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Allotransplantation composite vascularisée pour amputations multiples de membres

29 septembre 2026 mis à jour par: Simon George Talbot, Brigham and Women's Hospital

Limb transplantation surgery is the transfer of one or more limbs from a deceased human donor to a patient with single or multiple limb amputation. Hand transplantation is an innovative reconstructive procedure that has the potential to significantly improve the lives of hand amputees. The purpose of this study is to develop the best practices for multiple limb transplantation that will improve the outcomes of future limb transplant recipients.

Aperçu de l'étude

Statut

Recrutement

Intervention / Traitement

Description détaillée

Limb transplantation surgery, the transfer of the limb(s) from a deceased human donor to a patient with amputation of one or more limbss, is an experimental reconstructive procedure that has the potential to significantly improve the lives of amputees.

Limb transplantation is similar to face transplantation in that the tissues transplanted include skin, tendons, muscles, ligaments, bones and blood vessels. The transplant team at Brigham and Women's Hospital includes a wide variety of medical and surgical specialties. The team hopes to build upon the success of their first face transplantation to provide amputee patients with the significant benefits of limb transplantation.

Toward this goal, BWH is actively seeking qualified candidates for the limb transplant research study. We will be studying a small group of people to learn more about:

  • How to advance the science of limb transplantation
  • How to support and limit transplant rejection issues
  • How people do after limb transplantation

We describe limb transplant surgery as a life-giving procedure because it has the potential to dramatically improve, that is to restore, both a patient's mental and physical health and his/her ability to function and integrate in society. However, as with any other type of organ transplantation, this improvement will require the patient to make a lifetime commitment to taking medications that suppress the body's immune system.

Conventional reconstruction methods are always considered first, but they may provide less than optimal results for certain patients. There are many sophisticated prostheses that satisfactorily replace the basic function of a missing limb. However, replacing limbs (in whole or in part) with prosthetics remains suboptimal in that prostheses do not provide sensation and do not have a natural appearance. Limbtransplant surgery, however, has the potential to deliver these desired functional and aesthetic benefits. Functionally, limb transplant surgery can provide a patient with new limbs that, after extensive rehabilitation, allow him/her to perform daily activities and, in most cases, return to work. Furthermore, the ability to restore a near-normal aesthetic appearance of the limb(s) can lead to tremendous psychological benefits, including elevated confidence and mood.

From the time we begin our search for a qualified limb transplant recipient to the continuing care we provide following surgery, a significant amount of time, expertise and attentiveness is contributed toward making the procedure a progressive success. Limb transplant candidates go through an extensive screening process that is likely to last several months. This screening includes a psychiatric and social support evaluation and a series of imaging tests to help determine a patient's physical and mental readiness for the procedure. If, upon completion of the screening process, it is determined that a patient is a suitable candidate, we will place the patient on a transplant waiting list. We will then begin working with the New England Organ Bank (NEOB) team to find a donor who matches the recipient's tissue requirements - for example similar age and correct blood type. This search could take many months, and, if a suitable donor is not found within one year, we will speak with the patient to determine whether he/she is willing to continue waiting.

Type d'étude

Interventionnel

Inscription (Estimé)

10

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02115
        • Recrutement
        • Brigham and Women's Hospital
        • Chercheur principal:
          • Simon Talbot, M.D.
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 60 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Age between 18 and 60 years.
  • Single dominant hand or multiple limb amputation.
  • Time elapsed since amputation more than 6 months but less than 15 years.
  • Patient has tried prosthesis without success.
  • Level of amputation anywhere from the wrist (or ankle) joint to just below the shoulder (or hip) joint, which should be functional.
  • Signed written informed consent.
  • Willing to complete psychological and social evaluations.
  • Willing to take immunosuppressants - drugs that help prevent rejection of the transplant - for life.
  • Willing to comply with extensive post-transplant rehabilitation for a minimum of two years.
  • Willing to return for follow-up visits as determined by the treating physician.
  • Willing to receive standard vaccinations prior to the transplant, such as influenza and hepatitis B.

Exclusion Criteria:

  • Single, non-dominant hand amputees.
  • Active malignancy.
  • High risk of return of malignancy.
  • History of persistent non-compliance.
  • Findings of psychological evaluation that indicate inability to comply with physician's orders or mental instability.
  • Any diagnosis that puts the subject at risk from limb transplant surgery or life-long immune suppression.
  • Inability to ensure adequate follow-up of post-transplant care and immune suppression.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Transplantation

Subjects will undergo single or multiple limb transplantation

Autres noms:
  • allogreffe composite vascularisée

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Outcomes of limb transplantation
Délai: Subjects will be followed for 18 months after transplantation

We will undertake an objective evaluation of the results of limb transplantation in an "outcome-oriented" study

Subjects will be followed for 18 months after transplantation

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Efficacy and optimization of the immune suppression protocol
Délai: 18 months

We will evaluate the risks of rejection or likelihood of tolerance induction by measuring specific parameters in the blood or tissue, including: Serum alloantibodies concentration, numbers/phenotype of specific T cell alloreactivity in the peripheral blood, phenotypic characterization of graft infiltrating cells and local gene expression of cells and cytokines.

18 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 février 2010

Achèvement primaire (Estimé)

31 décembre 2030

Achèvement de l'étude (Estimé)

31 décembre 2030

Dates d'inscription aux études

Première soumission

9 février 2011

Première soumission répondant aux critères de contrôle qualité

9 février 2011

Première publication (Estimé)

10 février 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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