NCT05655000

Neonatal Thymus Transplantation in Humans

A First-in-Humans Supermicrosurgical Technique for the Neonatal Thymus Transplantation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (estimated)
• Sponsor: Fundacion Clinica Valle del Lili · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to demonstrate the safety of the neonatal thymus transplant in an adult patient. The main questions it aims to answer are: * Is the neonatal thymus transplant a safe procedure? * What is the adverse event profile of the neonatal thymus transplant? This is a single-subject study; thus, there will not be comparison groups. The participant will receive multidisciplinary supportive care before, during, and after the procedure.

Detailed description

Inadequate thymopoiesis is probably related to autoimmunity, immunodeficiency, and immunosenescence. Enhancing thymopoiesis may be attractive for managing or studying such immunologic phenomena. Thymopoiesis is supported by the adult thymus transplant, as demonstrated in different animal models. Several approaches to enhance thymopoiesis in humans have been reported, which include in-vitro and in-vivo regeneration of the thymus and avascular grafting of allogeneic processed thymic tissue, among others. Although a supermicrosurgical technique for neonatal thymus transplantation was recently described in rabbits, it has never been described in humans. This technique can be used to perform a neonatal thymus transplantation in humans. If this technique demonstrates to be safe, future studies will follow to investigate its effect on thymopoiesis and its efficacy on different health conditions. This single-subject, first-in-humans clinical trial aims to demonstrate the safety and investigate the adverse effect profile of the neonatal thymus transplant in an adult with acute myeloid leukemia who is not candidate for bone marrow transplant, nor intensive chemotherapy. This human model not only allows to study the safety of the neonatal thymus transplant, it will also allow to investigate the effect of the procedure on thymopoiesis.

Conditions

• Safety Issues

Interventions

Type	Name	Description
PROCEDURE	Neonatal thymus transplantation	The donor's neonatal thymus vessels will be dissected right after the routinary partial thymectomy. These vessels will be anastomosed into the recipient's penetrating vessels within the radial forearm by using a supermicrosurgical technique. The graft will be explanted at day 14-21 after the procedure.

Timeline

• Start date: 2022-11-15
• Primary completion: 2022-12-01
• Completion: 2023-01-01
• First posted: 2022-12-16
• Last updated: 2022-12-16

Locations

1 site across 1 country: Colombia