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Vascularized Composite Allotransplantation

Limb Transplantation for Amputation

N/A

Recruiting

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willing to take immunosuppressants - drugs that help prevent rejection of the transplant - for life.

Level of amputation anywhere from the wrist (or ankle) joint to just below the shoulder (or hip) joint, which should be functional.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Study Summary

This trial is testing the best practices for multiple limb transplantation to improve the outcomes for future recipients.

Who is the study for?

This trial is for adults aged 18-60 who have lost one or more limbs, from the wrist/ankle to just below the shoulder/hip, and haven't had success with prosthetics. They must be willing to undergo psychological evaluation, vaccinations, take lifelong immunosuppressants, commit to a minimum of two years of rehab post-transplant, and attend follow-up visits. Not eligible if they have active cancer risks or mental instability that affects treatment compliance.Check my eligibility

What is being tested?

The study is testing limb transplantation from deceased donors to patients with amputations. It aims to develop best practices for this procedure in order to improve outcomes for those receiving multiple limb transplants.See study design

What are the potential side effects?

Potential side effects include complications related to surgery such as infection or blood clots; challenges with transplant rejection requiring lifelong use of immunosuppressive drugs which can increase infection risk and cause other systemic issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to take drugs for life to prevent transplant rejection.

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My amputation is between my wrist and shoulder or ankle and hip, and it's functional.

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I am committed to following a strict rehabilitation program for at least two years after my transplant.

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I am between 18 and 60 years old.

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My amputation was between 6 months and 15 years ago.

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I have lost either my dominant hand or multiple limbs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Outcomes of limb transplantation

Secondary outcome measures

Efficacy and optimization of the immune suppression protocol

Trial Design

1Treatment groups

Experimental Treatment

Group I: TransplantationExperimental Treatment1 Intervention

Subjects will undergo single or multiple limb transplantation

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,612 Previous Clinical Trials

11,470,565 Total Patients Enrolled

Media Library

Limb Transplantation (Vascularized Composite Allotransplantation) Clinical Trial Eligibility Overview. Trial Name: NCT01293214 — N/A

Amputation Research Study Groups: Transplantation

Amputation Clinical Trial 2023: Limb Transplantation Highlights & Side Effects. Trial Name: NCT01293214 — N/A

Limb Transplantation (Vascularized Composite Allotransplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01293214 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible for enrollment in this medical study?

"Entry into this medical trial necessitates amputation and that the patient is within 18–60 years of age. This study requires approximately 10 participants to meet its requirements."

Answered by AI

Does this research trial accept individuals who are 45 years of age or older?

"Per the study's requirements, candidates must be aged 18-60 to partake in this clinical trial."

Answered by AI

Are there any remaining opportunities to participate in this research endeavor?

"As per clinicaltrials.gov, this trial is presently enrolling participants. The initial posting occurred on February 1st 2010 and the most recent update was released July 18th 2022."

Answered by AI

What is the current enrollment capacity for this research project?

"Affirmative. Clinicaltrials.gov records showcase that this medical trial, initially posted on February 1st 2010, is actively recruiting patients for the study. Ten participants are sought after from a single site location."

Answered by AI