Thymus Transplantation in DiGeorge Syndrome #668

PHASE2CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

October 31, 1991

Primary Completion Date

April 30, 2009

Study Completion Date

December 31, 2017

Conditions
DiGeorge SyndromeComplete Typical DiGeorge Anomaly
Interventions
BIOLOGICAL

Cultured Thymus Tissue for Implantation (CTTI)

Cultured thymus tissue for implantation (CTTI) (previously described as transplantation) is done using allogeneic cultured postnatal tissue from unrelated thymus donors. Thymus tissue, the thymus donor, \& thymus donor's birth mother were screened for safety. Approximately 2-3 weeks post-harvest thymus slices were implanted into the recipient's quadriceps. Dose was number of grams of cultured thymus tissue divided by the recipient's weight in kilograms. Minimum dose was 4 g/m2. Maximum dose 18g/m2. At time of CTTI, a skin biopsy was obtained to look for preexisting T cells. 2-3 months post-CTTI allograft biopsy to evaluate for thymopoiesis \& graft rejection. At time of biopsy, skin biopsy done to look for T cell clonal populations. Post-CTTI, subjects followed by routine research immune evaluations, using blood samples for approximately 2 years.

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