Neonatal Thymus Transplantation in Humans

Safety Issues Clinical Trial

— SUPERTHYM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05655000
• Other study ID #: FVL-1995
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: January 2023

Study information

• Verified date: December 2022
• Source: Fundacion Clinica Valle del Lili
• Contact: Luis F Tintinago-Londoño, MD
• Phone: +573319090
• Email: luis.tintinago[@]fvl.org.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: January 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of acute leukemia in palliative care, either myeloid (AML) or lymphocytic (ALL).
• Not candidate for bone marrow transplant.
• Not candidate for intensive chemotherapy.

Exclusion Criteria:

• Past medical history of bone marrow transplant.
• Past medical history of severe cognitive decline or dementia.
• Past medical history of severe liver failure.
• Past medical history of chronic kidney disease (CKD) stage 4-5.
• Past medical history of acute coronary syndrome within the past 90 days.
• Past medical history of acute ischemic stroke within the past 90 days.
• Past medical history of decompensated congestive heart failure (CHF) within the past 90 days.

Related Conditions & MeSH terms

• Safety Issues

Intervention

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.

Locations

Country	Name	City	State
Colombia	Fundación Valle Del Lili	Cali	Valle Del Cauca

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinica Valle del Lili

Country where clinical trial is conducted

Colombia, 

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* Note: There are 96 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)	Incidence of AEs and of clinically relevant changes in vital signs values, symptoms, physical examination findings, laboratory and imaging safety data.	14-21 days
Secondary	Thymic graft functioning	Change in percentage (%) of naïve (CD45+ CD3+ CDRA+) and memory (CD45+ CD3+ CDRA-) T lymphocytes over the total number of T lymphocytes by flow cytometry before engrafting (day -1), and before explant (day +14-21), as biomarkers of thymopoiesis.	14-21 days
Secondary	Tissue viability	Presence and extent (if any) of the graft rejection by light microscopy with eosin-hematoxylin and immunochemistry staining in the explanted thymic tissue at post-operative day 14-21.	14-21 days
Secondary	Donor-receptor compatibility	Human Leukocyte Antigens (HLA) typing.	14-21 days