Status:
RECRUITING
Human Upper Extremity Allotransplantation
Lead Sponsor:
Johns Hopkins University
Conditions:
Amputation, Traumatic
Wounds and Injuries
Eligibility:
All Genders
18-69 years
Phase:
PHASE2
Brief 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, forear...
Eligibility Criteria
Inclusion
- Recipient
- 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
- 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
- • 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.
Key Trial Info
Start Date :
July 21 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2036
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01459107
Start Date
July 21 2011
End Date
June 30 2036
Last Update
May 11 2025
Active Locations (1)
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1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287