Safety Assessment of Intracoronary Transplantation of Autologous Bone Marrow Derived Mononuclear Cells in Pediatric with Dilated Cardiomyopathy in Comparison with Control Group: Clinical Trial Phase I/II
A controlled, parallel, randomized, open label clinical trial, phase I/II on 24 patients
Settings and conduct
Location: Royan Institute and Rajaie Cardiovascular, Medical and Research Center
After enrollment, patients are randomly divided into 2 groups of cell and control. only patients which in cell group undergo bone marrow biopsy and their bone marrow-derived mononuclear cells (MNCs) are isolated and transferred to the relevant hospital in special containers and under sterile conditions and are used for injection into the coronary arteries. Patients in both groups are followed up at specific times and the data are evaluated using software.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 1-16 year (s)
Both sex
LVEF<45% (echocardiography)
Time of Diagnosis > 3m
Resistance to Standard therapy > 1m (Dig, ACEi, Diuretic, BB)
Informed consent
Exclusion criteria:
Congenital heart disease
Active infection less than one month
Dysrhythmia
Cardiogenic shock
Renal failure
Intervention groups
1- Recipient group of autologous bone marrow derived mononuclear cells
2- Control group (with no intervention)
Main outcome variables
Adverse events
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080728001031N27
Registration date:2021-01-10, 1399/10/21
Registration timing:retrospective
Last update:2021-01-10, 1399/10/21
Update count:0
Registration date
2021-01-10, 1399/10/21
Registrant information
Name
Nasser Aghdami
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2000
Email address
nasser.aghdami@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-05-01, 1392/02/11
Expected recruitment end date
2016-03-29, 1395/01/10
Actual recruitment start date
2014-10-01, 1393/07/09
Actual recruitment end date
2016-12-29, 1395/10/09
Trial completion date
2018-03-20, 1396/12/29
Scientific title
Safety Assessment of Intracoronary Transplantation of Autologous Bone Marrow Derived Mononuclear Cells in Pediatric with Dilated Cardiomyopathy in Comparison with Control Group: Clinical Trial Phase I/II
Public title
Effect of bone marrow derived mononuclear cells in treatment of pediatric with cardiomyopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
LVEF<45% (echocardiography)
Time of Diagnosis > 3m
Resistance to Standard therapy > 1m (Dig, ACE, Diuretic, BB)
Exclusion criteria:
Critical aortic stenosis
Severe coarctation
Coronary artery anomalies
Cardiogenic shock
Age
From 1 year old to 16 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table was provided by statistician using randomization website (block randomization with block size of 4) according to individual unit and allocation was performed by a third party which is not directly connected with the clinical trial.
Intervention group: This group underwent bone marrow aspiration in amount of 2 cc/kg. This sample transfers to clean room of Royan institute for mononuclear cells processing. Then, patients underwent coronary angiography in lass than 6 hours and theses cells which are suspended in 10 cc of normal saline will be infused intracoronary.
Category
Treatment - Other
2
Description
Control group: This group do not underwent bone marrow aspiration and do not receive placebo. So, they are as a comparison group.