Neonatal Thymus Transplantation in Humans
- Conditions
- Safety Issues
- Interventions
- Procedure: Neonatal thymus transplantation
- Registration Number
- NCT05655000
- Lead Sponsor
- Fundacion Clinica Valle del Lili
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1
- Diagnosis of acute leukemia in palliative care, either myeloid (AML) or lymphocytic (ALL).
- Not candidate for bone marrow transplant.
- Not candidate for intensive chemotherapy.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Neonatal thymus transplantation 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.
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) 14-21 days Incidence of AEs and of clinically relevant changes in vital signs values, symptoms, physical examination findings, laboratory and imaging safety data.
- Secondary Outcome Measures
Name Time Method Thymic graft functioning 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.
Tissue viability 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.
Donor-receptor compatibility 14-21 days Human Leukocyte Antigens (HLA) typing.
Trial Locations
- Locations (1)
Fundación Valle Del Lili
🇨🇴Cali, Valle Del Cauca, Colombia