Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163508
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-29
First Post:
2023-11-14
Brief Title:
A Long Term Follow-Up Study for Subjects Who Have Received Q-Cells
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
A Long Term Follow-Up Study for Subjects Who Have Received Human Glial Restricted Progenitor Cells hGRPs Q-Cells LTFU Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
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 an observational study designed to obtain information on the long-term safety tolerability and continued activity of Q-Cells The study will follow the participants who previously received Q-Cells for 10 years
The goal of this observational study is to learn about the long term effects of Q-Cells in people with transverse myelitis
The main objectives the study is to evaluate the safety of patients who have received Q-Cells
The secondary goal of the study is to get data about the long-term activity of Q-Cells over a period of 10 years
Patients will complete exams lab tests imaging and questionnaires to monitor their safety
The goal of this observational study is to learn about the long term effects of Q-Cells in people with transverse myelitis
The main objectives the study is to evaluate the safety of patients who have received Q-Cells
The secondary goal of the study is to get data about the long-term activity of Q-Cells over a period of 10 years
Patients will complete exams lab tests imaging and questionnaires to monitor their safety
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