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Safety Study of Human Neural Stem Cells Injections for Secondary Progressive Multiple Sclerosis Patients

NCT03282760 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-07-12

No results posted yet for this study

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 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.

Conditions

  • Secondary-progressive Multiple Sclerosis

Interventions

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.

Sponsors & Collaborators

  • Associazione Revert ONLUS

    collaborator UNKNOWN

  • Neurocenter of Southern Switzerland

    collaborator OTHER

  • Fondazione Cellule Staminali

    collaborator UNKNOWN

  • Casa Sollievo della Sofferenza IRCCS

    lead OTHER

Principal Investigators

  • Angelo L Vescovi, PhD · Casa Sollievo della Sofferenza IRCCS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-09
Primary Completion
2021-05-29
Completion
2021-05-29

Countries

  • Italy
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03282760 on ClinicalTrials.gov