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IRCT20161212031362N3 IRCT 2023-01-18 Tehran University of Medical Sciences Investigation of safety and efficacy of intrathecal and intravenous injection of umbilical cord-derived mesenchymal stem cells Investigation of safety and efficacy of intrathecal and intravenous injection of umbilical cord-derived mesenchymal stem cells (UC-MSC) in patients with multiple sclerosis 2023-01-20 anticipated 5 Complete https://irct.ir/trial/67054 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Multiple Sclerosis. Intervention group: Patient with multiple sclerosis; A) Intrathecal injection of mesenchymal stem cells: 1. Patient admission to the hospital. It is better to hospitalize the patients 24 to 48 hours after the injection of mesenchymal stem cells. 2. Mesenchymal stem cells are delivered in 3 to 4 cc of normal saline solution, and the injection should be performed within 6 hours. 3. Before injection, place the solution containing the cells in the room for 20 minutes to reach room temperature. 4. Do not use alcohol or betadine to sterilize the injection area because it damages the cells hit. 5. Shake the solution gently to homogenize the cells. 6. The 24 g spinal needle is placed in the standard position between the 2nd and 5th lumbar vertebra. 7. After collecting 3-5 ccs of CSF sample for baseline analysis, the solution containing mesenchymal stem cells is injected into the CSF with gentle hand pressure within 1 to 2 minutes, and then 1CC Ringer lactate or normal saline is injected. 8. After the cell injection, the patient is placed in Trendelenberg position 10 degrees and every 15 minutes is rotated on its sides for 2 hours to maximize even distribution of cells in the CSF. 9. Antibiotics can be prescribed to prevent meningitis. B) Intravenous injection of mesenchymal stem cells: 1. Patient admission to the hospital. It is better to hospitalize the patients 24 to 48 hours after the injection of mesenchymal stem cells. 2. Mesenchymal stem cells are delivered in 10 ccs of normal saline and 5% albumin solution and must be injected within 6 hours after delivery. 3. Before injection, place the solution containing the cells in the room for 20 minutes to reach room temperature. 4. Gently shake the solution to homogenize the cells. 5. Remove the cells with a 10 cc syringe and inject them into 100 to 200 cc of normal saline serum. 6. The serum should be infused into the patient's vein within 20 minutes. 7. It is recommended to prescribe agonists of H1 and H2 receptors to prevent allergic reactions before injection and monitor patients for 2 hours. 8. Before and after cell injection, patients should receive 5000 units of heparin (10000 units in total).. 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 There is no further information
public Mohammad hossein Harirchian
Iranian Center of Neurological Research, Imam Khomeini Hospital, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 4979133141 +98 21 6694 8899 harirchm@tums.ac.ir Tehran University of Medical Sciences scientific Dr Mohammad Hossein Harirchian
Fourth Floor, Iranian Center of Neurological Research Building, Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6694 8899 harirchm@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) McDonald's 2017 diagnostic criteria for multiple sclerosis 18 years 55 years Both Any history of severe disease that interferes with study results, such as cancer, severe kidney disease, liver disease, digestive disease, heart disease, or any uncontrolled disease Cognitive Disorder, Inability in fill out the consent form voluntarily G35 Multiple sclerosis Treatment - Drugs Intervention group: Patient with multiple sclerosis; A) Intrathecal injection of mesenchymal stem cells: 1. Patient admission to the hospital. It is better to hospitalize the patients 24 to 48 hours after the injection of mesenchymal stem cells. 2. Mesenchymal stem cells are delivered in 3 to 4 cc of normal saline solution, and the injection should be performed within 6 hours. 3. Before injection, place the solution containing the cells in the room for 20 minutes to reach room temperature. 4. Do not use alcohol or betadine to sterilize the injection area because it damages the cells hit. 5. Shake the solution gently to homogenize the cells. 6. The 24 g spinal needle is placed in the standard position between the 2nd and 5th lumbar vertebra. 7. After collecting 3-5 ccs of CSF sample for baseline analysis, the solution containing mesenchymal stem cells is injected into the CSF with gentle hand pressure within 1 to 2 minutes, and then 1CC Ringer lactate or normal saline is injected. 8. After the cell injection, the patient is placed in Trendelenberg position 10 degrees and every 15 minutes is rotated on its sides for 2 hours to maximize even distribution of cells in the CSF. 9. Antibiotics can be prescribed to prevent meningitis. B) Intravenous injection of mesenchymal stem cells: 1. Patient admission to the hospital. It is better to hospitalize the patients 24 to 48 hours after the injection of mesenchymal stem cells. 2. Mesenchymal stem cells are delivered in 10 ccs of normal saline and 5% albumin solution and must be injected within 6 hours after delivery. 3. Before injection, place the solution containing the cells in the room for 20 minutes to reach room temperature. 4. Gently shake the solution to homogenize the cells. 5. Remove the cells with a 10 cc syringe and inject them into 100 to 200 cc of normal saline serum. 6. The serum should be infused into the patient's vein within 20 minutes. 7. It is recommended to prescribe agonists of H1 and H2 receptors to prevent allergic reactions before injection and monitor patients for 2 hours. 8. Before and after cell injection, patients should receive 5000 units of heparin (10000 units in total). The disability degree. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: EDSS index, functional examination of body systems in 8 aspects: pyramidal, cerebellar, brainstem, sensory, urinary and digestive, visual, cerebral and other aspects of a person's ability to walk. Walking performance. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Questionnaire - Timed 25-Foot Walk, the time a person can walk 25 feet, a maximum time of 3 minutes. Upper extremity motor skill performance. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Questionnaire 9 hole peg test, the time that a person can put the pegs in the hole and then take them out of the hole. Maximum time is 5 minutes. Cognitive function. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Paced Auditory Serial Addition Test (PASAT) questionnaire, a number is said every 3 seconds and the person must add two consecutive numbers together. The number of correct answers is between 0-60. Tehran University of Medical Sciences Approved 2022-11-11 Ethic Committee of Neuroscience Institute , Tehran University of Medical Sciences Neuroscience Institute, Imam Khomeini Hospital complex; Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)