RecruitingPhase 2NCT01459107

Human Upper Extremity Allotransplantation

Sponsor

Johns Hopkins University

Enrollment

30 participants

Start Date

Jul 21, 2011

Study Type

INTERVENTIONAL

Conditions

Hand injuries Wounds and Injuries Amputation, Traumatic

Summary

Background: Millions of people each year sustain injuries, have tumors surgically removed, or are born with defects that require complex reconstructive surgeries to repair. In the case of hand, forearm, or arm amputation, prostheses only provide less than optimal motor function and no sensory feedback. However, hand and arm transplantation is a means to restore the appearance, anatomy, and function of a native hand. Although over 70 hand transplants have been performed to date and good functional results have been achieved, widespread clinical use has been limited due to adverse effects of life-long and high-dose immunosuppression needed to prevent graft rejection. Risks include infection, cancer, and metabolic problems, all of which can greatly affect recipients' quality of life, make the procedure riskier, and jeopardize the potential benefits of hand transplantation. Study Design: This non-randomized, Phase II clinical trial will document the use of a new immunomodulatory protocol (aka - Pittsburgh Protocol, Starzl Protocol) for establishing hand transplantation as a safe and effective reconstructive treatment for upper extremity amputations by minimizing maintenance immunosuppression therapy in unilateral and bilateral hand/forearm transplant patients. This protocol combines lymphocyte depletion with donor bone marrow cell infusion and has enabled graft survival using low doses of a single immunosuppressive drug followed by weaning of treatment. Initially designed for living-related solid organ donation, this regimen has been adapted for use with grafts donated by deceased donors. The investigators propose to perform 30 human hand transplants employing this novel protocol. Specific Aims: 1) To establish hand transplantation as a safe and effective reconstructive strategy for the treatment of upper extremity amputations; 2) To reduce the risk of rejection and enable allograft survival while minimizing the requirement for long-term high dose multi-drug immunosuppression. Significance of Research: Hand transplantation could help upper extremity amputees recover functionality, self-esteem, and the capability to reintegrate into family and social life as "whole" individuals. The protocol offers the potential for minimizing the morbidity of maintenance immunosuppression, thereby beneficially shifting the risk/benefit ratio of this life-enhancing procedure and enabling widespread clinical application of hand transplantation.

Eligibility

Min Age: 18 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This study offers hand and arm transplantation (upper extremity allotransplantation) to adults who have lost one or both arms below the shoulder, or who have a non-functional hand. This is a rare surgical procedure that requires lifelong immunosuppressive medication to prevent rejection. You may be eligible if: - You are 18 to 69 years of age - You have had upper limb loss (below the shoulder) or a non-functional hand for at least 6 months - You have no serious co-existing medical or psychological conditions - You have been cancer-free for the past 5 years - You test negative for HIV - You are willing to undergo bone marrow infusion as part of treatment - If female and of childbearing age, you agree to use reliable contraception for at least one year post-transplant You may NOT be eligible if: - You have Type 1 (insulin-dependent) diabetes mellitus - You have high levels of HLA antibodies (sensitized recipient) - You have a bleeding disorder, connective tissue disease, or a condition that could impair wound healing or nerve regeneration - You have active HIV, hepatitis B or C, tuberculosis, or untreated sepsis - You have psychosocial problems such as alcoholism or drug abuse - A psychiatrist deems you unsuitable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREDeceased donor hand transplantation

Deceased donor hand is surgically attached to recipient arm's stump.

DRUGBone marrow cell-based therapy & single-drug immunosuppression.

This protocol uses a novel bone marrow cell-based therapy for composite tissue allotransplantation (CTA) rather than conventional triple-drug immunosuppression to facilitate long-term graft survival of deceased donor human upper extremities under low-dose maintenance immunosuppression. Initial T-cell depletion with alemtuzumab is followed by upper extremity transplantation and tacrolimus maintenance therapy. Donor bone marrow cells are infused on Day 10 (±4 days) post-transplantation to elicit a host alloimmune response triggering exhaustion and deletion of the respective host (anti-donor) lymphocyte clones. Subsequently, tacrolimus therapy is given for at least 6 months before spaced weaning is considered in stable recipients.

Locations(1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT01459107

Related Trials

High-Energy Laser in the Conservative Treatment of Rhizarthrosis

NCT075665071 location

Video-Based Physiotherapy Education and Social Participation in Adults With Hand Injuries

NCT075626201 location