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Status unknownNCT01219452Updated Oct 28, 2010

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

A Phase 1/2 interventional study of umbilical cord mesenchymal stem cells in Dilated Cardiomyopathy, sponsored by Qingdao University. Status unknown at 1 site in China. Open to participants aged 1 Year to 14 Years. Per ClinicalTrials.gov, last updated 2010-10-28.

Sponsored by Qingdao University · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2010), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
1 Year to 14 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dilated Cardiomyopathy

Keywords

  • Dilated Cardiomyopathy
  • Umbilical cord
  • Mesenchymal stem cells
  • Children
03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's planned enrollment of 30 is below the median of 51 across 609 interventional studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

Qingdao University is the lead sponsor of 22 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    umbilical cord mesenchymal stem cells

    intramuscular injection of umbilical cord mesenchymal stem cell

    Biological: umbilical cord mesenchymal stem cells

Interventions

  • Biologicalumbilical cord mesenchymal stem cells

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

    Also known as: mesenchymal stem cells

06

What researchers measure

Primary outcomes

  1. echocardiography

    Time frame: 3 months

Secondary outcomes

  1. 24h HOLTER

    Time frame: 2 months

  2. The level of serum BNP,TNI,HGF、LIF and G/M-CSF

    Time frame: 3 months

  3. The expression level of c-kit,CD31,CD133 on peripheral blood mononuclear cells

    Time frame: 2 months

07

Study locations

1 site
  • Stem Cell Research Center of Medical School Hospital of Qingdao University
    Qingdao, Shandong 266003, China
    • Jianxia Hu, MD · Contact · qdyxyhjx@126.com · 86-0532-82911676
    • Hong Gao, MS · Contact · honggaogloria@gmail.com · 86-0532-82911676
    • Zipu Li, MD PhD · Principal investigator
    • Pin Sun, MD · Sub investigator
    • Nana Nie, MS · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01219452
Lead sponsor
Qingdao University
First posted
Oct 13, 2010
Start date
Oct 2010
Primary completion
Nov 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Oct 28, 2010

Study contacts

Jianxia Hu, MD
Contact
qdyxyhjx@126.com
86-0532-82911676
Hong Gao, MS
Contact
honggaogloria@gmail.com
86-0532-82911676
zipu li, MD Phd
study director · The Affiliated Hospital of Qingdao University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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