NCT01293214 Vascularized Composite Allotransplantation for Multiple Extremity Amputations
| NCT ID | NCT01293214 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brigham and Women's Hospital |
| Condition | Limb Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2010-02-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2010-02-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Frequently Asked Questions
Who can join the NCT01293214 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Limb Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01293214 currently recruiting?
Yes, NCT01293214 is actively recruiting participants. Visit ClinicalTrials.gov or contact Brigham and Women's Hospital to inquire about joining.
Where is the NCT01293214 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT01293214 clinical trial?
NCT01293214 is sponsored by Brigham and Women's Hospital. The trial plans to enroll 10 participants.