Evaluation of the complications of injecting a combination of two types of muscle-derived and adipose-derived stem cells in patients with fascioscapulohumeral dystrophy
Phase 1
- Conditions
- Facioscapulohumeral dystrophy.Scapulohumeral muscular dystrophyG71.02
- Registration Number
- IRCT20080728001031N25
- Lead Sponsor
- Royan Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Facial muscles weakness including Frontalis, Orbicularis oculi, Orbicularis Oris
Having the FSHD phenotype including involvement of the biceps and triceps muscles
Confirmation of FSHD by genetic testing
Age: 15-50 years old
Exclusion Criteria
Comorbidities such as heart and respiratory disease and diabetes
Having a connective tissue or rheumatologic disease or a history of malignancy
Inability to sign consent
Advanced disease
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of people with side effects including hematoma, myalgia and mass at the injection site, decreased level of consciousness, nausea and vomiting, headache, diplopia, urinary and fecal impairments, shortness of breath, increase or decrease in blood pressure. Timepoint: 24 hours after injection - 1 month after injection - 2 months after injection - 4 months after injection - 6 months after injection - 12 months after injection. Method of measurement: Clinical examination and the side-effects questionnaire.
- Secondary Outcome Measures
Name Time Method Disease progression by measuring CPK. Timepoint: 24 hours after injection 1 month after injection 2 months after injection_ 4 months after injection_ 6 months after injection_ 12 months after injection. Method of measurement: Blood test.;Disease progression by measuring LDH. Timepoint: 24 hours after injection 1 month after injection 2 months after injection_ 4 months after injection_ 6 months after injection_ 12 months after injection. Method of measurement: Blood test.