Study to Investigate the Safety of the Transplantation (by Injection) of Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) Into Subjects With Amyotrophic Lateral Sclerosis (ALS)

Sponsor
Q Therapeutics, Inc.
Study ID
NCT02478450
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
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 efficacy of Q-Cells® transplantation in subjects with ALS. Following an initial cohort receiving cell transplants unilaterally in the lumbar spinal cord, subsequent cohorts will receive escalating doses transplanted unilaterally in cervical spinal cord. Subjects and outcome measure assessors will be blinded to side of treatment. The study will be conducted at sites with extensive clinical experience with the care of patients with ALS.

Key Dates

First listed
Jun 23, 2015
Start date
Dec 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Unilateral lumbar surgical transplantation of Q-Cells dose level 1
  • Experimental: Cohort 2
    Unilateral cervical surgical transplantation of Q-Cells dose level 1
  • Experimental: Cohort 3
    Unilateral cervical surgical transplantation of Q-Cells dose level 2
  • Experimental: Cohort 4
    Unilateral cervical surgical transplantation of Q-Cells dose level 3
  • Experimental: Cohort 5
    Unilateral cervical surgical transplantation of Q-Cells dose level 4
  • Experimental: Cohort 6
    Unilateral cervical surgical transplantation of Q-Cells dose level 5

Primary Outcome Measure

Safety of human glial restricted progenitor cell transplantation in patients with Amyotrophic Lateral Sclerosis. (adverse events) [ Time Frame: 9-month ]

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