Vascularized Composite Allotransplantation for Multiple Extremity Amputations
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Single, non-dominant hand amputees.
Active malignancy.
High risk of return of malignancy.
History of persistent non-compliance.
Trial design
Design model
Single group
Treatments tested in this trial
Limb transplantation
Procedure/Surgery
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: TransplantationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Outcomes of limb transplantation
We will undertake an objective evaluation of the results of limb transplantation in an "outcome-oriented" study
Time frame
Subjects will be followed for 18 months after transplantationSecondary outcomes
1
Efficacy and optimization of the immune suppression protocol
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.
Time frame
18 monthsSponsors and contacts
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Source ClinicalTrials.gov