Hand Transplantation for Functional Recovery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether hand transplants can help individuals who have lost a hand above the wrist regain function. The focus is on determining if the transplanted hand remains healthy and usable over five years. Participants should have severe hand damage where prosthetics prove ineffective and must commit to long-term treatment and follow-up care. This procedure is known as Upper Extremity Vascularized Composite Allotransplantation (VCA). As an unphased trial, the study offers participants a unique opportunity to contribute to groundbreaking research that could transform future treatment options.
What prior data suggests that this protocol is safe for hand transplantation?
Research has shown that transplanting a hand or arm, known as upper extremity vascularized composite allotransplantation (VCA), offers promising results for improving function and sensation. Studies have found that recipients often experience better movement and feeling, enhancing their quality of life.
However, VCA is a complex procedure with significant risks. Past data indicate instances of losing the transplanted limb and some deaths, often due to rejection or infection. Participants in these studies needed medications to prevent their immune system from attacking the new limb, which can cause side effects.
In summary, while VCA offers potential benefits, participants must be aware of the risks and the need for ongoing medical care.12345Why are researchers excited about this trial?
Researchers are excited about Upper Extremity Vascularized Composite Allotransplantation (VCA) because it offers a completely new approach to hand transplantation. Unlike traditional prosthetics or hand reconstruction surgeries, VCA involves transplanting not just skin and muscle, but also bone, nerves, and blood vessels from a donor, creating a more natural and functional limb. This method has the potential to restore a wide range of movement and sensation in the transplanted hand, which current options can't achieve. Additionally, VCA utilizes a standardized protocol, which could lead to more consistent and successful outcomes in patients.
What evidence suggests that upper extremity vascularized composite allotransplantation is effective for functional recovery?
Research has shown that transplanting a new arm or hand can greatly improve the quality of life for individuals who have lost a limb. In this trial, participants will undergo Upper Extremity Vascularized Composite Allotransplantation (VCA) to assess its impact on restoring feeling and movement, enabling the use of their hands again. Success stories highlight not only improved hand function but also enhanced mental and physical well-being after the transplant. Experiences from around the world support these benefits, demonstrating promising results in both function and appearance.14678
Who Is on the Research Team?
Bohdan Pomahac, MD
Principal Investigator
Yale University
Vijay Gorantla, MD, PhD, FRCS
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
This trial is for adults who have lost a hand or arm and are considering a hand transplant. Participants should be healthy enough for major surgery and long-term medication, and must not have conditions that would make the procedure unsafe.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Initial Hospitalization
Participants undergo upper extremity vascularized composite allotransplantation and are monitored weekly during initial hospitalization
Post-Surgery Monitoring
Participants are monitored for allograft survival and acute rejection incidence with regular assessments
Long-term Follow-up
Participants are monitored for safety, functional outcomes, and psychosocial outcomes annually
What Are the Treatments Tested in This Trial?
Interventions
- Upper Extremity Vascularized Composite Allotransplantation (VCA)
Trial Overview
The study is testing the safety, function, and psychological effects of hand or arm transplantation (VCA) over five years. All participants receive the transplant following a standardized protocol.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Upper Extremity VCA performed under a standardized CONSORT clinical protocol. The study utilizes a longitudinal cohort design where each participant serves as their own control pre and post transplant.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
Wake Forest University Health Sciences
Collaborator
Citations
Perceived Success in Upper-Extremity Vascularized ...
Vascularized composite allotransplantation has emerged as a revolutionary treatment option for anatomical restoration after severe disfigurement or amputation.
lessons learned from hand transplantation and implications ...
The main goal of VCA of the extremity is to improve quality of life via restoration of sensation and motor function after limb loss. All viable ...
Vascularized Composite Allotransplantation of the Hand ...
The purpose of the trial is to study functional, psychological, and immunological outcomes of human upper extremity allotransplantation. Detailed Description.
Building a Hand and Upper Extremity Transplantation Program
The emerging field of vascularized composite allotransplantation (VCA) offers promising functional and aesthetic outcomes when compared with conventional ...
Outcomes after hand and upper extremity transplantation
This review will discuss the current state of HUET, summarizing outcome data on graft survival, motor and sensory function, as well as ...
Measuring Health-Related Quality of Life in Upper ...
The current standard outcomes included in the International Registry on Hand and Composite Tissue Transplantation are limited to 1 self-report measure—the
VCA Background Information and Context - NCBI
Based on data reported hand VCA recipients showed improvement in their quantitative function scores, DASH scores, and the sensory recovery test after hand ...
essential factors for upper extremity transplant program ...
Vascularized Composite Allotransplantation (VCA) offers a unique option to restore form and function after limb loss or facial trauma that cannot be ...
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