Subcutaneous transplantation of human thyroid tissue into a pre-vascularized Cell Pouch™ device in a Mus musculus model: Evidence of viability and function for thyroid transplantation.

This study aimed to investigate the survival and efficacy indicators of human thyroid tissue transplantation into a retrievable, prevascularized implanted Sernova Corp Cell Pouch™ (CP) device. Thyroid tissue from human donors was transplanted subcutaneously into the pre-implanted CP device or into the subcutaneous (SC) space alone as a control in a nude Mus musculus model. Transplanted M. musculus were monitored for human serum thyroglobulin (TG) levels for 3 months until the transplants were removed for histological assessment. Human thyroid tissue survived and continued to produce TG in transplanted nude M. musculus in the CP, with no adverse events. CP transplants exhibited more persistent and robust production of human TG than tissue placed in the SC space alone from 3 to 13 weeks post transplantation. Fresh thyroid transplants had better survival and function compared to cryopreserved transplants. Thyroid transplant viability correlated with TG levels at 3 months post-transplant (p = 0.03). Immunofluorescence staining of transplants for TG and TPO localized in thyroid follicles. Human thyroid tissue transplanted into the subcutaneously implanted pre-vascularized CP in nude M. musculus survived and continued to produce robust and persistent human TG and warrants further investigation as a treatment for postoperative hypothyroidism.
Competing Interests: I have read the journal’s policy and the following authors of this manuscript have the following competing interests. Some of the authors of this study have a commercial affiliation with Sernova Corp as described here: SMW serves on the scientific advisory board of Sernova Corp and received an honorarium from Sernova Corp for drafting and delivery of a KOL online lecture. AM is employed as a Research Scientist at Sernova Corp and receives salary & benefits. DMM was employed as the Senior Director of R&D and Clinical Programs of Sernova Corp and received salary & benefits when this work was carried out. PMT is the President and CEO of Sernova Corp and receives salary & benefits. All other co-authors listed have declared that no competing interests exist.