Safety Assessment of Intracoronary Transplantation of Wharton's Jelly Derived-Mesenchymal Stem Cells in Pediatric with Non-Ischemic Dilated Cardiomyopathy: Clinical Trial Phase I
uncontrolled, single arm, unblinded, not randomized clinical trial phase I on 5 patients
Settings and conduct
Location: Children’s Medical Center and Royan Institute
In this study, 5 eligible patients with dilated cardiomyopathy due to viral myocarditis underwent single intracoronary infusion of (1.5×106/Kg) wharton's jelly derived-mesenchymal stem cells which are suspended in 5- 10 cc normal saline. Theses cells provide from a GMP certified bank. The patients will transfer to ICU or CCU. Then, they follow up at defined timepoints (1 week, 1,3,6,9 and 12 moths) and data will be documented and analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-Age 4-12 y
2-Both sex
3-20% <LVEF<35% (echocardiography)
4- Time of Diagnosis > 1 y
5-Candidate for heart transplantation
6-Heart failure due to idiopathic and acute viral myocarditis
7-NYHA function class II/III
Exclusion criteria:
1-Critical aortic stenosis
2- Severe coarctation
3- Coronary artery anomalies
4- Cardiogenic shock
Intervention groups
Interventional group: The group receive single intracoronary infusion of (1.5×106/Kg) of wharton's jelly derived-mesenchymal stem cells which is suspended in 5-10 cc normal saline.
This study has no control group.
Main outcome variables
Assessment of frequency of adverse event; Assessment of feasibility; Blood test of ProBNP measurement;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201217049743N1
Registration date:2021-01-29, 1399/11/10
Registration timing:prospective
Last update:2021-01-29, 1399/11/10
Update count:0
Registration date
2021-01-29, 1399/11/10
Registrant information
Name
Aliakbar Zeinaloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6147 9000
Email address
zeinaloo@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety Assessment of Intracoronary Transplantation of Wharton's Jelly Derived-Mesenchymal Stem Cells in Pediatric with Non-Ischemic Dilated Cardiomyopathy: Clinical Trial Phase I
Public title
Effect of wharton's jelly derived-mesenchymal stem cells in treatment of pediatric with cardiomyopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20% <LVEF<35% (echocardiography)
Time of Diagnosis > 1 y
Candidate for heart transplantation
Heart failure due to idiopathic and acute viral myocarditis
NYHA function class II/III
Exclusion criteria:
Critical aortic stenosis
Severe coarctation
Coronary artery anomalies
Cardiogenic shock
Age
From 4 years old to 12 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university of medical sciences
Street address
Headquarters of Tehran University of Medical Sciences, Corner of Ghods St., Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-12-13, 1399/09/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.896
Health conditions studied
1
Description of health condition studied
Viral cardiomyopathy
ICD-10 code
B33.24
ICD-10 code description
Viral cardiomyopathy
Primary outcomes
1
Description
Assessment of safety
Timepoint
Base and 1 week, 1,3,6,9 months after transplantation
Method of measurement
Physical examination and clinical symptom
2
Description
Assessment of tolerability
Timepoint
Base and 1 week, 1,3,6,9 months after transplantation
Method of measurement
Physical examination and clinical symptom
Secondary outcomes
1
Description
ProBNP measurement
Timepoint
Base, 1, 3, 6, 9 and 12 months after transplantation
Method of measurement
Lab test
Intervention groups
1
Description
Intervention group: Wharton's jelly derived-mesenchymal stem cells receive from a GMP certified bank in Celltech pharmed Co. Then, patients underwent coronary angiography and theses cells which are suspended in 5-10 cc of normal saline will be infused intracoronary.