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IRCT20250310065011N1 IRCT 2025-04-17 Artesh University of Medical Sciences Treatment of Alzheimer's disease with mesenchymal stem cells and repetitive pulsed magnetic stimulation (rTMS) Intrathecal injection of mesenchymal stem cells (MSC) and repetitive pulsed magnetic stimulation (rTMS) in patients with Alzheimer's disease: a phase I clinical trial 2025-05-22 anticipated 15 Complete https://irct.ir/trial/82343 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Alzheimer's disease. Intervention group: Alzheimer's patients will receive intrathecal mesenchymal stem cells injections (1 × 10^6 cells per kilogram) (Prepared in one of the specialized stem cell centers in Iran) and then a series of repetitive pulsed magnetic stimulation (40 sessions, 5 days per week, 20 Hertz , 30 pulses per train) (Using devices available in the Iranian market) targeting specific brain regions associated with cognitive function.. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions as well as people working in the industry can apply to receive data. Conditions: The data can be used for research purposes. Where to obtain: Dr. Reza Eslami should be contacted. Email:rezaeslami7@yahoo.com How to obtain: After contact, information is sent within a few days. Comments:
public Dr. Yousef Karimi
No.288, Piroozi st
Tehran Iran (Islamic Republic of) 1781911115 +98 21 7798 2349 ymkarimi@yahoo.com Artesh University of Medical Sciences scientific Dr. Reza Eslami
‏IRIAF‏ ‏Health‏ ‏Administration‏ ‏Deputy‏ ‏of‏ ‏Research‏ ‏and‏ ‏Education, Be'sat‏ ‏Hospital,‎‏ Basidj‏ ‏Highway
Tehran Iran (Islamic Republic of) 1781911115 +98 21 3995 4119 rezaeslami7@yahoo.com Artesh University of Medical Sciences Iran (Islamic Republic of) Age 50 to 85 years Meets criteria for probable Alzheimer's disease dementia according to the National Institute on Aging-Alzheimer's Association (NIA-AA) Working Group Scored 18-26 on the Mini-Mental State Examination (MMSE) screening Eligible patients will then be screened with MRI imaging and will be enrolled in the study once neurodegeneration due to atrophy is confirmed on structural brain MRI 50 years 85 years Both (1) have neurodegenerative diseases other than Alzheimer's disease have severe FLAIR white matter enhancement on MRI at baseline, defined as a cap or band (periventricular white matter enhancement) ≥ 10 mm and deep white matter lesions ≥ 25 mm (based on the modified Fazekas ischemia criteria); have major psychiatric disorders; History of stroke within 3 months of study entry; Active hepatic, renal, hematological, or pulmonary disorders. Current or prior history of malignancy; Intrathecal injection is difficult or contraindicated for the patient. G30 Alzheimer's disease Behavior Intervention group: Alzheimer's patients will receive intrathecal mesenchymal stem cells injections (1 × 10^6 cells per kilogram) (Prepared in one of the specialized stem cell centers in Iran) and then a series of repetitive pulsed magnetic stimulation (40 sessions, 5 days per week, 20 Hertz , 30 pulses per train) (Using devices available in the Iranian market) targeting specific brain regions associated with cognitive function. Montreal Cognitive Assessment Score. Timepoint: At the beginning of the study (before the intervention) and after the last repetitive pulsed magnetic stimulation session. Method of measurement: The MOCA (Montreal Cognitive Assessment) is a psychological tool designed to assess cognitive functions in adults and consists of 30 questions that take approximately 10 to 15 minutes to complete. The test is divided into several sections: attention and concentration (number repetition and naming), short-term memory (word recall), language (describing objects), visual and spatial abilities (copying geometric shapes), as well as executive function and long-term memory. The total score for the test can range from 0 to 30, with a score above 26 considered normal functioning, 18 to 25 indicating mild cognitive impairment, and below 18 indicating moderate or severe cognitive impairment. Artesh University of Medical Sciences Approved 2025-03-01 Research Ethics Committees of AJA University of Medical Sciences Etemadzadeh st, Fatemi gharbi st, Tehran Tehran Tehran Iran (Islamic Republic of)