Evaluation of safety and efficacy of focal intramuscular injection of wharton’s gelly-derived mesenchymal stem cell in Duchenne muscular dystrophy pediatrics between 4 to 20 years old
Phase 1
- Conditions
- Duchenne muscular dystrophy.Muscular dystrophyG71.0
- Registration Number
- IRCT20150206020981N5
- Lead Sponsor
- Sinacell Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 16
Inclusion Criteria
Age between 4 to 20
Genetic evidence of Duchenne disease as a cause of myopathy
The patient's muscle strength is decreasing
Willingness and satisfaction to participate in the study by the patient's legal guardian in decision making and willingness to participate regularly in follow-up courses
Weight between 14 to 75
Exclusion Criteria
A history of known malignancy
History of associated genetic and non-genetic degenerative diseases
A history of any other acute or chronic illness that, at the discretion of the clinician responsible for implementing the plan, prevents the patient from entering the study.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Respiratory Function. Timepoint: 1, 3, 6, and 9 months after injection. Method of measurement: Spirometery.;Muscular Force. Timepoint: First every 14 days to 1 month, then Every 1 month to 9 months. Method of measurement: Physical Exam and dynamometer.;Cardiac Function. Timepoint: 1, 3, 6, and 9 months after injection. Method of measurement: Echocardiography.
- Secondary Outcome Measures
Name Time Method Muscular Enzymes. Timepoint: 1, 3, 6, and 9 months after injection. Method of measurement: Lab Data.