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Neural Stem Cell Transplantation in Multiple Sclerosis Patients

NCT03269071 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-09-05

No results posted yet for this study

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

Conditions

Interventions

DRUG

human fetal-derived Neural Stem Cells (hNSCs)

The Drug Product (DP) can be classified as an ATIMP belonging to the class of Cell Therapy Medicinal Products (EU law). The ATIMP consists of human fetal-derived Neural Stem Cells (hNSCs) re-suspended in their final formulation medium as defined in the Investigational Medical Product Dossier (IMPD). For dosage indications, see specific Treatment Cohorts (TC), from A to D. The product will be administered intrathecally through lumbar puncture.

Sponsors & Collaborators

  • Fondazione Italiana Sclerosi Multipla

    collaborator OTHER

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Gianvito Martino · IRCCS San Raffaele

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2017-05-17
Primary Completion
2021-07-31
Completion
2021-07-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT03269071 on ClinicalTrials.gov