Ignite Creation Date:
2024-05-06 @ 2:52 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02140554
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2014-05-14
Brief Title:
A Study Evaluating the Safety and Efficacy of Lovo-cel in Severe Sickle Cell Disease
Sponsor:
bluebird bio
Organization:
bluebird bio
Study Overview
Official Title:
A Phase 12 Study Evaluating Gene Therapy by Transplantation of Autologous CD34 Stem Cells Transduced Ex Vivo With the LentiGlobin BB305 Lentiviral Vector in Subjects With Severe Sickle Cell Disease
Status:
COMPLETED
Status Verified Date:
2024-09
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 is a non-randomized open label multi-site single dose Phase 12 study in approximately 50 adults and adolescents with severe SCD The study will evaluate hematopoietic stem cell HSC transplantation HSCT using lovo-cel
Detailed Description:
Subject participation for this study will be 2 years post-transplant Subjects who enroll in this study will be asked to participate in a subsequent long-term follow up study that will monitor the safety and efficacy of the treatment they receive for an additional 13 years for a total of 15 years post-drug product infusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None