NCT01219452UnknownPhase 1
Effects of Intramuscular Injection of Umbilical Cord Mesenchymal Stem Cell on the Ventricular Function of Children With Idiopathic Dilated Cardiomyopathy
Qingdao University1 site in 1 country30 target enrollmentStarted: October 1, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- echocardiography
Study Overview
Brief Summary
The main aim of the study is to determine whether intramuscular injection of umbilical cord mesenchymal stem cells can improve the ventricular function of children with idiopathic dilated cardiomyopathy(IDCM); Secondary end-points will be: 1)To explore the possible mechanism of the improvement of ventricular function in children with IDCM and 2) to evaluate the safety of intramuscular injection of umbilical cord mesenchymal stem cell.
Detailed Description
Children with Idiopathic dilated cardiomyopathy class II to III NYHA with ejection fraction over 20% were selected for phase II clinical trial, umbilical cord mesenchymal stem cells were injected into limb muscle and followed for 6 months.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children of both genders with established clinical and echocardiographic diagnosis of dilated cardiomyopathy whose parents accept to participate in the trail.
- •They should have symptoms and /or signs of heart failure, despite optimized medical treatment.
- •Ejection fraction of left ventricular should be less than 50%, but more than 20%.
Exclusion Criteria
- •associate coronary artery disease.
- •any history or suspicion of a toxic , pharmacologic or deposit etiology.
- •associated malignant or pre -malignant systemic disease.
- •associated hematologic disorder.
- •a history of sustained ventricular tachycardia or fibrillation.
- •a history of syncope during the previous year, or with an active infectious disease or positive tests to viral disease.
Outcomes
Primary Outcomes
echocardiography
Time Frame: 3 months
Secondary Outcomes
- 24h HOLTER(2 months)
- The level of serum BNP,TNI,HGF、LIF and G/M-CSF(3 months)
- The expression level of c-kit,CD31,CD133 on peripheral blood mononuclear cells(2 months)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 4
The Effect of Intralesian Injection of Umbilical Cord Mesenchymal Stem Cells, Its Conditioned Medium, and Triamcinolone Acetonide on Type 1:3 Collagen Ratio and Interleukin-10 Levels in Keloid: A Randomised Controlled TrialKeloidStem CellNCT05939817Rumah Sakit Pusat Angkatan Darat Gatot Soebroto24
Completed
Phase 2
The effect of dexamethasone injection in infants with acute bronchiolitisAcute bronchiolitis.Acute bronchitis, unspecifiedIRCT2014120218974N2Vice chancellor for research, Kermanshah University of Medical Sciences80
Completed
Phase 3
Evaluation of the injection of umbilical cord-derived stem cells and platelet-rich plasma in patients with resistant lateral epicondylitis in patients referred to the super-specialized orthopedic clinic of Imam Khomeini Hospital in SariMedial epicondylitis.Medial epicondylitisM77.0IRCT20231206060276N1Mazandaran University of Medical Sciences24
Completed
Phase 1
Multi-intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Heart Failure With Reduced Ejection Fraction（PRIME-HFrEF Study）Heart Failure, SystolicNCT04992832Shanghai East Hospital40
Not yet recruiting
Phase 3
Umbilical Cord Mesenchymal Stem Cell Improve Cardiac Function on ST-elevation Myocardial Infarction (STEMI) PatientsST Elevation Myocardial InfarctionNCT05935423Indonesia University60