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Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Duchenne Muscular Dystrophy

NCT ID: NCT01610440

Last Updated: 2012-11-30

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-10-31

Brief Summary

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Duchenne muscular dystrophy (DMD), an X-linked recessive genetic disease always progressed slowly，tends to leading proximal skeletal muscle atrophy and weakness of limbs, as well as impaired respiratory muscle and cardiac muscle. To a large extent, patients always lose motor function gradually and die for heart failure or severe infection at the end stage of DMD. At present, the treatment strategy relies on heteropathy accompanied with rehabilitation training. However, the therapeutic effect remains extremely limited.

Human umbilical cord mesenchymal stem cells (hUC-MSCs) have been evidenced to improve motor function, increase muscle strength and reduce abnormal levels of related enzymes, such as creatine kinase (CK), lactate dehydrogenase (LDH), alanine aminotransferase (ALT) and aspartate aminotransferase (AST). This study is aimed to explore the safety and efficacy of hUC-MSCs transplantation for DMD.

Detailed Description

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This study is designed to investigate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients with progressive muscular dystrophy.

Conditions

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Duchenne Muscular Dystrophy

Keywords

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Duchenne muscular dystrophy Human Umbilical Cord Mesenchymal Stem Cells

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Group

Participants will be given rehabilitation therapy plus human umbilical cord mesenchymal stem cells transplantation with one year follow-up

Group Type EXPERIMENTAL

human umbilical cord mesenchymal stem cells

Intervention Type BIOLOGICAL

rehabilitation therapy plus human umbilical cord mesenchymal stem cells

Interventions

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human umbilical cord mesenchymal stem cells

rehabilitation therapy plus human umbilical cord mesenchymal stem cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Aged 5-12 years
* Clinical manifestation, enzymology, electromyogram, gene type confirmed the diagnose of Duchenne muscular dystrophy
* Sign the consent form and follow the clinic trail procedure

Exclusion Criteria

* Not Duchenne muscular dystrophy
* Any history of hypersensitivity to serum products,or other know drug and food allergy
* Combined Pneumonia or other Severe systemic bacteria infection
* HIV+, TPPA +， patients diagnosed as HBV or HCV
* Tumor Markers +
* Severe psychotic patients, cognitive dysfunction
* Coagulation disorders
* Uncontrolled hypertension after treatment，blood pressure≥180mmHg/110 mmHg
* Other severe systemic or organic disease
* Enrollment in other trials in the last 3 months
* Received any stem cell therapy in past 6 months
* Other criteria that investigator consider improper for inclusion
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role collaborator

Shenzhen Beike Bio-Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Liqing Yao

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Kunming Medical University

Locations

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The Second Affiliated Hospital of Kunming Medical College

Kunming, Yunnan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liqing Yao

Role: CONTACT

Email: [email protected]

Facility Contacts

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Liqing Yao

Role: primary

Other Identifiers

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BKCR-DMD-1(Ⅰ)

Identifier Type: -

Identifier Source: org_study_id