Status:
COMPLETED
Effects of Repeated Mesenchymal Stem Cells (MSC) in Patients With Progressive Multiple Sclerosis
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
An open prospective study with multiple (every 6-12 months) intrathecal or intravenous injections of autologous MSC in patients with progressive forms of MS (secondary progressive, primary progressive...
Detailed Description
An open prospective study with multiple intrathecal or intravenous injections of autologous MSC in 24 patients with progressive forms of MS (secondary progressive, primary progressive or relapsing-pro...
Eligibility Criteria
Inclusion
- Consenting patients fulfilling the Poser's criteria for definite MS
- Age 18-70
- Male and female
- EDSS rate 5.5-7.5 (moderate to high disability)
- Failure to two lines of the currently available registered immunomodulatory treatments for MS. The lack of response to these treatments was determined by either an increase in EDSS or the appearance of at least two relapses of MS during the year prior to inclusion.
Exclusion
- Patients who were treated with cytotoxic medications during the last three months prior to the infusion.
- Patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results.
- Patients with active infections.
- Patients with cognitive decline or inability to understand and sign the informed consent.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04823000
Start Date
January 1 2013
End Date
April 1 2020
Last Update
March 30 2021
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