Intramuscular Injection of Mesenchymal Stem Cell for Treatment of Children With Idiopathic Dilated Cardiomyopathy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01219452
• Date of registration: 12/10/2010
• Prospective Registration: No
• Primary sponsor: Qingdao University
• Public title: Intramuscular Injection of Mesenchymal Stem Cell for Treatment of Children With Idiopathic Dilated Cardiomyopathy
• Scientific title: Effects of Intramuscular Injection of Umbilical Cord Mesenchymal Stem Cell on the Ventricular Function of Children With Idiopathic Dilated Cardiomyopathy
• Date of first enrolment: October 2010
• Target sample size: 30
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01219452
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

China

Contacts

• Name: Jianxia Hu, MD

• Name: Jianxia Hu, MD

• Name: zipu li, MD Phd
• Affiliation: The Affiliated Hospital of Medical College of Qingdao University

Key inclusion & exclusion 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.



Age minimum: 1 Year
Age maximum: 14 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Dilated Cardiomyopathy

Intervention(s)

Biological: umbilical cord mesenchymal stem cells

Primary Outcome(s)

echocardiography [Time Frame: 3 months]

Secondary Outcome(s)

24h HOLTER [Time Frame: 2 months]

The expression level of c-kit,CD31,CD133 on peripheral blood mononuclear cells [Time Frame: 2 months]

The level of serum BNP,TNI,HGF?LIF and G/M-CSF [Time Frame: 3 months]

Secondary ID(s)

MSCKX002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors