Neonatal Thymus Transplantation hos mennesker (SUPERTHYM)
14. december 2022 opdateret af: Fundacion Clinica Valle del Lili
En første-i-menneskelig supermikrokirurgisk teknik til neonatal thymustransplantation
Målet med dette kliniske forsøg er at demonstrere sikkerheden ved neonatal thymustransplantation hos en voksen patient. De vigtigste spørgsmål, den sigter mod at besvare er:
- Er neonatal thymustransplantation en sikker procedure?
- Hvad er bivirkningsprofilen for den neonatale thymustransplantation?
Dette er et enkeltfagsstudie; således vil der ikke være sammenligningsgrupper. Deltageren vil modtage tværfaglig støttende behandling før, under og efter proceduren.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Utilstrækkelig thymopoiese er sandsynligvis relateret til autoimmunitet, immundefekt og immunosenescens. Forstærkning af thymopoiese kan være attraktivt til at håndtere eller studere sådanne immunologiske fænomener. Thymopoiesis understøttes af den voksne thymustransplantation, som vist i forskellige dyremodeller. Adskillige tilgange til at forbedre thymopoiesis hos mennesker er blevet rapporteret, som omfatter in vitro og in vivo regenerering af thymus og avaskulær podning af allogent behandlet thymusvæv, blandt andre.
Selvom en supermikrokirurgisk teknik til neonatal thymustransplantation for nylig blev beskrevet hos kaniner, er den aldrig blevet beskrevet hos mennesker. Denne teknik kan bruges til at udføre en neonatal thymustransplantation hos mennesker. Hvis denne teknik viser sig at være sikker, vil fremtidige undersøgelser følge for at undersøge dens effekt på thymopoiesis og dens effekt på forskellige sundhedstilstande.
Dette enkelt-fags første-i-menneske kliniske forsøg har til formål at demonstrere sikkerheden og undersøge bivirkningsprofilen af den neonatale thymustransplantation hos en voksen med akut myeloid leukæmi, som ikke er kandidat til knoglemarvstransplantation eller intensiv kemoterapi. Denne menneskelige model gør det ikke kun muligt at studere sikkerheden ved den neonatale thymustransplantation, den vil også gøre det muligt at undersøge virkningen af proceduren på thymopoiesis.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
1
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Luis F Tintinago-Londoño, MD
- Telefonnummer: 7433 +573319090
- E-mail: luis.tintinago@fvl.org.co
Studiesteder
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Valle Del Cauca
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Cali, Valle Del Cauca, Colombia, 760031
- Rekruttering
- Fundacion Valle del Lili
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Kontakt:
- Luis F Tintinago-Londoño, MD
- Telefonnummer: 7433 +573319090
- E-mail: luis.tintinago@fvl.org.co
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Ledende efterforsker:
- Luis F Tintinago-Londoño, MD
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Underforsker:
- Francisco J Jaramillo-Echeverry, MD PhD-c
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Underforsker:
- Sergio I Prada-Ríos, MSc MPA PhD
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Underforsker:
- William Victoria-Morales, MD
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Underforsker:
- Juan F Vélez-Moreno, MD
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Underforsker:
- Juan C Arias-Millán, MD
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Underforsker:
- Hugo D Campos-Martínez, MD
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Underforsker:
- Alejandro Sandoval-Daza, MD
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Underforsker:
- Nhora M Silva-Pérez, MD
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Underforsker:
- Juan C Bravo-Ocaña, MD
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Underforsker:
- Daniel F Isaza-Pierotti, MD MCSO
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
16 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Diagnose af akut leukæmi i palliativ pleje, enten myeloid (AML) eller lymfocytisk (ALL).
- Ikke kandidat til knoglemarvstransplantation.
- Ikke kandidat til intensiv kemoterapi.
Ekskluderingskriterier:
- Tidligere sygehistorie med knoglemarvstransplantation.
- Tidligere sygehistorie med alvorlig kognitiv svækkelse eller demens.
- Tidligere sygehistorie med alvorlig leversvigt.
- Tidligere sygehistorie med kronisk nyresygdom (CKD) stadium 4-5.
- Tidligere sygehistorie med akut koronarsyndrom inden for de seneste 90 dage.
- Tidligere sygehistorie med akut iskæmisk slagtilfælde inden for de seneste 90 dage.
- Tidligere sygehistorie med dekompenseret kongestiv hjerteinsufficiens (CHF) inden for de seneste 90 dage.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Neonatal thymustransplantation
Supermikrokirurgisk teknik til neonatal thymustransplantation i forsøgspersonens radiale underarm.
Donoren vil være en nyfødt, der skal gennemgå korrigerende hjertekirurgi via sternotomi, hvilket kræver rutinemæssig delvis thymektomi.
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Donorens neonatale thymuskar vil blive dissekeret lige efter den rutinemæssige partielle thymektomi.
Disse kar vil blive anastomoseret ind i modtagerens penetrerende kar i den radiale underarm ved hjælp af en supermikrokirurgisk teknik.
Graftet vil blive eksplanteret på dag 14-21 efter proceduren.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Hyppighed af uønskede hændelser (AE'er)
Tidsramme: 14-21 dage
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Forekomst af AE'er og af klinisk relevante ændringer i vitale tegnværdier, symptomer, fysiske undersøgelsesresultater, laboratorie- og billeddannelsessikkerhedsdata.
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14-21 dage
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Funktion af thymustransplantat
Tidsramme: 14-21 dage
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Ændring i procent (%) af naive (CD45+ CD3+ CDRA+) og hukommelse (CD45+ CD3+ CDRA-) T-lymfocytter i forhold til det samlede antal T-lymfocytter ved flowcytometri før engrafting (dag -1) og før eksplantation (dag +14-21) ), som biomarkører for thymopoiesis.
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14-21 dage
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Vævs levedygtighed
Tidsramme: 14-21 dage
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Tilstedeværelse og omfang (hvis nogen) af transplantatafstødningen ved lysmikroskopi med eosin-hæmatoxylin og immunokemifarvning i det eksplanterede thymusvæv på postoperativ dag 14-21.
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14-21 dage
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Donor-receptor kompatibilitet
Tidsramme: 14-21 dage
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Typering af humane leukocytantigener (HLA).
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14-21 dage
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Luis F Tintinago-Londoño, MD, Fundacion Clinica Valle del Lili
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- Markert ML, Marques JG, Neven B, Devlin BH, McCarthy EA, Chinn IK, Albuquerque AS, Silva SL, Pignata C, de Saint Basile G, Victorino RM, Picard C, Debre M, Mahlaoui N, Fischer A, Sousa AE. First use of thymus transplantation therapy for FOXN1 deficiency (nude/SCID): a report of 2 cases. Blood. 2011 Jan 13;117(2):688-96. doi: 10.1182/blood-2010-06-292490. Epub 2010 Oct 26.
- 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.
- Collins 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.
- Mittelbrunn 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.
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- O'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.
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- Albuquerque AS, Marques JG, Silva SL, Ligeiro D, Devlin BH, Dutrieux J, Cheynier R, Pignata C, Victorino RM, Markert ML, Sousa AE. Human FOXN1-deficiency is associated with alphabeta double-negative and FoxP3+ T-cell expansions that are distinctly modulated upon thymic transplantation. PLoS One. 2012;7(5):e37042. doi: 10.1371/journal.pone.0037042. Epub 2012 May 10.
- Davies EG, Cheung M, Gilmour K, Maimaris J, Curry J, Furmanski A, Sebire N, Halliday N, Mengrelis K, Adams S, Bernatoniene J, Bremner R, Browning M, Devlin B, Erichsen HC, Gaspar HB, Hutchison L, Ip W, Ifversen M, Leahy TR, McCarthy E, Moshous D, Neuling K, Pac M, Papadopol A, Parsley KL, Poliani L, Ricciardelli I, Sansom DM, Voor T, Worth A, Crompton T, Markert ML, Thrasher AJ. Thymus transplantation for complete DiGeorge syndrome: European experience. J Allergy Clin Immunol. 2017 Dec;140(6):1660-1670.e16. doi: 10.1016/j.jaci.2017.03.020. Epub 2017 Apr 8.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. november 2022
Primær færdiggørelse (Forventet)
1. december 2022
Studieafslutning (Forventet)
1. januar 2023
Datoer for studieregistrering
Først indsendt
24. november 2022
Først indsendt, der opfyldte QC-kriterier
14. december 2022
Først opslået (Faktiske)
16. december 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. december 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. december 2022
Sidst verificeret
1. december 2022
Mere information
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Nøgleord
Andre undersøgelses-id-numre
- FVL-1995
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