Status:
COMPLETED
Neural Stem Cell Transplantation in Multiple Sclerosis Patients
Lead Sponsor:
IRCCS San Raffaele
Collaborating Sponsors:
Fondazione Italiana Sclerosi Multipla
Conditions:
Progressive Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a phase I study evaluating the feasibility, safety and tolerability of intrathecally administered human Neural Stem Cells (hNSCs), at an escalating dose ranging from 0.7x10\^6±10% cells to 5.7...
Detailed Description
This is a prospective, monocentric, national, therapeutic exploratory, phase I, not randomized, open label, not controlled, single dose escalation clinical trial. Each subject will participate in the...
Eligibility Criteria
Inclusion
- Signature of the informed consent by the patient or patients' legal tutors
- Age 18 to 55 years
- Diagnosis of a. Progressive MS as per the revised MC Donald 2010 criteria with a progressive course according to 2013 Lublin phenotypes classification (PMS) with failure or intolerance to all approved therapies according to the disease course or without any alternative approved therapy
- Evidence of progression of disease defined by an increase of ≥ 0.5 Expanded Disability Status Scale (EDSS) points in the last 12 months
- Disease duration 2 to 20 years (included)
- Expanded Disability Status Scale (EDSS) ≥ 6.5
- Presence of oligoclonal band in the cerebrospinal fluid (CSF) is required for Primary Progressive MS
Exclusion
- They will be excluded from the study patients:
- with any active or chronic infection or diseases other than MS including but not limited to infection with HIV1-2, Hepatitis B or Hepatitis C and tuberculosis or immune deficiency syndromes;
- treated with any immunosuppressive therapy, including but not limited to natalizumab and fingolimod, within the 3 months prior to screening;
- treated with interferon-beta or glatiramer acetate within the 30 days prior to screening;
- treated with corticosteroids within the 30 days prior to screening;
- if relapse occurred during the 30 days prior to screening;
- with contraindications for or intolerance to any medication, treatments and procedures that will be used in the study;
- pregnant or in lactation or of childbearing age who are not willing to use a contraceptive method effective\* for the entire duration of the study;
- who, in the opinion of the investigator, showing any condition that would preclude study participation.
- refer to guideline http://www.hma.eu/fileadmin/dateien/Human\_Medicines/01 About\_HMA/Working\_Groups/CTFG/2014\_09\_HMA\_CTFG\_Contraception.pdf
Key Trial Info
Start Date :
May 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03269071
Start Date
May 17 2017
End Date
July 31 2021
Last Update
September 5 2021
Active Locations (1)
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1
IRCCS Ospedale San Raffaele
Milan, MI, Italy, 20132