Thymus Transplantation With Immunosuppression

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

July 31, 2002

Primary Completion Date

December 31, 2006

Study Completion Date

December 31, 2019

Conditions
DiGeorge SyndromeDiGeorge AnomalyComplete DiGeorge AnomalyComplete DiGeorge Syndrome
Interventions
BIOLOGICAL

Thymus Tissue for Transplantation

"3 Thymoglobulin doses given prior to thymus tx. Atypical subjects given Cyclosporine (Csa) pre-tx. Desired Csa concentration 180-300ng/ml. If post-tx T cell count remained \<4000/cumm Csa weaned over 8 weeks. If T cell \>4,000/cumm, Csa held at 180-300ng/ml.~Thymus tissue, donor, \& mother of donor were screened for transplant safety. In operating room, thymic slices were transplanted into quadriceps muscle in 1 or both legs.~Subjects had routine blood research immune evaluations. 2-3 months post-tx, open biopsy of allograft. Immune blood studies continued on surviving subjects until January 2010. Biological Mother: Mother provided blood sample used for DNA extraction, to identify/look for maternal T cell presence in recipient pre-tx, and/or for immune testing post-tx."

Trial Locations (1)

27710

Duke University Medical Center, Durham

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Sumitomo Pharma Switzerland GmbH

INDUSTRY

NCT00579709 - Thymus Transplantation With Immunosuppression | Biotech Hunter | Biotech Hunter