Trial | NCT03282760  Report issue

Title

Safety Study of Human Neural Stem Cells Injections for Secondary Progressive Multiple Sclerosis Patients
A Phase I Multicenter Study of Allogenic, Intracerebroventricular Human Neural Stem Cells Transplantation for the Experimental Treatment of Secondary Progressive Multiple Sclerosis Patients

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    24
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 enrolled, according to a "standard" phase I design over 18 months. All patients will enter a 3 months run in phase. Thereafter they will receive one of four different doses of allogenic hNSCs (dose A=5 millions hNSCs; dose B=10 millions hNSCs; dose C=16 millions hNSCs; dose D=24 millions hNSCs). Following hNSCs injection, all SPMS patients will receive immunosuppression with tacrolimus for 6 months. Patients will be clinically followed monthly for 1 year and then every 6 months for the 5 years following the study completion (possibly all life long).

MRI assessments will be performed monthly for the first 6 months and then every 3 months for 5 years following the study completion.
Study Started
Sep 09
2017
Primary Completion
May 29
2021
Study Completion
May 29
2021
Last Update
Jul 12
2021

Biological Human Neural Stem Cells

Allogenic human Neural Stem Cells (hNSCs) in four different dosages (5, 10, 16 or 24 millions). hNSCs are produced by the Laboratorio Cellule Staminali of Terni according to GMP guidelines and are obtained from brain specimens of several fetal human donors from spontaneous miscarriages occurred after the 8th week after conception.

Human Neural Stem Cells Suspension Experimental

Intraventricular injections of Allogenic human Neural Stem Cells (hNSCs) in four different dosages (5, 10,16 or 24 millions)

Criteria 

Inclusion Criteria:

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 Criteria:

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.
No Results Posted