AmputationVCA-01NCT00778856
Hand Transplantation for the Reconstruction of Below the Elbow Amputations
A study testing Hand transplantation in people with Amputation and Transplantation, run by Emory University at 2 sites in United States.
Trial summary
Organ transplantation has become the treatment of choice for most patients suffering end stage diseases of the kidney, pancreas, liver, heart or lung. Vascularized Composite Allotransplantation (VCA) {a.k.a. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Amputation, Transplantation
- What is being tested?
- Hand transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2008to Mar 2013
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- male or female, 18-55 years of age, with below elbow amputation
- ability to give informed consent
Who cannot join
- Any condition that precludes serial follow-up.
- Any active malignancy or any history of a hematogenous malignancy or lymphoma. Patients with primary, cutaneous basal cell or squamous cell cancers may be enrolled providing these are appropriately eliminated prior to transplant. For amputations due to malignancy, 5 years recurrence free survival will be required prior to enrollment.
- Any known immunodeficiency syndrome.
- Inability or unwillingness to comply with protocol monitoring and therapy, including, among others, a history of noncompliance, circumstances where compliance with protocol requirements is not feasible due to living conditions, travel restrictions, access to urgent medical services
- Pregnancy or unwillingness to practice birth control methods during the first year of the study.
- Unwillingness to undergo blood transfusion if clinically indicated
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Veterans Affairs Medical Center
Atlanta, Georgia, 30033
Emory University
Atlanta, Georgia, 30322
About this study
Organ transplantation has become the treatment of choice for most patients suffering end stage diseases of the kidney, pancreas, liver, heart or lung.
Vascularized Composite Allotransplantation (VCA) {a.k.a. composite tissue allotransplantation} is the term used to describe transplantation of multiple tissues (skin, muscle, bone, cartilage, nerve, tendon, vessel) as a functional unit (e.g. hand). Several recent advances in clinical organ transplant immunosuppression and experimental limb VCA have now made it feasible to consider clinical VCA for the functional restoration of patients with loss of one or both hands.
Read more
This protocol facilitates the development of limb VCA at the Atlanta Veterans Affairs Medical Center (VAMC) and at Emory University for patients with below the elbow amputations. It will evaluate the patients' use of transplanted limb(s) in activities of daily living and compare the function of the transplanted hand to the function with their previous prosthesis.
Patients with below the elbow amputations will be enrolled. Donor tissue will be recovered from deceased donors following the guidelines of and in cooperation with the regional Organ Procurement Organization. The transplantation procedure and postoperative care will be performed using the standard technique for limb replantation. Patients will receive standard immunosuppressive regimen. Rejections will be treated in keeping with experience from the solid organ transplant experience. Graft failure will be treated with allograft amputation.
Read the detailed description
This protocol will study patients with below the elbow amputations who are selected to undergo limb allotransplantation. We will study patients after they have been trained on the use of a prosthetic limb device prior to transplantation. We will treat them with immunosuppression known to prevent the rejection of other allografted tissues and designed to minimize their dependence on chronic maintenance immunosuppression. These patients will be studied to determine whether the transplanted limb functions better, worse or the same as a prosthetic hand, and to quantify those differences
- Conditions
- Amputation, Transplantation
- Being tested
- Hand transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand transplantationProcedure or surgery
allotransplantation of deceased donor composite tissue (hand and forearm)
| Study group | Role | What they receive |
|---|---|---|
| Hand Transplant | Experimental | Not described Receives: Procedure: Hand transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability-relative to prosthetic limbs-to use the transplanted limb in activities of daily living, measured by quantitative functional tests
Measured: 18 months
Secondary outcomes (2)
Incidence of hand allograft rejection
Measured: 2 years
Development/presence of alloantibodies
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Principal Investigator relocated to another institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda C Cendales, MD, Emory University
- Investigators
- Linda C. Cendales, MD, Principal investigator, Emory University School of Medicine, VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778856
- Sponsor's protocol ID
- IRB00007760
- Acronym
- VCA-01
- Status last verified
- Mar 2015
- First submitted
- 7 Oct 2008
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Transplantation for the Reconstruction of Below the Elbow Amputations
- ClinicalTrials.gov ID
- NCT00778856
- Acronym / sponsor ID
- VCA-01 / IRB00007760
- Conditions
- Amputation, Transplantation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator relocated to another institution
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 24 Oct 2008 (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.
Organ transplantation has become the treatment of choice for most patients suffering end stage diseases of the kidney, pancreas, liver, heart or lung.
Vascularized Composite Allotransplantation (VCA) {a.k.a. composite tissue allotransplantation} is the term used to describe transplantation of multiple tissues (skin, muscle, bone, cartilage, nerve, tendon, vessel) as a functional unit (e.g. hand). Several recent advances in clinical organ transplant immunosuppression and experimental limb VCA have now made it feasible to consider clinical VCA for the functional restoration of patients with loss of one or both hands.
This protocol facilitates the development of limb VCA at the Atlanta Veterans Affairs Medical Center (VAMC) and at Emory University for patients with below the elbow amputations. It will evaluate the patients' use of transplanted limb(s) in activities of daily living and compare the function of the transplanted hand to the function with their previous prosthesis.
Patients with below the elbow amputations will be enrolled. Donor tissue will be recovered from deceased donors following the guidelines of and in cooperation with the regional Organ Procurement Organization. The transplantation procedure and postoperative care will be performed using the standard technique for limb replantation. Patients will receive standard immunosuppressive regimen. Rejections will be treated in keeping with experience from the solid organ transplant experience. Graft failure will be treated with allograft amputation.
Detailed description
This protocol will study patients with below the elbow amputations who are selected to undergo limb allotransplantation. We will study patients after they have been trained on the use of a prosthetic limb device prior to transplantation. We will treat them with immunosuppression known to prevent the rejection of other allografted tissues and designed to minimize their dependence on chronic maintenance immunosuppression. These patients will be studied to determine whether the transplanted limb functions better, worse or the same as a prosthetic hand, and to quantify those differences
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hand Transplant | Experimental | Procedure: Hand transplantation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- male or female, 18-55 years of age, with below elbow amputation
- ability to give informed consent
Key exclusion criteria (6 listed)
- Any condition that precludes serial follow-up.
- Any active malignancy or any history of a hematogenous malignancy or lymphoma. Patients with primary, cutaneous basal cell or squamous cell cancers may be enrolled providing these are appropriately eliminated prior to transplant. For amputations due to malignancy, 5 years recurrence free survival will be required prior to enrollment.
- Any known immunodeficiency syndrome.
- Inability or unwillingness to comply with protocol monitoring and therapy, including, among others, a history of noncompliance, circumstances where compliance with protocol requirements is not feasible due to living conditions, travel restrictions, access to urgent medical services
- Pregnancy or unwillingness to practice birth control methods during the first year of the study.
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 |
|---|---|---|
| Hand transplantationallotransplantation of deceased donor composite tissue (hand and forearm) | Procedure or surgery | Hand Transplant |
Primary outcome
Ability-relative to prosthetic limbs-to use the transplanted limb in activities of daily living, measured by quantitative functional tests
Time frame: 18 months
2 secondary outcomes
Incidence of hand allograft rejection
Time frame: 2 years
Development/presence of alloantibodies
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Principal Investigator relocated to another institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
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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.
Linda C. Cendales, MD principal investigator
Emory University School of Medicine, VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand transplantation in people with Amputation and Transplantation, run by Emory University at 2 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early (reason given: Principal Investigator relocated to another institution). Results are not available in the source record.
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?
Ability-relative to prosthetic limbs-to use the transplanted limb in activities of daily living, measured by quantitative functional tests (time frame: 18 months). 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 27 Mar 2015.