Intramuscular Injection of Mesenchymal Stem Cell for Treatment of Children With Idiopathic Dilated Cardiomyopathy
Effects of Intramuscular Injection of Umbilical Cord Mesenchymal Stem Cell on the Ventricular Function of Children With Idiopathic Dilated Cardiomyopathy
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2010
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 12, 2010
CompletedFirst Posted
Study publicly available on registry
October 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedOctober 28, 2010
May 1, 2010
2.1 years
October 12, 2010
October 27, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
echocardiography
3 months
Secondary Outcomes (3)
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
Study Arms (1)
umbilical cord mesenchymal stem cells
EXPERIMENTALintramuscular injection of umbilical cord mesenchymal stem cell
Interventions
Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.
Eligibility Criteria
You may qualify if:
- 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%.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stem Cell Research Center of Medical School Hospital of Qingdao University
Qingdao, Shandong, 266003, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
zipu li, MD Phd
The Affiliated Hospital of Qingdao University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 12, 2010
First Posted
October 13, 2010
Study Start
October 1, 2010
Primary Completion
November 1, 2012
Study Completion
December 1, 2012
Last Updated
October 28, 2010
Record last verified: 2010-05