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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 July 2021 |
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Main ID: |
NCT03282760 |
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Date of registration:
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09/08/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety Study of Human Neural Stem Cells Injections for Secondary Progressive Multiple Sclerosis Patients
NSC-SPMS |
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Scientific title:
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A Phase I Multicenter Study of Allogenic, Intracerebroventricular Human Neural Stem Cells Transplantation for the Experimental Treatment of Secondary Progressive Multiple Sclerosis Patients |
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Date of first enrolment:
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September 9, 2017 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03282760 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Italy
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Switzerland
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Contacts
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Name:
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Angelo L Vescovi, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Casa Sollievo della Sofferenza IRCCS |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. SPMS with progressive accumulation of disability after initial relapsing course, with
or without disease activity (Lublin et al. 2014).
2. EDSS = 6.5 and = 8
3. 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
4. Age = 18 and = 60 years
5. Failure of best medical treatment as judged by the treating neurologist and declared
absence of therapeutic alternatives
Exclusion Criteria:
1. Neurological conditions other than MS.
2. Psychiatric disorders, severe cognitive decline and personality and relational
disorders.
3. History or known presence of significant systemic, infectious, oncologic or metabolic
disorders.
4. Presence of any other autoimmune disease.
5. Chronic infections (HBV, HCV, HIV, tuberculosis).
6. Inability to perform MRI scans.
7. Immunomodulant/immunosuppressive treatments in the last 6 months before inclusion.
8. Current participation to other experimental studies.
9. Inability to provide informed consent.
10. Any contra-indication to lumbar puncture and the surgical procedure (e.g. use of
anticoagulants)
11. Pregnancy and breast feeding.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Secondary-progressive Multiple Sclerosis
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Intervention(s)
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Biological: Human Neural Stem Cells
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Primary Outcome(s)
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Incidence of Treatment Emergent AE
[Time Frame: 1 year]
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Percentage of Mortality in treated patients
[Time Frame: 1 year]
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Secondary Outcome(s)
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Change in Functional disability
[Time Frame: Up to 1 year]
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MS Biomarkers
[Time Frame: Up to 1 year]
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Alteration in Neurophysiological parameters
[Time Frame: Up to 1 year]
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Activity of Cognitive function
[Time Frame: Up to 1 year]
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Relapses Rate
[Time Frame: Up to 1 year]
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Secondary ID(s)
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2015-004855-37
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NSC SPMS
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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