Transplanting hands to restore function and appearance

Human Upper Extremity Allotransplantation

This study is testing a new way to do hand transplants for people who have lost their hands to see if it can help them regain function and improve their quality of life.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 69 Years
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT01459107 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial focuses on hand transplantation for individuals who have experienced upper limb loss due to trauma, amputation, or congenital defects. The study aims to evaluate a new immunomodulatory protocol that utilizes deceased donor hand transplantation combined with bone marrow cell-based therapy and single-drug immunosuppression. By documenting the outcomes of this approach, the trial seeks to improve the safety and effectiveness of hand transplants, which have been limited by the risks associated with traditional immunosuppressive therapies. Participants will be closely monitored to assess functional recovery and quality of life improvements following the procedure.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-69 who have experienced recent or remote upper limb loss and desire hand transplantation.

Not a fit: Patients with co-existing medical or psycho-social conditions that could complicate the surgical procedure or immunomodulatory protocol may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly enhance the quality of life for patients by restoring the functionality and appearance of their hands.

How similar studies have performed: Previous hand transplantation studies have shown promising functional results, but this specific approach with a new immunomodulatory protocol is relatively novel.

Eligibility criteria

Recipient Inclusion Criteria:

* Recent (≥6 months) or remote (i.e., several decades) unilateral or bilateral upper limb loss (below the shoulder) desiring limb transplantation.
* Below-shoulder amputation.
* Functionless or minimally functional hand desiring removal of functionless / minimally functional hand followed by transplantation.
* Male or female and of any race, color or ethnicity.
* Aged 18-69 years.
* Completes the protocol informed consent form.
* No co-existing medical condition which, in the opinion of the study team, could affect the immunomodulatory protocol, surgical procedure, or functional results (see Donor and Recipient Exclusion Criteria below. If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of upper extremity transplantation.)
* No co-existing psycho-social problems (i.e., alcoholism, drug abuse).
* Negative for malignancy for past 5 years.
* Negative for HIV at transplant.
* Negative crossmatch with donor.
* If female of child-bearing potential, negative serum pregnancy test.
* If female of child-bearing potential, consent to use reliable contraception for at least one year following transplantation.
* Consents to bone marrow infusion as part of the treatment regime.
* USA citizen or equivalent, or foreigner with documentation of ability to pay for transplant and required follow-up care.
* Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime.

Donor Inclusion Criteria:

Donors will be selected by the upper extremity transplant team in conjunction with the organ procurement organization (OPO) according to the following criteria:

* Brain dead meeting the criteria for Determination of Death.
* Family consent for limb donation.
* Stable donor (i.e., does not require excessive vasopressors to maintain blood pressure).
* Aged 16 - 65 years.
* Limb matched for size with recipient.
* Same blood type as recipient.
* Negative lymphocytotoxic crossmatch.
* Accurately matched for gender, skin tone, and race (relative requirements depending on recipient consent).

Exclusion Criteria:

• Positive for any of the following conditions:

* Untreated sepsis.
* HIV (active or seropositive).
* Active tuberculosis.
* Hepatitis B or C.
* Viral encephalitis.
* Toxoplasmosis.
* Malignancy (within past 5 years).
* Current/recent (within 3 months of donation/screening consent) IV drug abuse.
* Paralysis of ischemic or traumatic origin.
* Inherited peripheral neuropathy.
* Infectious, post infectious, or inflammatory (axonal or demyelinating) neuropathy.
* Toxic neuropathy (i.e. heavy metal poisoning, drug toxicity, industrial agent exposure).
* Mixed connective tissue disease.
* Severe deforming rheumatoid or osteoarthritis in the limb.

Donor Only:

• Tattoos:

* Non-professional tattoo within last 6 months, or
* Personally identifiable tattoo (i.e., donor name) on potential transplant.

Recipient Only:

* Type I (insulin-dependent) diabetes mellitus
* Conditions that, in the opinion of the study team, may impact the immunomodulatory protocol potentially exposing the recipient to an unacceptable risk under immunosuppressive treatment.
* Sensitized recipients with high levels (50%) of panel-reactive human leukocyte antigen (HLA) antibodies.
* Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias, Sickle Cell disease, etc.
* Mixed connective tissue diseases and collagen diseases can result in poor wound healing after surgery.
* Conditions that may impact functional outcomes including Lipopolysaccharidosis and amyloidosis (may impact nerve regeneration) or rare disorders of bone healing like osteopetrosis.
* Patients considered unsuitable per the consulted Psychiatrists appraisal.

Where this trial is running

Baltimore, Maryland

• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Damon Cooney, MD, PhD — Johns Hopkins University
• Study coordinator: Jane Littleton, CRNP, MSN

Conditions Amputation, Traumatic; Wounds and Injuries; Hand Injuries; Hand Transplant; Composite Tissue Allotransplantation; Vascularized Composite Allotransplantation; Composite Tissue; Amputation