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IRCT20200904048610N1 IRCT 2023-05-09 Mashhad University of Medical Sciences Effects of cell therapy and exosome in the treatment of amyotrophic lateral sclerosis Safety and Efficacy of Bone marrow derived-mesenchymal stem cells in comparison with their exosomes in Amyotrophic Lateral Sclerosis: A randomized controlled phase 1 study 2023-06-22 anticipated 5 Complete https://irct.ir/trial/69894 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who meet the inclusion criteria are randomly assigned to treatment and control groups after signing the informed consent form. Random allocation will be done by a person outside the study using a computerized randomization program and random blocks of four people, Blinding description: Random allocation will be done by an individual outside the study. This randomization technique will be used to ensure that principal investigators are blinded to random allocation. According to the study design, the researcher who implements the cell or exosome injection intervention will be aware of the groups. However, unblinded clinical teams administering the cells or exosome (anaesthesiologist or other teams) will not have contact with participants before or after administration. Also, the data collection and analysis of the study will be done by a research assistant who is blinded to the allocation and intervention. 1 Amyotrophic Lateral Sclerosis. Intervention 1: Intervention group: They receive MSCs derived from bone marrow. Intervention 2: Intervention group: They receive exosomes. Intervention 3: Intervention group: They receive bone marrow-derived mesenchymal stem cells along with exosomes. Intervention 4: Control group: Receives routine drug therapy. Yes - There is a plan to make this available What will be shared: Not applicable When: Not applicable To whom: Not applicable Conditions: Not applicable Where to obtain: Not applicable How to obtain: Not applicable Comments:
public Sajad Sahab Negah
Fcaulty of Medicine, Azadi Sq
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2473 Sahabnegahs@mums.ac.ir Mashhad University of Medical Sciences scientific Sajad Sahab Negah
Fcaulty of Medicine, Azadi Sq
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3800 2473 sahabnegahs@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of ALS (according to laboratory findings or El Escorial criteria) Duration of symptoms less than 36 months Progressive muscle weakness in the lower limb, based on EMG in the lower limb bilaterally Mandatory vital capacity more than 60% of the predicted normal in lying on the back Age 18 and above Ability to provide informed consent The person can be geographically available and refer for the required visits. Being accompanied by a caregiver and performing the care needed by him during the study Failure to use riluzole or a fixed dose in the previous 30 days or more In women of reproductive age, having a negative pregnancy test before stem cell injection Medically able to perform thoracolumbar laminectomy or laminoplasty as determined by the surgeon. Medically able to tolerate an immunosuppressive regimen. 18 years no limit Both Use of aggressive breathing equipment Diagnosis of other significant or unstable medical and clinical conditions that can interfere with the study. The occurrence of any of the following situations: Alcohol consumption with illegal and non-prescription drugs, Appearance of known immunodeficiency syndrome, Unstable medical conditions, Occurrence of unstable psychiatric diseases including psychosis, or major depression People of reproductive age who are not interested in birth control. Receiving any other investigational device or drug Any condition in the lower limb that prevents the testing of muscle strength Any condition that the specialist feels can cause difficulty in performing injections and follow-ups Any condition or subset of ALS that the researcher feels could interfere with the study or final interpretation. G12.21 Amyotrophic lateral sclerosis Treatment - Other Treatment - Other Treatment - Other N/A Intervention group: They receive MSCs derived from bone marrow. Intervention group: They receive exosomes. Intervention group: They receive bone marrow-derived mesenchymal stem cells along with exosomes. Control group: Receives routine drug therapy. Score in revised ALS functional rating scale (ALSFRS-R). Timepoint: 1, 3 and 6 months and 1 year. Method of measurement: revised ALS functional rating scale (ALSFRS-R). The patient's score is Forced Vital Capacity (FVC). Timepoint: 1, 3 and 6 months and 1 year. Method of measurement: Spirometry. Patient-centered Approved 2023-03-11 Research Ethics Committees of Mashhad University of Medical Sciences Qurshi Building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)