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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250310065011N1

Enrollment

Registered

2025-04-17

Start date

2025-05-22

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimers disease. Alzheimers disease

Interventions

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 th

Eligibility

Sex/Gender

All

Age

50 Years to 85 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: (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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Yousef Karimi

Artesh University of Medical Sciences

ymkarimi@yahoo.com+98 21 7798 2349

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026