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Human Upper Extremity Allotransplantation

This study is testing a new way to perform hand and arm transplants for people who have lost a limb due to injury. Instead of the usual three anti-rejection medications, this study uses a bone marrow cell-based therapy combined with a single anti-rejection drug. The goal is to help the transplanted hand or arm survive long-term with fewer side effects from medication. You may be able to join if you are between 18 and 69 years old and have lost an upper limb (below the shoulder), whether recently or many years ago. The main goal is to see how long the transplanted limb survives, which will be tracked for up to five years. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 30 participants. It is testing a new procedure for hand transplantation combined with a bone marrow cell-based therapy and single-drug immunosuppression.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure graft survival from the time of transplantation through the end of the study period, which can be up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01459107

Human Upper Extremity Allotransplantation

Recruiting
PHASE2Ages 18–69InterventionalTreatment
Johns Hopkins University
~30 participants
Updated 2026-05-12 on ClinicalTrials.gov
What's tested:Deceased donor hand transplantationBone marrow cell-based therapy & single-drug immunosuppression.

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Graft Survival
Measured over Transplantation through end of study period (up to 5 years)

Conditions

Amputation, Traumatic
Wounds and Injuries
Hand Injuries

Explore related trials

AmputationHand Injury

NCT01459107

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Johns Hopkins University School of Medicine

    Baltimore, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Damon Cooney, MD, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Jane Littleton, CRNP, MSN
[email protected]
410-955-6875
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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.
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

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

What this trial measures

  • Graft SurvivalTransplantation through end of study period (up to 5 years)

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