NCT05655000

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2022

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

December 16, 2022

Status Verified

December 1, 2022

Enrollment Period

16 days

First QC Date

November 24, 2022

Last Update Submit

December 14, 2022

Conditions

Safety Issues

Keywords

Neonatal thymus transplantFirst-in-humansClinical trialSafetySupermicrosurgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Thymic graft functioning

    14-21 days

  • Tissue viability

    14-21 days

  • Donor-receptor compatibility

    14-21 days

Study Arms (1)

Neonatal thymus transplantation

EXPERIMENTAL

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

Interventions

Neonatal thymus transplantationPROCEDURE

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.

Also known as: Multidisciplinary supportive care before, during and after the procedure.
Neonatal thymus transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Valle Del Lili

Cali, Valle del Cauca Department, 760031, Colombia

RECRUITING

Related Publications (96)

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Study Officials

  • Luis F Tintinago-Londoño, MD

    Fundacion Clinica Valle del Lili

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis F Tintinago-Londoño, MD

CONTACT

+573319090luis.tintinago@fvl.org.co

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single-subject study of a supermicrosurgical technique for neonatal thymus transplantation in an adult with acute myeloid leukemia who is not candidate for bone marrow transplant, nor intensive chemotherapy. The participant will receive multidisciplinary supportive care before, during and after the procedure. The safety and adverse event profile will be assessed throughout the study. The graft will be explanted 14-21 days after the procedure. Thymopoiesis will be measured at baseline and at postoperatve day 14-21, before explantation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2022

First Posted

December 16, 2022

Study Start

November 15, 2022

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

December 16, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)