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

NCT ID: NCT01219452

Last Updated: 2010-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dilated Cardiomyopathy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Dilated Cardiomyopathy Umbilical cord Mesenchymal stem cells Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

umbilical cord mesenchymal stem cells

intramuscular injection of umbilical cord mesenchymal stem cell

Group Type EXPERIMENTAL

umbilical cord mesenchymal stem cells

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

umbilical cord mesenchymal stem cells

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

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

mesenchymal stem cells

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Qingdao University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Organization: Stem Cell Research Center of Medical School Hospital of Qingdao University

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

zipu li, MD Phd

Role: STUDY_DIRECTOR

The Affiliated Hospital of Qingdao University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stem Cell Research Center of Medical School Hospital of Qingdao University

Qingdao, Shandong, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jianxia Hu, MD

Role: CONTACT

Phone: 86-0532-82911676

Email: [email protected]

Hong Gao, MS

Role: CONTACT

Phone: 86-0532-82911676

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jianxia Hu, MD

Role: primary

Hong Gao, MS

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MSCKX002

Identifier Type: -

Identifier Source: org_study_id