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IMMNC-HF: IntraMyocardial Injection of Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients

NCT03227198 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-10-27

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

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)

BIOLOGICAL

Placebo

Injection of Placebo in patients with Heart failure in open heart surgery (CABG)

Sponsors & Collaborators

  • SCARM Institute, Tabriz, Iran

    lead OTHER_GOV

Principal Investigators

  • Nasser Safaie, CTS · Tabriz University of Medical Sciences

  • Mohammad Nouri, Ph.D · Head of SCARM institute

  • Peyman Keyhanvar, MD, Ph.D · Deputy for translational medicine of SCARM institute

  • Raheleh Farahzadi, Ph.D · Cardiovascular research center, Tabriz University of Medical Sciences, Tabriz, Iran

  • Yousef Faridvand, Ph.D · SCARM institute

  • Elgar Anamzadeh, MD, Cardiologist · Tabriz University of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-14
Primary Completion
2021-08-10
Completion
2021-10-12

Countries

  • Iran

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03227198 on ClinicalTrials.gov