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IRCT20150206020981N3 IRCT 2022-06-07 Research Deputy of Islamic Azad University, Tehran Medical Branch Efficacy of autologous adipose tissue-derived mesenchymal stem cell therapy in Duchenne muscular dystrophic patients Evaluation of safety and efficacy of autologous adipose-derived mesenchymal cells therapy in Duchenne muscular dystrophy patients 2022-05-31 anticipated 10 Complete https://irct.ir/trial/63760 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Duchenne muscular dystrophy. Intervention group: 100 to 150 cc of SVF product containing 20% mesenchymal cells, 60% progenitor cells and 20% other autologous cells in albumin medium will be injected intravenously through peripheral vein once in 10 to 30 minutes.. Yes - There is a plan to make this available What will be shared: The only some part of data will be shared. When: 5 months after publish To whom: Only academic researcher Conditions: By official permission Where to obtain: By the corresponding author How to obtain: By the official request to the corresponding author, if she/he agrees to it. Comments:
public Khadijeh Hajinaghi Tehrani
Damavand St. Imam Hosein Sq.
Tehran Iran (Islamic Republic of) 17117 +98 21 3334 8035 Khtehrani@iautmu.ac.ir Bu-ali Hospital scientific Khadijeh Hajinaghi Tehrani
Damavaand St. Imam Hosein Sq.
Tehran Iran (Islamic Republic of) 17117 +98 21 3334 8035 Khtehrani@iautmu.ac.ir Bu-ali Hospital Iran (Islamic Republic of) 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 7 years 30 years Male 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 Having blood and internal diseases that increase the risk of liposuction and anesthesia required 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. Insufficient volume of subcutaneous fat or the presence of concomitant injuries in the abdomen in the initial examination that make it difficult to obtain adipose tissue to prepare SVF. G71.01 Muscular dystrophy Treatment - Other Intervention group: 100 to 150 cc of SVF product containing 20% mesenchymal cells, 60% progenitor cells and 20% other autologous cells in albumin medium will be injected intravenously through peripheral vein once in 10 to 30 minutes. 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. Muscular Enzymes. Timepoint: 1, 3, 6, 9 and 12 month after injection. Method of measurement: Lab Data. Research Deputy of Islamic Azad University, Tehran Medical Branch Approved 2022-04-26 Ethics Committee on Research Islamic Azad University, Tehran Medical Branch Attari Moghadam Ave, Khaghani Ave, Shariati Ave, Islamic Azad University, Tehran Medical Branch Tehran Tehran Iran (Islamic Republic of)