Neonatal Thymus Transplantation in Humans (SUPERTHYM)

December 14, 2022 updated by: Fundacion Clinica Valle del Lili

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Colombia
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760031
        • Recruiting
        • Fundacion Valle del Lili
        • Contact:
        • Principal Investigator:
          • Luis F Tintinago-Londoño, MD
        • Sub-Investigator:
          • Francisco J Jaramillo-Echeverry, MD PhD-c
        • Sub-Investigator:
          • Sergio I Prada-Ríos, MSc MPA PhD
        • Sub-Investigator:
          • William Victoria-Morales, MD
        • Sub-Investigator:
          • Juan F Vélez-Moreno, MD
        • Sub-Investigator:
          • Juan C Arias-Millán, MD
        • Sub-Investigator:
          • Hugo D Campos-Martínez, MD
        • Sub-Investigator:
          • Alejandro Sandoval-Daza, MD
        • Sub-Investigator:
          • Nhora M Silva-Pérez, MD
        • Sub-Investigator:
          • Juan C Bravo-Ocaña, MD
        • Sub-Investigator:
          • Daniel F Isaza-Pierotti, MD MCSO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neonatal thymus transplantation
Supermicrosurgical technique for neonatal thymus transplantation into the subject's radial forearm. The donor will be a neonate subject to corrective heart surgery via sternotomy requiring routinary partial thymectomy.
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.
Other Names:
  • Multidisciplinary supportive care before, during and after the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: 14-21 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thymic graft functioning
Time Frame: 14-21 days
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
Tissue viability
Time Frame: 14-21 days
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
Donor-receptor compatibility
Time Frame: 14-21 days
Human Leukocyte Antigens (HLA) typing.
14-21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Clinica Valle del Lili

Investigators

  • Principal Investigator: Luis F Tintinago-Londoño, MD, Fundacion Clinica Valle del Lili

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

November 24, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Actual)

December 16, 2022

Study Record Updates

Last Update Posted (Actual)

December 16, 2022

Last Update Submitted That Met QC Criteria

December 14, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FVL-1995

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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