Study to Investigate the Safety of the Transplantation of Human Glial Restricted Progenitor Cells Into Subjects With Transverse Myelitis

Part of paid clinical trials in Dallas, Texas.

Sponsor
Q Therapeutics, Inc.
Study ID
NCT03887273
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Transverse Myelitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Q-Cells — BIOLOGICAL
    Cellular therapeutic comprised of human cells of the glial lineage

Study Details

This study is a non-randomized, open-label, partially blinded, sequential cohort, dose-escalation study designed to obtain preliminary data on the safety, tolerability, and early activity of Q-Cells® transplantation in subjects with Transverse Myelitis. For each of the dose levels, transplantation of Q-Cells® unilaterally into spinal cord demyelinated lesions will be evaluated. Subjects will be blinded to side of treatment.

Key Dates

First listed
Mar 22, 2019
Start date
Sep 20, 2022
Status verified
Jul 2026
Primary completion
Jul 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
9 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Q-Cells dose level 1
    One time surgical transplantation of Q-Cells dose level 1 unilaterally into spinal cord demyelinated lesion
  • Experimental: Q-Cells dose level 2
    One time surgical transplantation of Q-Cells dose level 2 unilaterally into spinal cord demyelinated lesion
  • Experimental: Q-Cells dose level 3
    One time surgical transplantation of Q-Cells dose level 3 unilaterally into spinal cord demyelinated lesion

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]. [ Time Frame: 9-months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
Taylor Hinojo
214-645-3230
Benjamin Greenberg, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Texas Southwestern Medical Center· Dallas, TX

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