Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Terminated

CT.gov ID

NCT00000917

Collaborator

(none)

200

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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 he/she 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Pregnancy

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 patient's 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 (e.g., 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 infant's 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 Design

Study Type:

Observational

Official Title:

Establishment of a Cord Blood Bank for Gene Therapy in HIV-Infected Infants

Study Start Date :

Sep 1, 1997

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 6 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

You may be eligible for this study if you:

Are HIV-positive.

Exclusion Criteria

Your child will not be eligible for this study if he/she:

Is not expected to live more than 6 months.
Weighs less than 3.3 pounds.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD Med Ctr / Pediatrics / Clinical Sciences	La Jolla	California	United States	920930672
2	Long Beach Memorial (Pediatric)	Long Beach	California	United States	90801
3	Los Angeles County - USC Med Ctr	Los Angeles	California	United States	90033
4	Cedars Sinai / UCLA Med Ctr	Los Angeles	California	United States	900481804
5	UCLA Med Ctr / Pediatric	Los Angeles	California	United States	900951752
6	Harbor - UCLA Med Ctr / UCLA School of Medicine	Los Angeles	California	United States	905022004
7	San Francisco Gen Hosp	San Francisco	California	United States	94110
8	UCSF / Moffitt Hosp - Pediatric	San Francisco	California	United States	941430105