Expanded Access Protocol Thymus Transplantation

PHASE4CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

August 31, 2023

Study Completion Date

August 31, 2023

Conditions
Poor Thymic FunctionImmunodeficiencyAthymiaImmunoreconstitutionThymus TransplantationLow T Cell Numbers
Interventions
BIOLOGICAL

Cultured Thymus Tissue

"Subjects receive cultured thymus tissue which is implanted into the quadriceps muscle. Subjects may receive pre and/or post-implantation immunosuppression.~Potential subjects are screened for eligibility. The thymus tissue (from an unrelated donor), the donor, and the donor's mother are screened for safety. Cultured thymus tissue is implanted into the subject's quadriceps muscle under general anesthesia in the operating room. Two to three months post-implantation, if medically stable, subjects may undergo an allograft biopsy. Subjects undergo laboratory testing for approximately one year post-implantation. At year 2 post-implantation, subjects are contacted for data collection."

PROCEDURE

Blood Draw

DRUG

Rabbit Anti-Thymocyte Globulin and Cyclosporine or Tacrolimus

RATGAM and Cyclosporine or Tacrolimus may be given, depending on the patient. The doses, timing, and trough levels will vary depending on the patient's clinical condition.

All Listed Sponsors
lead

Sumitomo Pharma Switzerland GmbH

INDUSTRY

NCT02274662 - Expanded Access Protocol Thymus Transplantation | Biotech Hunter | Biotech Hunter