Ignite Creation Date:
2024-05-06 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03517631
Status:
UNKNOWN
Last Update Posted:
2020-02-19
First Post:
2018-03-20
Brief Title:
An Efficacy and Safety Study of shRNA-modified CD34 Cells in HIV-infected Patients
Sponsor:
Shanghai Public Health Clinical Center
Organization:
Shanghai Public Health Clinical Center
Study Overview
Official Title:
A Pilot Study to Evaluate Efficacy and Safety of Multiplexed shRNA-modified CD34 Cells in HIV-infected Patients
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
RECRUITING
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:
The purpose of the study is to evaluate the efficacy and safety of autologous CD34 cells that stably express multiplexed shRNA to treat HIV infection
Detailed Description:
CD34 cells will be isolated from mobilized PBMC of HIV patients The cells will be lentivirally transduced with multiplexed shRNAs in the same vector that target CCR5 and HIV genome Such modified cells will be infused back to the patients who have received bulsufan preconditioning before infusion The patients will then be evaluated for efficacy and safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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