11
Participants
Start Date
August 31, 2014
Primary Completion Date
August 31, 2023
Study Completion Date
August 31, 2023
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."
Blood Draw
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.
Sumitomo Pharma Switzerland GmbH
INDUSTRY