]>
IRCT20160809029275N3 IRCT 2022-08-31 Mashhad University of Medical Sciences cerebellar ataxia treatment with mesenchymal stem cells Evaluation of safety and motivation status of patients with cerebellar ataxia after intrathecal treatment with mesenchymal stem cells 2021-07-23 anticipated 20 Complete https://irct.ir/trial/65228 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization method using the random number table method was used to assign patients to groups. In this method, even numbers were placed in the intervention group and odd numbers were randomly placed in the control group. 1 Diagnosis Code G32.81: Cerebellar ataxia. Intervention 1: Intervention group: Patients receiving 50-70 million autologous MSCs derived from bone marrow. Intervention 2: Control group: Control group: patients with cerebellar ataxia who will receive routine treatments including vitamin E, CoQ10, physical therapy and occupational therapy. No - There is not a plan to make this available Justification or reason for not sharing IPD is there is no more information
public Dr. Amir Reza Boroumand
Daneshgah st. Kafaei1 Av. Sadra building
Mashhad Iran (Islamic Republic of) 91942167910 +98 51 3848 2194 boroumandar@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Seyyed Jalil tavakol afshari
Bou Ali SQ, Bou Ali Research center
Mashhad Iran (Islamic Republic of) ٩١٩۶٧٧٣١١٧ +98 51 3711 2471 tavakolaj@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Does not receive stem cells in the last 6 months. signing the written consent form by the participants. The age range of 10-65 years without limitation in sex. Definitive diagnosis of ataxia based on brain and cervical spinal cord MRI. Presence of cerebellar or brainstem atrophy and/or cervical spinal cord. Not having other mental illness such as schizophrenia etc. 10 years 65 years Both Positive pregnancy test. Heart, kidney and liver failure, epilepsy, lung disease, cardiac arrhythmia, diabetes, leukemia and other diseases of the central nervous system such as Parkinson's. If the total level of bilirubin is greater than 1.5 times the upper limit of its normal value. History of chronic or acute alcohol consumption The presence of evidence of seizures in the brain scan Any evidence of infection History of severe drug sensitivity or anaphylaxis to two or more foods or drugs Other organic brain diseases HIV positive and tumor markers positive Patients with severe psychosis, cognitive disorders and inability to understand or sign consent Other organic or systemic diseases Uncontrollable high blood pressure Participation in other clinical trials in the last three months The presence of thyroid disease Presence of evidence of encephalitis Presence of sarcoidosis and Behcet's disease Vitamin E deficiency Wilson's disease Increased blood ammonia Positive anti-GAD and anti-neuronal antibodies Lupus and Wegener's disease Middle ear dysfunction G32.81 Cerebellar ataxia in diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: Patients receiving 50-70 million autologous MSCs derived from bone marrow Control group: Control group: patients with cerebellar ataxia who will receive routine treatments including vitamin E, CoQ10, physical therapy and occupational therapy. Neurologic sign of patients including: Scale for the Assessment and Rating of Ataxia (SARA)-Quality of life-Depression-Beck Scale-Improve in international Co-Operative Ataxia Rating Scale-Balance Test-Tremor Rating Scale. Timepoint: Before the intervention, month 3 and month 6 after the intervention. Method of measurement: Clinical examination and questionnaire. Blood markers including: • T4 and TSH• Alpha-fetoprotein• IgG and IgE• OGTT and FBS• ACE• Vitamin E• Electrophoresis of serum proteins• Chol, TG, LDL and HDL• Ceruloplasmin, Cu and 24-hour urine Cu for patients less than 40 years old• Anti-GAD, Anti-dsDNA, P-ANCA and C-ANCA• Vitamin B12 and folic acid. Timepoint: Before the intervention, month 3 and month 6 after the intervention. Method of measurement: Laboratory methods such as electrophoresis, VIDAS and ELISA. Investigating the safety of stem cell treatment in patients participating in the study. Timepoint: 24-48 hours after receiving injections and the third and sixth months. Method of measurement: Clinical examination of patients to check for fever, headache or any possible allergic reactions. Mashhad University of Medical Sciences Approved 2022-07-02 Ethics committee of Mashhad University of Medical Sciences Mashhad,Daneshgah Street, Qurashi Building, Mashhad University of Medical Sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)