Upper-extremity transplantation using a cell-based protocol to minimize immunosuppression.
Stefan Schneeberger, Vijay S Gorantla, Gerald Brandacher...
https://pubmed.ncbi.nlm.nih.gov/23001085Actively Recruiting
Phase 2
Age: 18Years - 69Years
All Genders
ID01459107
Human Upper Extremity Allotransplantation Using Novel Bone Marrow Cell-Based Therapy and Minimal Immunosuppression
Led by Johns Hopkins University · Updated on 2026-05-12
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Millions of people experience upper limb loss due to injuries, surgeries, or birth defects, and traditional prostheses often provide limited motor function and no sensation. Researchers are evaluating a new immunomodulatory protocol, called the Pittsburgh Protocol, in a Phase II clinical trial to make hand transplantation safer and more effective by reducing the need for lifelong high-dose immunosuppression, which can cause serious side effects like infections and cancer. This study aims to improve the quality of life for individuals with upper extremity amputations by enabling better graft survival with fewer risks. The trial involves performing up to 30 hand or forearm transplants using a novel approach that combines lymphocyte depletion, donor bone marrow cell infusion, and low-dose single-drug immunosuppression (tacrolimus). After transplantation, donor bone marrow cells are infused about 10 days later to help the recipient's immune system accept the graft. Tacrolimus is given for at least six months and then gradually reduced if the transplant remains stable. This protocol was adapted from treatments originally designed for organ donation and aims to minimize the side effects of traditional multi-drug immunosuppression. Participants will undergo thorough screening and follow-up evaluations over up to five years, during which researchers will monitor graft survival and the level of immunosuppressive drugs required to maintain it. Assessments include medical exams, blood tests, and continuous observation of immune response and transplant function. The study also tracks safety outcomes and functional results to better understand how well this protocol supports long-term hand transplant success and patient well-being.
CONDITIONS
Brief Title
Human Upper Extremity Allotransplantation
Who Can Participate
Age: 18Years - 69Years
All Genders
Eligibility Criteria
You may qualify if you...
- Recent (6 months or less) or long-term unilateral or bilateral upper limb loss below the shoulder wanting transplantation
- Amputation is below the shoulder
- Functionless or minimally functional hand suitable for removal and transplantation
- Male or female of any race, color, or ethnicity
- Aged 18 to 69 years
- Completes informed consent form for the study
- No medical condition that affects treatment, surgery, or function as judged by the study team
- No psycho-social problems like alcoholism or drug abuse
- No cancer in the past 5 years
- Negative HIV test at transplant
- Negative donor crossmatch
- If female of child-bearing potential, negative pregnancy test and agrees to use reliable contraception for at least 1 year after transplant
- Consents to bone marrow infusion as part of treatment
- U.S. citizen or equivalent, or foreigner able to pay for transplant and follow-up
- Agrees to comply with treatment protocol and immunomodulatory regimen
You will not qualify if you...
- Untreated sepsis or active infections including HIV, tuberculosis, hepatitis B or C, viral encephalitis, toxoplasmosis
- Cancer within past 5 years
- Current or recent intravenous drug abuse (within 3 months)
- Paralysis of ischemic or traumatic origin
- Inherited or acquired neuropathies including infectious or toxic neuropathy
- Mixed connective tissue disease or collagen diseases affecting wound healing
- Severe deforming rheumatoid or osteoarthritis in the limb
- Recipient conditions like type I diabetes, high panel reactive HLA antibodies, coagulopathies, or other diseases impacting surgery or immunosuppression
- Psychiatrically unsuitable as determined by evaluation
- Donor tattoos that are non-professional within last 6 months or personally identifiable
- Donor must meet brain death criteria, be stable, matched for limb size, blood type, gender, skin tone, and race as appropriate
AI-Screening
AI-Powered Screening
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of transplantation plus initial recovery period
Participants undergo deceased donor hand transplantation where the donor hand is surgically attached to the recipient's arm stump, followed by immediate post-operative care.
1 surgical visit and several immediate post-operative visits
Treatment
Duration - At least 6 months
Participants receive bone marrow cell-based therapy with initial T-cell depletion followed by single-drug immunosuppression with tacrolimus for at least 6 months, including donor bone marrow infusion about 10 days post-transplantation.
Multiple visits including infusion on Day 10 (±4 days) post-transplant and regular follow-ups during immunosuppression
Follow-up
Duration - Up to 5 years after transplantation
Participants are monitored long-term for graft survival and immunosuppression requirements, with potential tacrolimus weaning in stable recipients.
Regular follow-up visits over several years
Trial Site Locations
Total: 1 location
1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
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Research Team
J
Jane Littleton, CRNP, MSN
T
TBD TBD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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