Transplanting limbs from donors to patients with amputations
Vascularized Composite Allotransplantation for Multiple Extremity Amputations
This study is testing if transplanting limbs from donors to patients with amputations can improve their lives and how to make the process better for future patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT01293214 on ClinicalTrials.gov |
What this trial studies
This study focuses on limb transplantation surgery, where limbs from deceased donors are transferred to patients who have experienced single or multiple limb amputations. The research aims to establish best practices for multiple limb transplantation to enhance outcomes for future recipients. The team at Brigham and Women's Hospital, which includes various medical and surgical specialists, seeks to advance the science of limb transplantation and address challenges such as transplant rejection. Participants will undergo extensive evaluations and must commit to lifelong immunosuppressant therapy and rehabilitation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with single dominant hand or multiple limb amputations who have not found success with prosthetics.
Not a fit: Patients with non-dominant hand amputations or those with active malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could significantly improve the quality of life for amputees by restoring functionality and integration into society.
How similar studies have performed: Previous studies on limb transplantation have shown promise, but this approach is still considered innovative and under investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.