Duchenne muscular dystrophy. Muscular dystrophy
Conditions
Interventions
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 suspension containing on
Sponsors
Sinacell Company
Eligibility
Sex/Gender
Male
Age
5 Years to 12 Years
Inclusion criteria
Inclusion criteria: Age between 5 to 12 Genetic evidence of Duchenne disease as a cause of myopathy The patient's ability to walk is not completely lost and the use of assistive devices such as canes and walkers is not permanent. 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 15 to 35
Exclusion criteria
Exclusion criteria: Advanced motor impairment leading to permanent use of crutches, walkers and wheelchairs 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, 9 and 12 month after injection. Method of measurement: Spirometery.;Muscular Force. Timepoint: First every 14 days to 1 month, then Every 1 month to 1 year. Method of measurement: Physical Exam.;Cardiac Function. Timepoint: 1, 3, 6, 9 and 12 month after injection. Method of measurement: Echocardiography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Muscular Enzymes. Timepoint: 1, 3, 6, 9 and 12 month after injection. Method of measurement: Lab Data. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactKhadijeh Hajinaghi Tehrani
Islamic Azad University
Outcome results
None listed