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Safety evaluation ofstem cells in multiple sclerosis patients

Safety evaluation of umbilical cord derived mesenchymal stem cells in multiple sclerosis patients

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230806059052N1
Enrollment
5
Registered
2023-09-18
Start date
2023-08-23
Completion date
Unknown
Last updated
2023-10-16

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: The tests before the injection are performed on an outpatient basis and the patient is admitted to the hospital on the day of the injection, and the patient will be hospitalized fo

Sponsors

Bagheiat-allah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: MS diagnosed based on McDonalds criteria Secondary progressive patients who are treated with monoclonal antibodies EDSS score between 2 and 7 after at least 3 months have passed since the last attack

Exclusion criteria

Exclusion criteria: Active proliferative retinopathy Poor diabetes control (HbA1c greater than 8.5) Renal failure (creatinine more than 2.5) Infection (WBC more than 15000 and/or body temperature more than 38 degrees Celsius) Organ transplant history Active malignancy or its history in the past Cardiovascular disease pregnant women Having a positive PCR test for Covid-19 Mental disorders

Design outcomes

Primary

MeasureTime frame
The danger and side effects of mesenchymal stem cell transplantation in terms of causing pain. Timepoint: injection day and 1, 3, 6 and 12 months after stem cell injection. Method of measurement: Patient self-report.;Degree of disability. Timepoint: before injection and 1, 3 and 12 months after stem cell injection. Method of measurement: with EDSS index.;Safety and side effects of mesenchymal stem cell transplantation in terms of hypersensitivity. Timepoint: injection day and 1, 3, 6 and 12 months after stem cell injection. Method of measurement: Clinical observation.;The safety of stem cell injection in terms of causing infection and inflammation. Timepoint: injection day and 1, 3, 6 and 12 months after stem cell injection. Method of measurement: CBC ESR CRP.;The safety of stem cell injection in terms of damage to the liver. Timepoint: injection day and 1, 3, 6 and 12 months after stem cell injection. Method of measurement: AST ALT.;The safety of stem cell injection in terms of kidney dysfunction. Timepoint: injection day and 1, 3, 6 and 12 months after stem cell injection. Method of measurement: BUN Creatinine U/A.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyyed Javad Hosseini Nejad Anbaran

Bagheiat-allah University of Medical Sciences

Javadhoseini1360@gmail.com+98 21 8126 3832

Outcome results

None listed

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