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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20161212031362N3

Enrollment

Registered

2023-01-18

Start date

2023-01-20

Completion date

Unknown

Last updated

2023-02-07

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

Conditions

Multiple Sclerosis. Multiple sclerosis

Interventions

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. Mese

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: McDonald's 2017 diagnostic criteria for multiple sclerosis

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad hossein Harirchian

Tehran University of Medical Sciences

harirchm@tums.ac.ir+98 21 6694 8899

Outcome results

None listed

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