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IRCT20200502047277N5 IRCT 2021-01-15 Shahid Beheshti University of Medical Sciences Investigation of the Effect of Stem Cells Injection in Children with Cerebral Palsy Safety and Therapeutic Effect of Autologous Bone Marrow Mesenchymal Stem Cell Transplantation in Children with Cerebral Palsy: Clinical Trial Phase I-II 2018-10-22 anticipated 46 Complete https://irct.ir/trial/48809 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 1-2 Cerebral palsy. Intervention 1: Intervention group: At first, the patient's personal and demographic information will be recorded completely. The necessary questionnaires and physical examinations will be performed and the results will be recorded. In this group, patients' stem cells will be isolated by bone marrow aspiration. After culturing and preparing the cells, MSC cells will be transplanted at a concentration of 1 million cells per ml prepared through a puncture lumbar in the L4 / L5 region. Patients will undergo periodic examinations in neurology clinic at regular intervals after transplantation. patients' sensory and motor function, spasticity and balance will be assessed. In addition, patients are examined for complications such as headache, stiff neck, nausea and vomiting, shortness of breath, jaundice and infection,. Intervention 2: Control group: In this group, patients do not receive cell injection and receive supportive therapies. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information
public Saeed Oraee Yazdani
Shohadaye Tajrish Hospital, Tajrish Ave.
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 Saeed_o_yazdani@yahoo.com Shahid Beheshti University of Medical Sciences scientific Saeed Oraee Yazdani
Shohadaye Tajrish Hospital, Tajrish Ave.
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 Saeed_o_yazdani@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of cerebral palsy No seizures or with controlled seizures Parental consent 1 year 18 years Both Severe cognitive disease Hydrocephalus Coagulation diseases Have diseases such as cancer, active infections and heart, kidney and liver diseases Evidence of a progressive neurological disease Evidence of a genetic disease G80 Cerebral palsy Treatment - Other Other Intervention group: At first, the patient's personal and demographic information will be recorded completely. The necessary questionnaires and physical examinations will be performed and the results will be recorded. In this group, patients' stem cells will be isolated by bone marrow aspiration. After culturing and preparing the cells, MSC cells will be transplanted at a concentration of 1 million cells per ml prepared through a puncture lumbar in the L4 / L5 region. Patients will undergo periodic examinations in neurology clinic at regular intervals after transplantation. patients' sensory and motor function, spasticity and balance will be assessed. In addition, patients are examined for complications such as headache, stiff neck, nausea and vomiting, shortness of breath, jaundice and infection,.... Control group: In this group, patients do not receive cell injection and receive supportive therapies. Motor System Functioning. Timepoint: Before injection, 3, 6 and 12 months after the intervention. Method of measurement: Physical examination and motor function will be evaluated by the Gross Motor Function Measure (GMFM-66) and Gross Motor Function Classification System (GMFCS). Balance Assessment. Timepoint: Before injection, 3, 6 and 12 months after the intervention. Method of measurement: Physical examination and Berg Balance Scale will be used to evaluate the balance. Spasticity Assessment. Timepoint: Before injection, 3, 6 and 12 months after the intervention. Method of measurement: Physical examination and Grading of spasticity will be classified by the Modified Ashworth Scale which consist of 5 grades where 0 represents no increase in muscle tone and 5 is rigidity in flexion and extension in the affected part. Motor and Cognitive Disability Assessment. Timepoint: Before injection, 3, 6 and 12 months after the intervention. Method of measurement: Physical examination and Functional Independence Measure (FIM) and Functional Assessment Measure (FAM) will be used to measure patient motor and cognitive disability in a wide range of conditions. Evaluation the side effects of autologous bone marrow derived mesenchymal stem cells transplantation in cerebral palsy patients. Timepoint: 1, 3, 6 and 12 months after injection. Method of measurement: Adverse effects will be assessed based on common terminology criteria for adverse events (CTCAE, version 4.3). Shahid Beheshti University of Medical Sciences Approved 2020-12-28 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Shahid Arabi St., Yemen St., Shahid Chamran Highway, Tehran Tehran Tehran Iran (Islamic Republic of)