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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01219452

Enrollment

Registered

2010-10-13

Start date

2010-10-31

Completion date

2012-12-31

Last updated

2010-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dilated Cardiomyopathy

Keywords

Dilated Cardiomyopathy, Umbilical cord, Mesenchymal stem cells, Children

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.

Interventions

BIOLOGICALumbilical cord mesenchymal stem cells

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 14 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
echocardiography	3 months

Secondary

Measure	Time frame
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

Countries

China

Contacts

Primary ContactJianxia Hu, MD

qdyxyhjx@126.com86-0532-82911676

Backup ContactHong Gao, MS

honggaogloria@gmail.com86-0532-82911676

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026