Back to resultsIntramuscular Injection of Mesenchymal Stem Cell for Treatment of Children With Idiopathic Dilated Cardiomyopathy
Primary Purpose
Dilated Cardiomyopathy
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
umbilical cord mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Dilated Cardiomyopathy focused on measuring Dilated Cardiomyopathy, Umbilical cord, Mesenchymal stem cells, Children
Eligibility Criteria
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.
Sites / Locations
- Stem Cell Research Center of Medical School Hospital of Qingdao University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
umbilical cord mesenchymal stem cells
Arm Description
intramuscular injection of umbilical cord mesenchymal stem cell
Outcomes
Primary Outcome Measures
echocardiography
Secondary Outcome Measures
24h HOLTER
The level of serum BNP,TNI,HGF、LIF and G/M-CSF
The expression level of c-kit,CD31,CD133 on peripheral blood mononuclear cells
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01219452
Brief Title
Intramuscular Injection of Mesenchymal Stem Cell for Treatment of Children With Idiopathic Dilated Cardiomyopathy
Official Title
Effects of Intramuscular Injection of Umbilical Cord Mesenchymal Stem Cell on the Ventricular Function of Children With Idiopathic Dilated Cardiomyopathy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Qingdao University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dilated Cardiomyopathy
Keywords
Dilated Cardiomyopathy, Umbilical cord, Mesenchymal stem cells, Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
umbilical cord mesenchymal stem cells
Arm Type
Experimental
Arm Description
intramuscular injection of umbilical cord mesenchymal stem cell
Intervention Type
Biological
Intervention Name(s)
umbilical cord mesenchymal stem cells
Other Intervention Name(s)
mesenchymal stem cells
Intervention Description
Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.
Primary Outcome Measure Information:
Title
echocardiography
Time Frame
3 months
Secondary Outcome Measure Information:
Title
24h HOLTER
Time Frame
2 months
Title
The level of serum BNP,TNI,HGF、LIF and G/M-CSF
Time Frame
3 months
Title
The expression level of c-kit,CD31,CD133 on peripheral blood mononuclear cells
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianxia Hu, MD
Phone
86-0532-82911676
Email
qdyxyhjx@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Gao, MS
Phone
86-0532-82911676
Email
honggaogloria@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zipu li, MD Phd
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Study Director
Facility Information:
Facility Name
Stem Cell Research Center of Medical School Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianxia Hu, MD
Phone
86-0532-82911676
Email
qdyxyhjx@126.com
First Name & Middle Initial & Last Name & Degree
Hong Gao, MS
Phone
86-0532-82911676
Email
honggaogloria@gmail.com
First Name & Middle Initial & Last Name & Degree
Zipu Li, MD PhD
First Name & Middle Initial & Last Name & Degree
Pin Sun, MD
First Name & Middle Initial & Last Name & Degree
Nana Nie, MS
12. IPD Sharing Statement
Learn more about this trial
Intramuscular Injection of Mesenchymal Stem Cell for Treatment of Children With Idiopathic Dilated Cardiomyopathy
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