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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
5
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)
Stem Cell And Regenerative Medicine institute (SCARM)
Tabriz, Iran
Death
The rate of patients mortality after transplantation
Time frame: 12 months
Hospitalization
the rate of hospitalization after transplantation
Time frame: 12 months
Ejection fraction changes
Elevation of ejection fraction in patients after transplantation
Time frame: 12 months
6-minute walk test (6MWT)
Evaluation the improvement of 6MWT test after transplantation
Time frame: 12 months
Pro b-type natriuretic peptide (Pro-BNP) changes
Elevation the reduction of Pro-BNP in patients after transplantation
Time frame: 12 months
NYHA functional class
Evaluation the improvement of NYHA functional class in patients
Time frame: 12 months
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