Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646640
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Long Term Follow-Up Study for Individuals With Hemoglobin Disorders After Hematopoietic Stem Cell Transplant or Gene Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Long Term Follow-Up Study for Individuals With Hemoglobin Disorders After Hematopoietic Stem Cell Transplant or Gene Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective longitudinal non-therapeutic study which includes routine assessment for long-term effects as per FDA guidelines after receipt of an allogeneic HSCT or autologous genetically modified cellular products for hemoglobin disorders
Primary objective
- To provide long term follow up for individuals with hemoglobin disorders undergoing allogeneic hematopoietic stem cell transplantation HSCT or receipt of an autologous genetically modified cellular product to treat their hemoglobinopathy For individuals receiving a genetically modified cellular product this long term follow up study is in accordance with the guidelines provided by the Food and Drug Administration FDA
Primary objective
- To provide long term follow up for individuals with hemoglobin disorders undergoing allogeneic hematopoietic stem cell transplantation HSCT or receipt of an autologous genetically modified cellular product to treat their hemoglobinopathy For individuals receiving a genetically modified cellular product this long term follow up study is in accordance with the guidelines provided by the Food and Drug Administration FDA
Detailed Description:
This protocol will provide a mechanism to appropriately monitor individuals with hemoglobin disorders that have received an allogenic HSCT or an autologous genetically modified cellular product for hemoglobinopathies Monitoring will include potential long-term adverse effects after receipt of these treatments as well as long-term monitoring after the receipt of the genetically modified cellular product
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