Ignite Creation Date:
2024-05-06 @ 10:06 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03164135
Status:
UNKNOWN
Last Update Posted:
2017-05-23
First Post:
2017-05-18
Brief Title:
Safety of Transplantation of CRISPR CCR5 Modified CD34 Cells in HIV-infected Subjects With Hematological Malignances
Sponsor:
Affiliated Hospital to Academy of Military Medical Sciences
Organization:
Affiliated Hospital to Academy of Military Medical Sciences
Study Overview
Official Title:
Safety and Feasibility Study of Allotransplantation of CRISPRCas9 CCR5 Gene Modified CD34 Hematopoietic StemProgenitor Cells in HIV-infected Subjects With Hematological Malignances
Status:
UNKNOWN
Status Verified Date:
2017-05
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 investigators performed this study to evaluate the safety and feasibility of transplantation with CRISPRCas9 CCR5 gene modified CD34 hematopoietic stemprogenitor cells for patients that develop AIDS and hematological malignances Patients will be treated with antiviral therapy ART to achieve undetectable HIV-1 virus in peripheral blood before conditioning CD34 cells from donors will be infused into the patients after treatment with CRISPRCas9 to ablate CCR5 gene
Detailed Description:
The primary objective of this study is to determine the safety of the infusion of CD34 cells which are treated with CRISPRCas9 to disrupt the CCR5 gene The secondary objective is to evaluate the resistance to HIV-1R5 in infected patients after infusion of modified CD34 cells with or without an antiretroviral therapy interruption ATI After the transplantation the reconstitution time and frequency of multi-lineage hematopoietic cell will be analyzed against previously reported HSCT in HIV-1 patients After the detection of high CD4 T cells reconstitution over 600 cellsĪ¼L and CCR5 negative cells over 1 in peripheral blood subjects will undergo an ATI HIV-1 RNA level and CD4 cell counts will be monitored biweekly for at least one month
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