Actively Recruiting
Vascularized Composite Allotransplantation for Multiple Extremity Amputations
Led by Brigham and Women's Hospital · Updated on 2025-02-05
10
Participants Needed
1
Research Sites
882 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vascularized Composite Allotransplantation for Multiple Extremity Amputations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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