Traumatic Amputation of ArmNCT02165865
Vascularized Composite Allotransplantation of the Hand and Upper Extremity (Hand Transplant)
A study testing upper extremity/ hand transplantation in people with Traumatic Amputation of Arm and Traumatic Amputation of Hand, run by Southern Illinois University at 3 sites in United States.
Trial summary
The Southern Illinois University (SIU) Hand Transplant Program is a multidisciplinary research effort with the goal of restoring form and function to unilateral or bilateral upper extremity amputees by vascularized composite allotransplantation of the hand/upper extremity (hand transplantation). Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Traumatic Amputation of Arm, Traumatic Amputation of Hand
- What is being tested?
- upper extremity/ hand transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent (≥6 months) or remote (i.e., several decades) unilateral or bilateral upper limb loss from trauma or other causes desiring limb transplantation
- Below-shoulder amputation
- Male or female and of any race, color or ethnicity
- Aged 18-69 years
- Willing and able to understand and sign informed consent form
- No co-existing medical condition which, in the opinion of the study team, would place them at high risk for the surgical procedure, immunosuppression protocol, or functional results
Show all 14Show fewer
- No co-existing psychosocial problems (i.e., alcoholism, drug abuse, lack of social support) or issue identified during psychosocial battery of testing
- Negative for malignancy for past 5 years
- Negative for hepatitis C virus or 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
- Willing and able to sign consents for tissue studies
- Willing to comply with Intermediate System (IS) and hand therapy protocols
Who cannot join
- Conditions that, in the opinion of the investigators, would place patient at unacceptably high risk for the surgical procedure, immunosuppression protocol, or functional results
- Sensitized recipients with high levels (>70%) 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 that may result in poor wound healing after surgery.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Memorial Medical Center
Springfield, Illinois, 62781
SIU Institute for Plastic Surgery
Springfield, Illinois, 62794-9653
Southern Illinois University School of Medicine
Springfield, Illinois, 62794-9653
About this study
Official title: Vascularized Composite Allotransplantation of the Hand and Upper Extremity for the Restoration of Form and Function in Hand Amputees
The Southern Illinois University (SIU) Hand Transplant Program is a multidisciplinary research effort with the goal of restoring form and function to unilateral or bilateral upper extremity amputees by vascularized composite allotransplantation of the hand/upper extremity (hand transplantation). Hand transplantation includes transferring upper extremities/hands from deceased human donors to patients with single or bilateral hand or arm amputation. The purpose of the trial is to study functional, psychological, and immunological outcomes of human upper extremity allotransplantation.
Read the detailed description
Hand transplantation is the surgical attachment of a hand and sometimes an arm from an organ donor to a person who has previously suffered an amputation. It is similar to other organ transplants, such as a heart, liver, or kidney, in that the tissue comes from a deceased donor and therefore requires lifelong medications to prevent rejection. Hand transplantation also requires extensive hand rehabilitation to regain function of the transplanted limb.
The primary focus of the study is to perform hand transplantation using a steroid-sparing immunosuppression regimen, to closely follow outcomes for at least 2 years after the transplant, and to utilize new methods for immune system and functional recovery. The number and severity of side effects and the treatment provided will be analyzed in relation to the standard immunosuppressive drugs used. Functional and clinical outcomes will be correlated with data on quality of life.
After consultation with the study team and signing of the study consent forms, patients will undergo a thorough screening phase, including imaging, laboratory tests, age-appropriate screening, psychosocial evaluations, physical and occupational therapy (OT) screening, and tissue typing. Patients will then be selected by a formal patient selection committee meeting, based on results of screening procedures.
If found to be a good candidate for hand transplantation, the patient will be listed with the United Network for Organ Sharing (UNOS) to wait for a compatible donor. Organ donors from the surrounding region will be screened for compatibility in regards to blood type and tissue type, as well as hand size, skin color, tone, and hair patterns. Once a matching donor is located, the hand transplant team and participant will be notified.
After surgery the patient will stay in the intensive care unit for 1-3 days and then move to a regular hospital room where they will stay for 1-2 weeks. Physical therapy will begin within 2-3 days after surgery, and transplant staff will give daily information on the anti-rejection medications. After discharge from the hospital, the patient will stay locally for 3-6 months to monitor for signs of rejection and for extensive hand rehabilitation. Housing will be provided during this period by the hospital. Functional, psychological and immunological outcomes will then be closely followed for the life of the allograft.
- Being tested
- upper extremity/ hand transplantation
- Keywords
- hand transplantation, hand allotransplantation, upper extremity transplantation, upper extremity amputation, hand amputation, vascularized composite allotransplantation, composite tissue allotransplantation, variance component analysis (VCA), composite tissue allograft (CTA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper extremity/ hand transplantationProcedure or surgery
hand transplant on unilateral dominant hand or bilateral upper extremity amputees
| Study group | Role | What they receive |
|---|---|---|
| upper extremity/ hand transplantation | Experimental | hand transplant on unilateral dominant hand or bilateral upper extremity amputees Receives: Procedure: upper extremity/ hand transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
hand allograft survival
Measured: Transplantation through end of study period (up to 5 years)
Secondary outcomes (4)
hand allograft function
tests, 2 point discrimination, electromyography (EMG)/nerve conduction studies, range of motion, and a functional status assessment that includes activities of daily living
Measured: Transplantation through end of study period (up to 5 years)
immunological response to hand transplantation
white blood cell counts, immunosuppression serum drug levels, donor specific antigen levels, tissue biopsy Banff grades
Measured: Transplantation through end of study period (up to 5 years)
brain cortical reorganization and adaptation
functional MRI
Measured: Transplantation through end of study period (up to 5 years)
psychosocial impact
Flannagan QOL (quality of life) survey and the Connor-Davidson Resilience Scale (CD-RISC)
Measured: Transplantation through end of study period (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Amputation of ArmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Medical Center Foundation, Memorial Medical Center
- Responsible party
- Sponsor
- Investigators
- Michael W Neumeister, MD, Principal investigator, Southern Illinois University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165865
- Sponsor's protocol ID
- NEU-SIUSOM-13-001
- Status last verified
- Jul 2019
- First submitted
- 24 Jan 2014
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascularized Composite Allotransplantation of the Hand and Upper Extremity for the Restoration of Form and Function in Hand Amputees
- ClinicalTrials.gov ID
- NCT02165865
- Acronym / sponsor ID
- NEU-SIUSOM-13-001
- Keywords
- hand transplantation, hand allotransplantation, upper extremity transplantation, upper extremity amputation, hand amputation, vascularized composite allotransplantation, composite tissue allotransplantation, variance component analysis (VCA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Southern Illinois UniversityUniversity, hospital or other
- Collaborators
- Memorial Medical Center Foundation, Memorial Medical Center
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Southern Illinois University (SIU) Hand Transplant Program is a multidisciplinary research effort with the goal of restoring form and function to unilateral or bilateral upper extremity amputees by vascularized composite allotransplantation of the hand/upper extremity (hand transplantation). Hand transplantation includes transferring upper extremities/hands from deceased human donors to patients with single or bilateral hand or arm amputation. The purpose of the trial is to study functional, psychological, and immunological outcomes of human upper extremity allotransplantation.
Detailed description
Hand transplantation is the surgical attachment of a hand and sometimes an arm from an organ donor to a person who has previously suffered an amputation. It is similar to other organ transplants, such as a heart, liver, or kidney, in that the tissue comes from a deceased donor and therefore requires lifelong medications to prevent rejection. Hand transplantation also requires extensive hand rehabilitation to regain function of the transplanted limb.
The primary focus of the study is to perform hand transplantation using a steroid-sparing immunosuppression regimen, to closely follow outcomes for at least 2 years after the transplant, and to utilize new methods for immune system and functional recovery. The number and severity of side effects and the treatment provided will be analyzed in relation to the standard immunosuppressive drugs used. Functional and clinical outcomes will be correlated with data on quality of life.
After consultation with the study team and signing of the study consent forms, patients will undergo a thorough screening phase, including imaging, laboratory tests, age-appropriate screening, psychosocial evaluations, physical and occupational therapy (OT) screening, and tissue typing. Patients will then be selected by a formal patient selection committee meeting, based on results of screening procedures.
If found to be a good candidate for hand transplantation, the patient will be listed with the United Network for Organ Sharing (UNOS) to wait for a compatible donor. Organ donors from the surrounding region will be screened for compatibility in regards to blood type and tissue type, as well as hand size, skin color, tone, and hair patterns. Once a matching donor is located, the hand transplant team and participant will be notified.
After surgery the patient will stay in the intensive care unit for 1-3 days and then move to a regular hospital room where they will stay for 1-2 weeks. Physical therapy will begin within 2-3 days after surgery, and transplant staff will give daily information on the anti-rejection medications. After discharge from the hospital, the patient will stay locally for 3-6 months to monitor for signs of rejection and for extensive hand rehabilitation. Housing will be provided during this period by the hospital. Functional, psychological and immunological outcomes will then be closely followed for the life of the allograft.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| upper extremity/ hand transplantation | Experimental | Procedure: upper extremity/ hand transplantationhand transplant on unilateral dominant hand or bilateral upper extremity amputees |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Recent (≥6 months) or remote (i.e., several decades) unilateral or bilateral upper limb loss from trauma or other causes desiring limb transplantation
- Below-shoulder amputation
- Male or female and of any race, color or ethnicity
- Aged 18-69 years
- Willing and able to understand and sign informed consent form
Key exclusion criteria (4 listed)
- Conditions that, in the opinion of the investigators, would place patient at unacceptably high risk for the surgical procedure, immunosuppression protocol, or functional results
- Sensitized recipients with high levels (>70%) 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 that may result in poor wound healing after surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| upper extremity/ hand transplantationhand transplant on unilateral dominant hand or bilateral upper extremity amputees | Procedure or surgery | upper extremity/ hand transplantation |
Primary outcome
hand allograft survival
Time frame: Transplantation through end of study period (up to 5 years)
4 secondary outcomes
hand allograft function
Time frame: Transplantation through end of study period (up to 5 years)
immunological response to hand transplantation
Time frame: Transplantation through end of study period (up to 5 years)
brain cortical reorganization and adaptation
Time frame: Transplantation through end of study period (up to 5 years)
psychosocial impact
Time frame: Transplantation through end of study period (up to 5 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Transplant Services at Memorial Medical CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael W Neumeister, MD principal investigator
Southern Illinois University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing upper extremity/ hand transplantation in people with Traumatic Amputation of Arm and Traumatic Amputation of Hand, run by Southern Illinois University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hand allograft survival (time frame: Transplantation through end of study period (up to 5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.