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Human Upper Extremity Allotransplantation

Phase 2
18 Years
69 Years
Open (Enrolling)
Amputation, Traumatic, Wounds and Injuries, Hand Injuries

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Trial Information

Human Upper Extremity Allotransplantation

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.

- 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.

- Patient agrees to comply with the protocol and states a dedication to the
immunomodulatory treatment regime.

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)

- Toxic neuropathy (i.e. heavy metal poisoning, drug toxicity, industrial agent

- Mixed connective tissue disease.

- Severe deforming rheumatoid or osteoarthritis in the limb.

- 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 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

- Patients considered unsuitable per the consulted Psychiatrists appraisal.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Graft Survival

Outcome Description:

Post-operative graft survival will be documented monthly Months 1-12 and quarterly (every 3 months) Years 2-5.

Outcome Time Frame:

Transplantation through end of study period (up to 5 years)

Safety Issue:


Principal Investigator

W. P. Andrew Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University


United States: Institutional Review Board

Study ID:




Start Date:

July 2011

Completion Date:

June 2021

Related Keywords:

  • Amputation, Traumatic
  • Wounds and Injuries
  • Hand Injuries
  • Hand Transplant
  • CTA
  • VCA
  • Composite Tissue
  • Amputation
  • Upper limb
  • Immunosuppression
  • Amputation, Traumatic
  • Hand Injuries
  • Wounds and Injuries



Johns Hopkins University School of Medicine Baltimore, Maryland  21205