Duchenne muscular dystrophy. Muscular dystrophy
Conditions
Interventions
Intervention group: Intervention group: In each injection, 1million mesenchymal cell derived from Wharton's gelly is injected per kilogram of body weight. The injection volume of 25 cc includes a susp
Sponsors
Sinacell Company
Eligibility
Sex/Gender
Male
Age
4 Years to 20 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Muscular Enzymes. Timepoint: 1, 3, 6, and 9 months after injection. Method of measurement: Lab Data. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactKhadijeh Hajinaghi Tehrani
Islamic Azad University
Outcome results
None listed