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IRCT20110628006907N18 IRCT 2023-03-11 ROYAN stem cell technology Co Effects of umbilical cord derived mesenchymal stem cells injection in the treatment of children with cerebral palsy MSCCP A Triple blinded, Parallel Randomized clinical trial Phase II&III of 3 Times Intrathecal Injections of an Umbilical Cord-Derived Mesenchymal Stromal Cell Product “WhartoCell” in Children with Cerebral Palsy 2023-05-05 anticipated 150 Complete https://irct.ir/trial/68950 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Designing of 3 injection of stem cells with defined interval in intervention group - including of hemiparetic CP in the study, Randomization description: The patients are randomly allocated into two groups of intervention and control using a balanced block randomization technique. To do that, they were divided into blocks of 6 and 9. All subjects randomly allocated with online randomization software to generate random-number sequences. {Sealed Envelope Ltd. 2015. Create a blocked randomization list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 15 Dec 2015]}. Coordinator and Physician responsible for assessing inclusion / exclusion criteria and registering individuals are blind, Blinding description: As this study designed as triple blind, In the control group after insertion of the needle into the skin with an appearance of simulating of lumbar puncture no injection were done without the awareness of the patients or their parents and clinical evaluators . At the end of the study if safety and effectiveness of cell therapy will be proved , for ethical consideration cell therapy will be performed for control group. 2-3 Spastic Cerebral Palsy. Intervention 1: Intervention group: CP patients receiving ،three intrathecal injection of 20 millions allogenic mesenchymal stem cells derived from umbilical cord (whartocell) , prepared by Cell Thec Pharmed Company. Interval of injections is every 2 weeks . Intrathecal injection will be done under anesthesia via lumbar puncture . After taking 3-5 milliliter of cerebrospinal fluid , 2 milliliter prepared stem cells will be injected with a syringe . The patient will be admitted for one day for monitoring of probable adverse reactions . One year follow up and evaluation with regular similar rehabilitative therapy will be done . Intervention 2: Control group: : CP patients without injection, that after insertion of needle into the skin without entering into the cerebrospinal fluid space, needle will be withdrawn without any injection and only with an appearance of simulation of lumbar puncture without the awareness of the patient or their parents. The patient will be admitted one day for monitoring of probable adverse reaction . One year follow up and evaluation with regular similar rehabilitative therapy will be done. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD can be shared6 months after publication When: 6 months after publication To whom: People working in academic institutions and people working in businesses Conditions: Planning of similar studies in other academic centers Where to obtain: Email address How to obtain: After request during the 1-2 months Comments:
public Anahita Majmaa
Children's Medical Center Hospital, No 62, Gharib Street, End of Keshavarz Blvd, Tehran
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6612 9252 majmaaa911@yahoo.com Tehran University of Medical Sciences scientific Mahmoud Reza Ashrafi
Children's Medical Center Hospital, No 62, Gharib Street, End of Keshavarz Blvd, Tehran
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6612 9252 ashrafim@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Spastic cerebral palsy (Dip, Quadri, Hemiparetic ) Ages between 2 - 14 years Gross motor function classification (GMFC) 2 -4 No seizure disorder or with controlled seizure Acquired brain MRI finding compatible with CP Informed consent of parents 2 years 14 years Both Normal brain MRI Progressive neurological diseases Congenital brain cortical malformations TORCH infections( Toxoplasmosis, Others, Rubella Cytomegalovirus Hepatitis C ) Other types of cerebral palsy (athetoid , atonic , ataxic , mixed ) Acute infections (Human Immunodeficiency Virus , Hepatitis C Virus ) Hemorrhagic diathesis Severe anemia ( Hemoglobin less than 8 ) Ventilator dependent pulmonary diseases Severe renal dysfunction Severe liver dysfunction G80.0 Spastic quadriplegic cerebral palsy Treatment - Other Treatment - Other Intervention group: CP patients receiving ،three intrathecal injection of 20 millions allogenic mesenchymal stem cells derived from umbilical cord (whartocell) , prepared by Cell Thec Pharmed Company. Interval of injections is every 2 weeks . Intrathecal injection will be done under anesthesia via lumbar puncture . After taking 3-5 milliliter of cerebrospinal fluid , 2 milliliter prepared stem cells will be injected with a syringe . The patient will be admitted for one day for monitoring of probable adverse reactions . One year follow up and evaluation with regular similar rehabilitative therapy will be done . Control group: : CP patients without injection, that after insertion of needle into the skin without entering into the cerebrospinal fluid space, needle will be withdrawn without any injection and only with an appearance of simulation of lumbar puncture without the awareness of the patient or their parents. The patient will be admitted one day for monitoring of probable adverse reaction . One year follow up and evaluation with regular similar rehabilitative therapy will be done Motor development alteration with GMFM 66 score. Timepoint: Before intervention , 3 months after first intervention ,6 months after first intervention , 12 months after first intervention. Method of measurement: GMFM 66 score Questionnaire. Change of motor function with GMFCS score. Timepoint: Before intervention, 3 months after first intervention, 6 months after first intervention, 12 months after first intervention. Method of measurement: GMFCS Questionnaire. Change of motor function according to PEDI score. Timepoint: Before intervention, 3 months after first intervention, 6 months after first intervention, 12 months after first intervention. Method of measurement: PEDI Questionnaire. Change of motor function according to MACS score. Timepoint: Before intervention, 3 months after first intervention, 6 months after first intervention, 12 months after first intervention. Method of measurement: MACS Questionnaire. Spasticity change of patients according to Ashworth scale. Timepoint: Before intervention, 3 months after first intervention, 6 months after first intervention, 12 months after first intervention. Method of measurement: Ashworth Questionnaire. Change of quality of life. Timepoint: Before intervention, 6 months after first intervention, 12 months after first intervention. Method of measurement: CPQOL Questionnaire. Probable Change of brain lesions. Timepoint: Before intervention, 1 year after first intervention. Method of measurement: Brain Magnetic Resonance Imaging (MRI), Brain Magnetic Resonance Spectroscopy (MRS), Brain Deep Tensor Imaging (DTI). Number of participants experiencing adverse effects and serious adverse effects. Timepoint: First 24 hours after injection and then any time if occurred. Method of measurement: Questionnaire, parents report and periodic planned clinical evaluations. Celltechphamed Co. ROYAN stem cell technology Co Celltechphamed Co. Approved 2023-01-09 Research Ethics Committee of Research Institute for Oncology Hematology and Cell therapy- Tehran Un North Kargar, Jalale aleahmad Cross Dr Shariati Hospital Tehran Tehran Iran (Islamic Republic of)