
10 months
July 21, 2017
October 24, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Death
The rate of patients mortality after transplantation
12 months
Hospitalization
the rate of hospitalization after transplantation
12 months
Secondary Outcomes (4)
Ejection fraction changes
12 months
6-minute walk test (6MWT)
12 months
Pro b-type natriuretic peptide (Pro-BNP) changes
12 months
NYHA functional class
12 months
Study Arms (2)
Intramyocardial injection of stem cell
EXPERIMENTALIntramyocardial injection of autologous bone marrow mononuclear cells in patients with Heart Failure
Placebo
PLACEBO COMPARATORPlacebo intramyocardial injection in patients with Heart Failure
Interventions
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)
Injection of Placebo in patients with Heart failure in open heart surgery (CABG)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stem Cell And Regenerative Medicine institute (SCARM)
Tabriz, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nasser Safaie, CTS
Tabriz University of Medical Sciences
- STUDY CHAIR
Mohammad Nouri, Ph.D
Head of SCARM institute
- PRINCIPAL INVESTIGATOR
Peyman Keyhanvar, MD, Ph.D
Deputy for translational medicine of SCARM institute
- PRINCIPAL INVESTIGATOR
Raheleh Farahzadi, Ph.D
Cardiovascular research center, Tabriz University of Medical Sciences, Tabriz, Iran
- PRINCIPAL INVESTIGATOR
Yousef Faridvand, Ph.D
SCARM institute
- PRINCIPAL INVESTIGATOR
Elgar Anamzadeh, MD, Cardiologist
Tabriz University of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2017
First Posted
July 24, 2017
Study Start
October 14, 2020
Primary Completion
August 10, 2021
Study Completion
October 12, 2021
Last Updated
October 27, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share