Safety IssuesSUPERTHYMNCT05655000
Neonatal Thymus Transplantation in Humans
A study testing Neonatal thymus transplantation in people with Safety Issues, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Safety Issues
- What is being tested?
- Neonatal thymus transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteColombia
- Study dates
- 15 Nov 2022to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acute leukemia in palliative care, either myeloid (AML) or lymphocytic (ALL).
- Not candidate for bone marrow transplant.
- Not candidate for intensive chemotherapy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Fundación Valle Del Lili
Cali, Valle del Cauca Department, 760031
Luis F Tintinago-Londoño, MD, +573319090 ext. 7433, luis.tintinago@fvl.org.co
Luis F Tintinago-Londoño, MD
About this study
Official title: 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.
Read the 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
- Being tested
- Neonatal thymus transplantation
- Keywords
- Neonatal thymus transplant, First-in-humans, Clinical trial, Safety, Supermicrosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neonatal thymus transplantationProcedure or surgery
Also called Multidisciplinary supportive care before, during and after the procedure.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Neonatal thymus transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14-21 days
Secondary outcomes (3)
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.
Measured: 14-21 days
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.
Measured: 14-21 days
Donor-receptor compatibility
Human Leukocyte Antigens (HLA) typing.
Measured: 14-21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start15 Nov 2022
- Primary completionDec 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (96)Papers the sponsor has linked to this study.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinica Valle del Lili
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis F Tintinago-Londoño, MD, Principal investigator, Fundacion Clinica Valle del Lili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655000
- Sponsor's protocol ID
- FVL-1995
- Acronym
- SUPERTHYM
- Status last verified
- Dec 2022
- First submitted
- 24 Nov 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bluestone JA, Anderson M. Tolerance in the Age of Immunotherapy. N Engl J Med. 2020 Sep 17;383(12):1156-1166. doi: 10.1056/NEJMra1911109. No abstract available.
PubMed 32937048Collins C, Sharpe E, Silber A, Kulke S, Hsieh EWY. Congenital Athymia: Genetic Etiologies, Clinical Manifestations, Diagnosis, and Treatment. J Clin Immunol. 2021 Jul;41(5):881-895. doi: 10.1007/s10875-021-01059-7. Epub 2021 May 13.
PubMed 33987750Mittelbrunn M, Kroemer G. Hallmarks of T cell aging. Nat Immunol. 2021 Jun;22(6):687-698. doi: 10.1038/s41590-021-00927-z. Epub 2021 May 13.
PubMed 33986548Bredenkamp N, Ulyanchenko S, O'Neill KE, Manley NR, Vaidya HJ, Blackburn CC. An organized and functional thymus generated from FOXN1-reprogrammed fibroblasts. Nat Cell Biol. 2014 Sep;16(9):902-8. doi: 10.1038/ncb3023. Epub 2014 Aug 24.
PubMed 25150981Velardi E, Tsai JJ, Holland AM, Wertheimer T, Yu VW, Zakrzewski JL, Tuckett AZ, Singer NV, West ML, Smith OM, Young LF, Kreines FM, Levy ER, Boyd RL, Scadden DT, Dudakov JA, van den Brink MR. Sex steroid blockade enhances thymopoiesis by modulating Notch signaling. J Exp Med. 2014 Nov 17;211(12):2341-9. doi: 10.1084/jem.20131289. Epub 2014 Oct 20.
PubMed 25332287O'Neill KE, Bredenkamp N, Tischner C, Vaidya HJ, Stenhouse FH, Peddie CD, Nowell CS, Gaskell T, Blackburn CC. Foxn1 Is Dynamically Regulated in Thymic Epithelial Cells during Embryogenesis and at the Onset of Thymic Involution. PLoS One. 2016 Mar 16;11(3):e0151666. doi: 10.1371/journal.pone.0151666. eCollection 2016.
PubMed 26983083Ulyanchenko S, O'Neill KE, Medley T, Farley AM, Vaidya HJ, Cook AM, Blair NF, Blackburn CC. Identification of a Bipotent Epithelial Progenitor Population in the Adult Thymus. Cell Rep. 2016 Mar 29;14(12):2819-32. doi: 10.1016/j.celrep.2016.02.080. Epub 2016 Mar 17.
PubMed 26997270Martin-Gayo E, Gonzalez-Garcia S, Garcia-Leon MJ, Murcia-Ceballos A, Alcain J, Garcia-Peydro M, Allende L, de Andres B, Gaspar ML, Toribio ML. Spatially restricted JAG1-Notch signaling in human thymus provides suitable DC developmental niches. J Exp Med. 2017 Nov 6;214(11):3361-3379. doi: 10.1084/jem.20161564. Epub 2017 Sep 25.
PubMed 28947612Shichkin VP, Gorbach OI, Zuieva OA, Grabchenko NI, Aksyonova IA, Todurov BM. Effect of cryopreservation on viability and growth efficiency of stromal-epithelial cells derived from neonatal human thymus. Cryobiology. 2017 Oct;78:70-79. doi: 10.1016/j.cryobiol.2017.06.010. Epub 2017 Jun 28.
PubMed 28668447Garcia-Leon MJ, Fuentes P, de la Pompa JL, Toribio ML. Dynamic regulation of NOTCH1 activation and Notch ligand expression in human thymus development. Development. 2018 Aug 13;145(16):dev165597. doi: 10.1242/dev.165597.
PubMed 30042180Campinoti S, Gjinovci A, Ragazzini R, Zanieri L, Ariza-McNaughton L, Catucci M, Boeing S, Park JE, Hutchinson JC, Munoz-Ruiz M, Manti PG, Vozza G, Villa CE, Phylactopoulos DE, Maurer C, Testa G, Stauss HJ, Teichmann SA, Sebire NJ, Hayday AC, Bonnet D, Bonfanti P. Reconstitution of a functional human thymus by postnatal stromal progenitor cells and natural whole-organ scaffolds. Nat Commun. 2020 Dec 11;11(1):6372. doi: 10.1038/s41467-020-20082-7.
PubMed 33311516Fahy GM. Apparent induction of partial thymic regeneration in a normal human subject: a case report. J Anti Aging Med. 2003;6(3):219-27. doi: 10.1089/109454503322733063.
PubMed 14987435Fahy GM, Brooke RT, Watson JP, Good Z, Vasanawala SS, Maecker H, Leipold MD, Lin DTS, Kobor MS, Horvath S. Reversal of epigenetic aging and immunosenescent trends in humans. Aging Cell. 2019 Dec;18(6):e13028. doi: 10.1111/acel.13028. Epub 2019 Sep 8.
PubMed 31496122Kirkpatrick JA Jr, DiGeorge AM. Congenital absence of the thymus. Am J Roentgenol Radium Ther Nucl Med. 1968 May;103(1):32-7. doi: 10.2214/ajr.103.1.32. No abstract available.
PubMed 5648947Conley ME, Beckwith JB, Mancer JF, Tenckhoff L. The spectrum of the DiGeorge syndrome. J Pediatr. 1979 Jun;94(6):883-90. doi: 10.1016/s0022-3476(79)80207-3.
PubMed 448529
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Humans Supermicrosurgical Technique for the Neonatal Thymus Transplantation
- ClinicalTrials.gov ID
- NCT05655000
- Acronym / sponsor ID
- SUPERTHYM / FVL-1995
- Conditions
- Safety Issues
- Keywords
- Neonatal thymus transplant, First-in-humans, Clinical trial, Safety, Supermicrosurgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Fundacion Clinica Valle del LiliUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Neonatal thymus transplantation | Experimental | Procedure: Neonatal thymus transplantationSupermicrosurgical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of acute leukemia in palliative care, either myeloid (AML) or lymphocytic (ALL).
- Not candidate for bone marrow transplant.
- Not candidate for intensive chemotherapy.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neonatal thymus transplantationAlso: Multidisciplinary supportive care before, during and after the procedure.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. | Procedure or surgery | Neonatal thymus transplantation |
Primary outcome
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.
3 secondary outcomes
Thymic graft functioning
Time frame: 14-21 days
Tissue viability
Time frame: 14-21 days
Donor-receptor compatibility
Time frame: 14-21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Background: PubMed 32937048Bluestone JA, Anderson M. Tolerance in the Age of Immunotherapy. N Engl J Med. 2020 Sep 17;383(12):1156-1166. doi: 10.1056/NEJMra1911109. No abstract available.
- Background: PubMed 33987750Collins C, Sharpe E, Silber A, Kulke S, Hsieh EWY. Congenital Athymia: Genetic Etiologies, Clinical Manifestations, Diagnosis, and Treatment. J Clin Immunol. 2021 Jul;41(5):881-895. doi: 10.1007/s10875-021-01059-7. Epub 2021 May 13.
- Background: PubMed 33986548Mittelbrunn M, Kroemer G. Hallmarks of T cell aging. Nat Immunol. 2021 Jun;22(6):687-698. doi: 10.1038/s41590-021-00927-z. Epub 2021 May 13.
- Background: PubMed 25150981Bredenkamp N, Ulyanchenko S, O'Neill KE, Manley NR, Vaidya HJ, Blackburn CC. An organized and functional thymus generated from FOXN1-reprogrammed fibroblasts. Nat Cell Biol. 2014 Sep;16(9):902-8. doi: 10.1038/ncb3023. Epub 2014 Aug 24.
- Background: PubMed 25332287Velardi E, Tsai JJ, Holland AM, Wertheimer T, Yu VW, Zakrzewski JL, Tuckett AZ, Singer NV, West ML, Smith OM, Young LF, Kreines FM, Levy ER, Boyd RL, Scadden DT, Dudakov JA, van den Brink MR. Sex steroid blockade enhances thymopoiesis by modulating Notch signaling. J Exp Med. 2014 Nov 17;211(12):2341-9. doi: 10.1084/jem.20131289. Epub 2014 Oct 20.
- Background: PubMed 26983083O'Neill KE, Bredenkamp N, Tischner C, Vaidya HJ, Stenhouse FH, Peddie CD, Nowell CS, Gaskell T, Blackburn CC. Foxn1 Is Dynamically Regulated in Thymic Epithelial Cells during Embryogenesis and at the Onset of Thymic Involution. PLoS One. 2016 Mar 16;11(3):e0151666. doi: 10.1371/journal.pone.0151666. eCollection 2016.
- Background: PubMed 26997270Ulyanchenko S, O'Neill KE, Medley T, Farley AM, Vaidya HJ, Cook AM, Blair NF, Blackburn CC. Identification of a Bipotent Epithelial Progenitor Population in the Adult Thymus. Cell Rep. 2016 Mar 29;14(12):2819-32. doi: 10.1016/j.celrep.2016.02.080. Epub 2016 Mar 17.
- Background: PubMed 28947612Martin-Gayo E, Gonzalez-Garcia S, Garcia-Leon MJ, Murcia-Ceballos A, Alcain J, Garcia-Peydro M, Allende L, de Andres B, Gaspar ML, Toribio ML. Spatially restricted JAG1-Notch signaling in human thymus provides suitable DC developmental niches. J Exp Med. 2017 Nov 6;214(11):3361-3379. doi: 10.1084/jem.20161564. Epub 2017 Sep 25.
- Background: PubMed 28668447Shichkin VP, Gorbach OI, Zuieva OA, Grabchenko NI, Aksyonova IA, Todurov BM. Effect of cryopreservation on viability and growth efficiency of stromal-epithelial cells derived from neonatal human thymus. Cryobiology. 2017 Oct;78:70-79. doi: 10.1016/j.cryobiol.2017.06.010. Epub 2017 Jun 28.
- Background: PubMed 30042180Garcia-Leon MJ, Fuentes P, de la Pompa JL, Toribio ML. Dynamic regulation of NOTCH1 activation and Notch ligand expression in human thymus development. Development. 2018 Aug 13;145(16):dev165597. doi: 10.1242/dev.165597.
- Background: PubMed 33311516Campinoti S, Gjinovci A, Ragazzini R, Zanieri L, Ariza-McNaughton L, Catucci M, Boeing S, Park JE, Hutchinson JC, Munoz-Ruiz M, Manti PG, Vozza G, Villa CE, Phylactopoulos DE, Maurer C, Testa G, Stauss HJ, Teichmann SA, Sebire NJ, Hayday AC, Bonnet D, Bonfanti P. Reconstitution of a functional human thymus by postnatal stromal progenitor cells and natural whole-organ scaffolds. Nat Commun. 2020 Dec 11;11(1):6372. doi: 10.1038/s41467-020-20082-7.
- Background: PubMed 14987435Fahy GM. Apparent induction of partial thymic regeneration in a normal human subject: a case report. J Anti Aging Med. 2003;6(3):219-27. doi: 10.1089/109454503322733063.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis F Tintinago-Londoño, MD principal investigator
Fundacion Clinica Valle del Lili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neonatal thymus transplantation in people with Safety Issues, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis F Tintinago-Londoño, MD (+573319090 ext. 7433, luis.tintinago@fvl.org.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: 14-21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05655000, which also lists 96 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.