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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01610440 |
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Date of registration:
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21/05/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Duchenne Muscular Dystrophy
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Scientific title:
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Phase I/II Study of Stem Cell Therapy in Patients With Duchenne Muscular Dystrophy |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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15 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01610440 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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China
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Contacts
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Name:
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Liqing Yao |
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Address:
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Telephone:
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Email:
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yaoliqing98731@yahoo.com.cn |
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Affiliation:
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Name:
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Liqing Yao |
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Address:
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Telephone:
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Email:
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yaoliqing98731@yahoo.com.cn |
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Affiliation:
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Name:
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Liqing Yao |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Second Affiliated Hospital of Kunming Medical University |
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Key inclusion & exclusion 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
Age minimum:
5 Years
Age maximum:
12 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Duchenne Muscular Dystrophy
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Intervention(s)
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Biological: human umbilical cord mesenchymal stem cells
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Primary Outcome(s)
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Activities of Daily Living(ADL)scale
[Time Frame: 1 year after treatment]
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Secondary Outcome(s)
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Change from baseline in LDH
[Time Frame: 1 year after treatment]
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Change from baseline in CK
[Time Frame: 1 year after treatment]
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Change from baseline in ALT
[Time Frame: 1 year after treatment]
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Change from baseline to manual muscle test(MMT)
[Time Frame: 1 year after treatment]
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Change from baseline in electromyography(EMG)
[Time Frame: 1 year after treatment]
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Incidences of Adverse Event and Serious Adverse Event
[Time Frame: 1 year after treatment]
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Change from baseline in AST
[Time Frame: 1 year after treatment]
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Secondary ID(s)
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BKCR-DMD-1(?)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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