Status:
COMPLETED
Safety Study of Human Neural Stem Cells Injections for Secondary Progressive Multiple Sclerosis Patients
Lead Sponsor:
Casa Sollievo della Sofferenza IRCCS
Collaborating Sponsors:
Associazione Revert ONLUS
Neurocenter of Southern Switzerland
Conditions:
Secondary-progressive Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This will be a phase I, open, multicenter, international study performed by 3 participating centres across two countries (Italy and Switzerland). Fifteen to 24 patients affected by SPMS will be enroll...
Eligibility Criteria
Inclusion
- SPMS with progressive accumulation of disability after initial relapsing course, with or without disease activity (Lublin et al. 2014).
- EDSS ≥ 6.5 and ≤ 8
- EDSS progression over the 2 years prior to study start of ≥ 1.0 point for patients with EDSS =6.5 at the time of inclusion , and of ≥ 0.5 points for patients with EDSS \> 6.5 at the time of inclusion
- Age ≥ 18 and ≤ 60 years
- Failure of best medical treatment as judged by the treating neurologist and declared absence of therapeutic alternatives
Exclusion
- Neurological conditions other than MS.
- Psychiatric disorders, severe cognitive decline and personality and relational disorders.
- History or known presence of significant systemic, infectious, oncologic or metabolic disorders.
- Presence of any other autoimmune disease.
- Chronic infections (HBV, HCV, HIV, tuberculosis).
- Inability to perform MRI scans.
- Immunomodulant/immunosuppressive treatments in the last 6 months before inclusion.
- Current participation to other experimental studies.
- Inability to provide informed consent.
- Any contra-indication to lumbar puncture and the surgical procedure (e.g. use of anticoagulants)
- Pregnancy and breast feeding.
Key Trial Info
Start Date :
September 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03282760
Start Date
September 9 2017
End Date
May 29 2021
Last Update
July 12 2021
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Casa Sollievo della Sofferenza - IRCCS
San Giovanni Rotondo, Foggia, Italy, 71013
2
Azienda Ospedaliera Santa Maria di Terni
Terni, Italy, 05100
3
Neurocentro della Svizzera Italiana, Istituto di Neurosienze cliniche della svizzera italiana, Centro sclerosi Multipla
Lugano, Switzerland, 6900