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Vascularized Composite Allotransplantation for Multiple Extremity Amputations

StatusRecruiting
PhaseNot applicable
Started2010-02-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 48 months later Dec 31, 2026 → Dec 31, 2030
See other at-risk trials from Brigham and Women's Hospital

Amendment history

2026-10-02
Primary completion pushed: 2026-12-31 → 2030-12-31
Completion pushed: 2026-12-31 → 2030-12-31
2025-02-03
Study Status v15
Primary completion date2025-12-31→2026-12-31
Completion date2025-12-31→2026-12-31
2023-07-25
Study Status, Contacts/Locations v14
Study sitescontacts updated at 1 of 1 site
2022-07-18
Study Status v13
Primary completion date2021-12-31→2025-12-31
Completion date2021-12-31→2025-12-31
2021-07-20
Study Status v12
Primary completion date2020-12-30→2021-12-31
Completion date2020-12-30→2021-12-31
Show 11 earlier versions
2019-10-19
Study Status v11
Primary completion date2020-12→2020-12-30
Completion date2020-12→2020-12-30
Start date2010-02→2010-02-01
2018-07-18
Study Status, References v10
Re-verified, no change to tracked fields
2017-12-07
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations v9
Study sitescontacts updated at 1 of 1 site
2017-10-17
Study Identification, Study Status v8
Re-verified, no change to tracked fields
2017-03-20
Study Status v7
Primary completion date2016-12→2020-12
Completion date2016-12→2020-12
2016-07-18
2 amendments v5-v6
2 re-verifications since 2015-01-26, no change to tracked fields
2014-07-22
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, References v4
Primary completion date2014-08→2016-12
Completion date2015-02→2016-12
InterventionsHand transplantation (Procedure)→Limb transplantation (Procedure)
Eligibility criteria+7 characters
Inclusion Criteria: Age between 18 and 60 years. Single dominant hand or bilateralmultiple handlimb amputation. Time elapsed since amputation more than 6 months but less than 15 years. Patient has tried myoelectric 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 [...] stability. Any diagnosis that puts the subject at risk from handlimb transplant surgery or life-long immune suppression. Inabili [...]
Secondary endpoints5 to 1 entries
Procedural outcomes of hand transplantation Functional outcomes of hand transplantation Psychosocial outcomes of hand transplantation Financial and economic aspects of hand transplantation
Primary endpoints1 entry, revised
Outcomes of handlimb transplantation
Study description-2,513 characters
HandLimb transplantation surgery, the transfer of the handlimb(s) from a deceased human donor to a patient with amputation of one or bothmore handslimbss, is an experimental reconstructive procedure that has the potential to significantly improve the lives of hand amputees. HandLimb transplantation is similar to face transplantation in that [...] n, tendons, muscles, ligaments, bones and blood vessels. The hand transplant team at Brigham and Women's Hospital includes a [...] o provide amputee patients with the significant benefits of handlimb transplantation. Toward this goal, BWH is actively seeking qual [...] [...]
Publications2 to 5 entries
Bueno E, Benjamin MJ, Sisk G, Sampson CE, Carty M, Pribaz JJ, Pomahac B, Talbot SG. Rehabilitation following hand transplantation. Hand (N Y). 2014 Mar;9(1):9-15. doi: 10.1007/s11552-013-9568-8. Carty MJ, Zuker R, Cavadas P, Pribaz JJ, Talbot SG, Pomahac B. The case for lower extremity allotransplan [...]
Study title-1 characters
HandVascularized TransplantationComposite Allotransplantation for TreatmentMultiple ofExtremity Dominant Hand or Bilateral Hand AmputeesAmputations
2013-05-10
Study Status v3
Primary completion date2012-08→2014-08
2012-05-29
Study Status, Sponsor/Collaborators v2
Re-verified, no change to tracked fields
2011-07-11
Study Status, References v1
Publications1 to 2 entries
Pomahac B, Aflaki P. Composite tissue transplantation: a new era in transplantation surgery. Eplasty. 2010 Sep 15;10:e58.
2011-02-09
Original filing
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.
Trial Details
NCT Number NCT01293214
Lead Sponsor Brigham and Women's Hospital
Conditions Limb Amputation, Extremity Amputation
Enrollment 10 participants
Start Date 2010-02-01
Primary Completion 2030-12-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-10-01