Ignite Creation Date:
2024-05-06 @ 1:13 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03964792
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-09
First Post:
2019-05-14
Brief Title:
Safety and Efficacy of Gene Therapy of the Sickle Cell Disease by Transplantation of an Autologous CD34 Enriched Cell Fraction That Contains CD34 Cells Transduced ex Vivo With the GLOBE1 Lentiviral Vector Expressing the βAS3 Globin Gene in Patients With Sickle Cell Disease DREPAGLOBE
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
A Phase 12 Open Label Study Evaluating the Safety and Efficacy of Gene Therapy of the Sickle Cell Disease by Transplantation of an Autologous CD34 Enriched Cell Fraction That Contains CD34 Cells Transduced ex Vivo With the GLOBE1 Lentiviral Vector Expressing the βAS3 Globin Gene GLOBE1 βAS3 Modified Autologous CD34 Cells in Patients With Sickle Cell Disease SCD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
DREPAGLOBE
Brief Summary:
The purpose of this study is to evaluate the Safety and Efficacy of Gene Therapy of the Sickle Cell disease by Transplantation of an Autologous CD34 enriched cell fraction that contains CD34 cells transduced ex vivo with the GLOBE1 lentiviral vector expressing the βAS3 globin gene GLOBE1 βAS3 Modified Autologous CD34 Cells in Patients with Sickle Cell Disease SCD
Detailed Description:
None
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