Neural Stem Cell Transplantation in Multiple Sclerosis Patients

• Status: Completed
• Trial end date: 2021-07-31
• Target enrollment: 0
• Participant gender: All

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 5.7x10^6±10% cells/kg of body weight, in patients affected by Progressive Multiple Sclerosis

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS San Raffaele
• Collaborator: Fondazione Italiana Sclerosi Multipla

Criteria

Inclusion Criteria:

1. Signature of the informed consent by the patient or patients' legal tutors

2. Age 18 to 55 years

3. 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

4. Evidence of progression of disease defined by an increase of ≥ 0.5 Expanded Disability Status Scale (EDSS) points in the last 12 months

5. Disease duration 2 to 20 years (included)

6. Expanded Disability Status Scale (EDSS) ≥ 6.5

7. Presence of oligoclonal band in the cerebrospinal fluid (CSF) is required for Primary Progressive MS

Exclusion Criteria:

They will be excluded from the study patients:

1. 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;

2. treated with any immunosuppressive therapy, including but not limited to natalizumab and fingolimod, within the 3 months prior to screening;

3. treated with interferon-beta or glatiramer acetate within the 30 days prior to screening;

4. treated with corticosteroids within the 30 days prior to screening;

5. if relapse occurred during the 30 days prior to screening;

6. with contraindications for or intolerance to any medication, treatments and procedures that will be used in the study;

7. 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;

8. 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