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IRCT201706176907N13 IRCT 2017-07-12 Tehran University of Medical Sciences Effects of umbilical cord derived stem cells injection in the treatment of children with cerebral palsy Evaluation of the efficacy of allogeneic umbilical cord derived hematopoietic and mesenchymal stem cells on developmental functions of spastic cerebral palsy patients between 4-14 years old in comparison with control group , A Clinical trial phase II 2017-11-22 anticipated 108 Complete https://irct.ir/trial/7342 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: For the first time in our country , intrathecal injection of mesenchymal stem cells derived from umbilical cord for the treatment of CP applied , Randomization description: The patients are randomly allocated into three 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. Due to necessity of HLA matching of hematopoietic stem cells derived from allogenic umbilical cord (MNC) group we selected 150 cases of referred patients with our inclusion criteria and HLA analysis were done for these patients and then 36 cases of class 6 matched patients enrolled to the MNC group and 72 cases among the remaining patients randomly divided to Mesenchymal stem cells derived from allogenic umbilical cord (MSC) and control group . Therefore 108 cases enrolled in 3 divided group of 36 patients , Blinding description: As this study designed as double blind , In the control group after insertion of the needle into the skin with an appearance of simulation 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 Spastic Cerebral Palsy. Intervention 1: Intervention group 1 one intrathecal injection of hematopoietic stem cell derived from umbilical cord ( 5 millions per Kg ) prepared by Royan stem cell Technology Company . Intrathecal injection will be done under anesthesia via lumbar puncture . After taking 5 milliliter of cerebrospinal fluid prepared stem cells will be injected with a syringe . The patient will be admitted for one day of probable adverse reaction observation . One year followup and evaluation with regular similar rehabilitative therapy will be done . Intervention 2: Intervention group 2 one intrathecal injection of mesenchymal stem cellls derived from umbilical cord ( 1 million per kg) prepared by Cell Thec Pharmed Company. Intrathecal injection will be done under anesthesia via lumbar puncture . After taking 5 milliliter of cerebrospinal fluid prepared stem cells will be injected with a syringe . The patient will be admitted for one day of probable adverse reaction observation . One year followup and evaluation with regular similar rehabilitative therapy will be done . Intervention 3: Control group 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 for one day of probable adverse reaction observation . One year followup and evaluation with regular similar rehabilitative therapy will be done . Yes - There is a plan to make this available What will be shared: IPD collected for the primary outcomes and secondary outcome measures When: Dec 2019 To whom: people working in academic institutions , people working in businesses and patients Conditions: Publications of study Where to obtain: Contact persons How to obtain: Telephone or email Comments:
public Anahita Majmaa
Children's Medical Center Hospital , No 62 , Gharib Street , End of Keshavarze 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 , 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 (Diparetic , Quadriparetic) Ages between 4 - 14 years Gross motor function classification (GMFC) between 2 -5 No seizure disorder or with controlled seizure Evidence of definite acquired abnormal imaging findings compatible with Cerebral Palsy Informed consent taken from their parents 4 years 14 years Both Normal brain MRI Progressive neurological diseases ( for example leukodystrophy or neurometabolic disorders) Congenital Cortical malformations Toxoplasmosis Others Rubella Cytomegalovirus Hepatitis (TORCH) infections Other types of cerebral palsy including athetoid , atonic , ataxic , and mixed type Acute intercurrent infections such as Hepatitis C Virus ( HCV), Hepatitis B Virus (HBV) ,Human Immunodeficiency Virus (HIV) Hemorrhagic diathesis Severe anemia ( Hemoglobin less than 8 ) Ventilator dependent pulmonary diseases Renal insufficiency Severe liver dysfunction G80.9 Cerebral Palsy , Unspecified Treatment - Drugs Treatment - Drugs Treatment - Other Intervention group 1 one intrathecal injection of hematopoietic stem cell derived from umbilical cord ( 5 millions per Kg ) prepared by Royan stem cell Technology Company . Intrathecal injection will be done under anesthesia via lumbar puncture . After taking 5 milliliter of cerebrospinal fluid prepared stem cells will be injected with a syringe . The patient will be admitted for one day of probable adverse reaction observation . One year followup and evaluation with regular similar rehabilitative therapy will be done . Intervention group 2 one intrathecal injection of mesenchymal stem cellls derived from umbilical cord ( 1 million per kg) prepared by Cell Thec Pharmed Company. Intrathecal injection will be done under anesthesia via lumbar puncture . After taking 5 milliliter of cerebrospinal fluid prepared stem cells will be injected with a syringe . The patient will be admitted for one day of probable adverse reaction observation . One year followup and evaluation with regular similar rehabilitative therapy will be done . Control group 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 for one day of probable adverse reaction observation . One year followup and evaluation with regular similar rehabilitative therapy will be done . Motor development alteration with GMFM 66 score. Timepoint: Before intervention , 1 month after intervention , 3 months after intervention ,6 months after intervention , 12 months after intervention. Method of measurement: questionairre. Change of motor function with GMFCS score. Timepoint: Before intervention , 1 month after intervention , 3 months after intervention ,6 months after intervention , 12 months after intervention. Method of measurement: questionairre. Spasticity change of patients according to Ashworth scale. Timepoint: Before intervention , 1 month after intervention , 3 months after intervention ,6 months after intervention , 12 months after intervention. Method of measurement: questionairre. Developmental status according to Stanford Binet test. Timepoint: Before intervention , 1 month after intervention , 3 months after intervention ,6 months after intervention , 12 months after intervention. Method of measurement: questionairre. Probable Change of brain lesions. Timepoint: Before intervention , 1 year after intervention. Method of measurement: Brain Magnetic Resonance Imaging (MRI) , Brain Magnetic Resonance Spectroscopy (MRS) , Brain Deep Tensor Imaging (DTI). Fever. Timepoint: 24 hours after intervention , 48 hours after intervention , 72 hours after intervention. Method of measurement: Axillary thermometer. Meningitis. Timepoint: First 3 days after intervention or any time after intervention. Method of measurement: Lumbar Puncture. Hyper sensitivity reactions. Timepoint: First week after intervention. Method of measurement: Physical exam. ROYAN stem cell technology Co Welfare Organization of Iran Hormozgan University of Medical Sciences NCT03795974 Clinical trials.gov Tehran University of Medical Sciences ROYAN stem cell technology Co Welfare Organization of Iran Hormozgan University of Medical Sciences Approved 2017-06-06 Ethic committee of Tehran university of Medical Sciences Tehran University of Medical Sciences ,Ghods street , Keshavarz Blvd ,Tehran Tehran Tehran Iran (Islamic Republic of)