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New treatment option for Limb Amputation
Official title Vascularized Composite Allotransplantation for Multiple Extremity Amputations
ClinicalTrials.gov ID: NCT01293214
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.