Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000917
Status:
TERMINATED
Last Update Posted:
2008-08-01
First Post:
1999-11-02
Brief Title:
Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Establishment of a Cord Blood Bank for Gene Therapy in HIV-Infected Infants
Status:
TERMINATED
Status Verified Date:
2003-06
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:
The purpose of this study is to set up a blood bank for infants who have HIV-positive mothers This blood may be used in the future to treat the child if heshe turns out to be HIV-positive
Blood from the umbilical cord contains a certain kind of cell called a stem cell Stem cells eventually turn into one of the many types of blood cells If HIV infection can be prevented in these stem cells then when these stem cells are injected back into the infant the new cells that develop will also be protected from HIV This study will provide the blood needed to test whether this type of gene therapy is safe and effective
Blood from the umbilical cord contains a certain kind of cell called a stem cell Stem cells eventually turn into one of the many types of blood cells If HIV infection can be prevented in these stem cells then when these stem cells are injected back into the infant the new cells that develop will also be protected from HIV This study will provide the blood needed to test whether this type of gene therapy is safe and effective
Detailed Description:
Gene therapy may provide a new therapeutic approach to pediatric AIDS Putting an HIV-resistant gene into umbilical cord blood stem cells and transplanting the cells back into the patient could lead to the production of cells that resist HIV infection If a patients cells could be engineered to be resistant to supporting the growth of HIV-1 the cells may have improved survival in the presence of HIV-1 To date an umbilical cord blood bank for HIV-positive deliveries has not been established in the United States This protocol establishes a repository of banked umbilical cord blood as a first step toward the potential application of gene therapy for the treatment of HIV-infected infants
HIV-infected mothers have about 20 ml of blood drawn to test for infectious diseases eg hepatitis At time of delivery maternal HIV viral load is measured After delivery about 60 ml of blood is collected from the umbilical cord this blood is labeled and transferred to the umbilical cord blood bank for possible use in future gene therapy studies on the infant At birth infant HIV status and general health are assessed If the infant is found to be HIV-infected the mother may be approached about the infants participation in a future gene therapy study If the infant is not HIV-infected the cord blood is stored for up to four years and is then released to the mother or with her consent to the research community
HIV-infected mothers have about 20 ml of blood drawn to test for infectious diseases eg hepatitis At time of delivery maternal HIV viral load is measured After delivery about 60 ml of blood is collected from the umbilical cord this blood is labeled and transferred to the umbilical cord blood bank for possible use in future gene therapy studies on the infant At birth infant HIV status and general health are assessed If the infant is found to be HIV-infected the mother may be approached about the infants participation in a future gene therapy study If the infant is not HIV-infected the cord blood is stored for up to four years and is then released to the mother or with her consent to the research community
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: