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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01219452
Other study ID # MSCKX002
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received October 12, 2010
Last updated October 27, 2010
Start date October 2010
Est. completion date December 2012

Study information

Verified date May 2010
Source Qingdao University
Contact Jianxia Hu, MD
Phone 86-0532-82911676
Email qdyxyhjx@126.com
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 14 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Biological:
umbilical cord mesenchymal stem cells
Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.

Locations

Country Name City State
China Stem Cell Research Center of Medical School Hospital of Qingdao University Qingdao Shandong

Sponsors (1)

Lead Sponsor Collaborator
Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary echocardiography 3 months No
Secondary 24h HOLTER 2 months No
Secondary The level of serum BNP,TNI,HGF?LIF and G/M-CSF 3 months No
Secondary The expression level of c-kit,CD31,CD133 on peripheral blood mononuclear cells 2 months No
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