Ignite Creation Date:
2024-05-06 @ 12:55 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03887273
Status:
RECRUITING
Last Update Posted:
2023-08-21
First Post:
2019-03-14
Brief Title:
Study to Investigate the Safety of the Transplantation of Human Glial Restricted Progenitor Cells Into Subjects With Transverse Myelitis
Sponsor:
Q Therapeutics Inc
Organization:
Q Therapeutics Inc
Study Overview
Official Title:
A Phase 12a Open-Label Study to Investigate the Safety of the Transplantation by Injection of Human Glial Restricted Progenitor Cells hGRPs Q-Cells Into Subjects With Transverse Myelitis TM
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Idiopathic Transverse Myelitis is a monophasic disorder characterized predominantly by demyelination Patients are left with disability from damage to ascending and descending white matter tracts Q-Cells are comprised of glial progenitor cellsIt is postulated that the Q-Cells glial progeny healthy astrocytes and oligodendrocytes will integrate into the spinal cord lesion site and remyelinate demyelinated axons as well as provide trophic support for damaged axons Therefore Q-Cells have the potential to repair damage that has occurred and could be clinically useful for patients with disability caused by TM
The study is planned to enroll up to 9 subjects Each subject will be followed for 9 months after transplantation of Q-Cells Each subject will receive a single time point administration of Q-Cells with transplantation foci targeted to posterior columns in the spinal cord all transplantation foci below C7 on one side
Study participation consists of Screening Pre-operativeTreatment and Post-treatment study periods that will generally last from 9 to 12 months in total The study data will be assessed for safety and activity until the last subject has completed the 9-month study visit Following completion of the 9-month follow-up period subjects who consent will continue to be followed for safety and activity in a separate long-term follow-up protocol
Idiopathic Transverse Myelitis is a monophasic disorder characterized predominantly by demyelination Patients are left with disability from damage to ascending and descending white matter tracts Q-Cells are comprised of glial progenitor cellsIt is postulated that the Q-Cells glial progeny healthy astrocytes and oligodendrocytes will integrate into the spinal cord lesion site and remyelinate demyelinated axons as well as provide trophic support for damaged axons Therefore Q-Cells have the potential to repair damage that has occurred and could be clinically useful for patients with disability caused by TM
The study is planned to enroll up to 9 subjects Each subject will be followed for 9 months after transplantation of Q-Cells Each subject will receive a single time point administration of Q-Cells with transplantation foci targeted to posterior columns in the spinal cord all transplantation foci below C7 on one side
Study participation consists of Screening Pre-operativeTreatment and Post-treatment study periods that will generally last from 9 to 12 months in total The study data will be assessed for safety and activity until the last subject has completed the 9-month study visit Following completion of the 9-month follow-up period subjects who consent will continue to be followed for safety and activity in a separate long-term follow-up protocol
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None