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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Qingdao University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Qingdao University
ClinicalTrials.gov Identifier:
NCT01219452
First received: October 12, 2010
Last updated: October 27, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Dilated Cardiomyopathy
Biological: umbilical cord mesenchymal stem cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Intramuscular Injection of Umbilical Cord Mesenchymal Stem Cell on the Ventricular Function of Children With Idiopathic Dilated Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by Qingdao University:

Primary Outcome Measures:
  • echocardiography [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 24h HOLTER [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • The level of serum BNP,TNI,HGF、LIF and G/M-CSF [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • The expression level of c-kit,CD31,CD133 on peripheral blood mononuclear cells [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: umbilical cord mesenchymal stem cells
intramuscular injection of umbilical cord mesenchymal stem cell
Biological: umbilical cord mesenchymal stem cells
Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.
Other Name: mesenchymal stem cells

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.

  Eligibility

Ages Eligible for Study:   1 Year to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219452

Contacts
Contact: Jianxia Hu, MD 86-0532-82911676 qdyxyhjx@126.com
Contact: Hong Gao, MS 86-0532-82911676 honggaogloria@gmail.com

Locations
China, Shandong
Stem Cell Research Center of Medical School Hospital of Qingdao University Not yet recruiting
Qingdao, Shandong, China, 266003
Contact: Jianxia Hu, MD    86-0532-82911676    qdyxyhjx@126.com   
Contact: Hong Gao, MS    86-0532-82911676    honggaogloria@gmail.com   
Principal Investigator: Zipu Li, MD PhD         
Sub-Investigator: Pin Sun, MD         
Sub-Investigator: Nana Nie, MS         
Sponsors and Collaborators
Qingdao University
Investigators
Study Director: zipu li, MD Phd The Affiliated Hospital of Medical College of Qingdao University
  More Information

No publications provided

Responsible Party: Qingdao University, Organization: Stem Cell Research Center of Medical School Hospital of Qingdao University
ClinicalTrials.gov Identifier: NCT01219452     History of Changes
Other Study ID Numbers: MSCKX002
Study First Received: October 12, 2010
Last Updated: October 27, 2010
Health Authority: China: Ministry of Health

Keywords provided by Qingdao University:
Dilated Cardiomyopathy
Umbilical cord
Mesenchymal stem cells
Children

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Cardiomyopathies
Cardiomegaly
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014