Human Upper Extremity Allotransplantation

Launched by JOHNS HOPKINS UNIVERSITY · Oct 24, 2011

Keywords

ClinConnect Summary

This clinical trial is studying a new way to perform hand and arm transplants for people who have lost limbs due to injury, illness, or congenital defects. The goal is to make these transplants safer and more effective by using a special treatment plan that reduces the need for strong medications that prevent the body from rejecting the new limb. This is important because while hand transplants can significantly improve a person's function and quality of life, the current medications can lead to serious side effects. The researchers aim to perform 30 hand transplants using this innovative approach, which combines techniques that allow for lower doses of medication.

To be eligible for this trial, participants should be adults aged 18 to 69 who have lost one or both arms below the shoulder and want to undergo a transplant. They should not have any major health issues that could interfere with the surgery or recovery. Participants can expect to undergo surgery to receive a new hand or arm, and they will follow a specific treatment plan to help ensure the success of the transplant while minimizing the need for long-term medication. This trial offers a promising opportunity for those looking to regain function and improve their overall quality of life after an amputation.

Gender

ALL

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.