Ignite Creation Date:
2024-05-06 @ 9:13 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02931071
Status:
COMPLETED
Last Update Posted:
2020-05-27
First Post:
2016-09-06
Brief Title:
Clinical Phase II Trial to Evaluate CD34 Cells Mobilization and Collection in Patients With Fanconi Anemia for Subsequent Transduction With a Lentiviral Vector Carring FANCA Gene FANCOSTEM-1
Sponsor:
Hospital Universitari Vall dHebron Research Institute
Organization:
Hospital Universitari Vall dHebron Research Institute
Study Overview
Official Title:
Clinical Phase II Trial to Evaluate Efficacy and Safety of CD34 Cells Mobilization and Collection After Treatment With Plerixafor and Filgrastim in Patients With Fanconi Anemia for Subsequent Transduction With a Lentiviral Vector Carring FANCA Gene and Reinfusion in the Patient
Status:
COMPLETED
Status Verified Date:
2020-05
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:
Fanconi anemia FA is a congenital disease characterized by bone marrow failure and increased incidence of malignant tumors The Project pursue the optimization of the collection of hematopoietic progenitor cells for later use in another clinical trial entitled Clinical Trial Phase III to evaluate the safety and efficacy of the infusion of autologous CD34 cells mobilized with mozobil and filgrastim and transduced with a lentiviral vector carrying the FANCA gene Orphan Drug for patients with Fanconi Anemia Subtype A The objectives of this study are therefore to assess the safety and efficacy of CD34 cells mobilization with mozobil and filgrastim which is postulated the most efficient for the collection of CD34 cells from FA patients
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-006197-88 | EUDRACT_NUMBER | None | None |