Ignite Creation Date:
2024-05-05 @ 11:58 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01461837
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2011-10-19
Brief Title:
Haplo T-Cell Depleted Transplantation in High-Risk Sickle Cell Disease
Sponsor:
New York Medical College
Organization:
New York Medical College
Study Overview
Official Title:
Familial Haploidentical T-Cell Depleted Transplantation in High-Risk Sickle Cell Disease IND 14359
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
HaploSCD
Brief Summary:
This study is being done to determine the safety and outcome long-term control of a high-dose chemotherapy regimen followed by an infusion of CD34 selected immune cells stem cells from a partially matched adult family member donor called haploidentical stem cell transplantation in high-risk sickle cell disease patients
Funding Source - FDA OOPD
Funding Source - FDA OOPD
Detailed Description:
The purpose of this study is to investigate host myeloimmunosuppressive conditioning followed by familial haploidentical T cell depleted allogeneic stem cell transplantation in patients with high risk Sickle Cell Disease SCD It is hypothesized that it will be safe and well tolerated and result in sustained donor chimerism acceptable engraftment and immune reconstitution Also that it will limit SCD related organ damage resulting in improved andor stable neurological neurocognitive pulmonary and pulmonary vascular function and health related quality of life QOL
Patients 2-2099 years of age with a diagnosis of high-risk SCD and with an unaffected HLA partially matched family donor and meeting eligibility criteria inclusion and exclusion criteria are eligible
Patients 2-2099 years of age with a diagnosis of high-risk SCD and with an unaffected HLA partially matched family donor and meeting eligibility criteria inclusion and exclusion criteria are eligible
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 |
|---|---|---|---|
| FD-R-0004090 | OTHER_GRANT | FDA OOPD | None |