Upper Extremity InjuriesPhase 2HandCTANCT00711373
Vascularized Composite Allotransplantation of the Hand
A Phase 2 study testing Allogeneic hand transplantation in people with Upper Extremity Injuries, run by Christina L. Kaufman PhD at 1 site in United States.
Trial summary
This is a clinical trial of unilateral and bilateral hand transplantation. This will be done by the surgical transfer of a hand from a non-living donor to restore function of non-functioning or amputated hand. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Upper Extremity Injuries
- What is being tested?
- Allogeneic hand transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1998to Jun 2019
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates may be male or female patients between the ages of 18 and 65 who are missing all or part of a hand and forearm
- No serious co-existing medical or psycho-social problems
- Must be HIV negative at the time of transplant
- Crossmatch is negative between donor and recipient
- Women who are of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours of transplant and agree to use reliable contraception for one year following transplant
- Subjects must give written informed consent
Who cannot join
- Uncontrolled infection or severe concomitant diseases which would exclude the recipient from transplantation
- Alcoholism not currently under control
- Malignancy
- Excessive proximal level of amputation: some presence of proximal muscles is required to motor a functioning hand
- Congenital Abnormalities: co-existent absence/atrophy/agenesis of any tissue may affect post transplant results
- History of amputation of less than six months: subject must be allowed to attempt prosthetic use prior to hand transplantation
- Blindness: blind amputees may be poor candidates because sensory return in the hand may not provide sufficient protective sensation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kleinert Kutz and Associates/Jewish Hospital and St. Mary's Healthcare
Louisville, Kentucky, 40202
Donna Stacy, RN, 502-562-0313, dstacy@cmki.org
Christina L Kaufman, PhD, 502-562-0390, ckaufman@cmki.org
About this study
This is a clinical trial of unilateral and bilateral hand transplantation. This will be done by the surgical transfer of a hand from a non-living donor to restore function of non-functioning or amputated hand. Recipients must currently take the same type of drugs as a kidney transplant patient to prevent rejection of the hand.
Read the detailed description
At the Christine M. Kleinert Institute in Louisville, Kentucky, we are recruiting patients for a research protocol that is underway for Composite Tissue Allotransplantation of the Hand. This study is not for all upper extremity injuries, but it is a possibility for some.
The Hand Surgeons at Kleinert, Kutz and Associates and the Christine M. Kleinert Institute performed the first hand transplant in the United States. This patient is doing very well, and is now almost 15 years post transplant. We have also transplanted seven other recipients, including a bilateral recipient. For more information visit www.handtransplant.com.
While hand transplantation is a viable option for select upper extremity amputees, there are significant risks that must be understood before a patient can decide whether hand transplantation is the right option for him or her. The major risk is the systemic immunosuppression that all current hand transplant recipients must take.
As part of this clinical trial of hand transplanation we are also offering a sub-study sub study to determine if cells isolated from fat tissue can be used to control the immune response against the graft. This population of cells that will be isolated from fat tissue is called the stromal vascular fraction (SVF) and has been used on an experimental basis in patients who have problems with blood vessels in their legs, with patients who have received a bone marrow transplant, and with patients who have Chron's disease. These trials have also been experimental. To date, there have been no cases where the SVF cells isolated from and used in the same patient have been associated with harmful side effects.
In this optional sub-study SVF isolated from the patient's own fat tissue would be injected into the graft at the time of transplant, or at the time of a rejection episode. We hope that these cells will help the hand and the nerves heal, and help control your immune systems response against the donor hand. However, this is an experimental study and we don't know if this will work or not. After your transplant and the injection of the SVF cells you will be followed and treated the same as any other hand transplant recipient in this clinical trial.
This sub-study is optional. Subjects can choose to not participate in this sub-study and still be able to participate in the hand transplant clinical trial.
- Conditions
- Upper Extremity Injuries
- Being tested
- Allogeneic hand transplantation
- Keywords
- VCA, composite tissue allotransplantation, amputation, Hand
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic hand transplantationProcedure or surgery
Surgical reconstruction of part or all of the hands and/or hands and forearm using tissue from a non-living donor
| Study group | Role | What they receive |
|---|---|---|
| Unilateral and Bilateral Amputees | Experimental | Not described Receives: Procedure: Allogeneic hand transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
functioning allograft
Subjects will be monitored in Louisville for three months. After that subject will be monitored for function of the allograft on an annual basis or as clinical course indicates. We are requesting that subjects allow function to be evaluated on an annual basis for the life of the graft.
Measured: Monthly functional analysis for first three months and then on an annual basis for the life of the graft
Secondary outcomes (1)
document and manage complications associated with Composite Tissue allotransplantation
Transplant recipients will have drug levels drawn weekly and then monthly until target blood levels of immunosuppression are acheived. We will then have blood drawn monthly and then quarterly as time progresses. We are requesting that subjects allow us to follow them for the life of the graft.
Measured: monthly labs for the first year, then bi-monthly for the first five years, or as clincial course indicates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2008 (estimated)
- Study startJun 1998
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity InjuriesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christina L. Kaufman PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Jewish Hospital and St. Mary's Healthcare, Kleinert, Kutz and Associates, University of Louisville, U.S. Army Medical Research and Development Command, United States Department of Defense
- Responsible party
- Sponsor-investigator, Christina L. Kaufman PhD, Christine M. Kleinert Institute for Hand and Microsurgery
- Investigators
- Chris Jones, MD, Principal investigator, Jewish Hospital Transplant CenterTuna Ozyurekoglu, MD, Principal investigator, Christine M. Kleinert Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711373
- Sponsor's protocol ID
- 192.98
- Other IDs
- DoD-OAR A-14022.5
- Acronym
- HandCTA
- Status last verified
- Jan 2018
- First submitted
- 7 Jul 2008
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascularized Composite Allotransplantation of the Hand
- ClinicalTrials.gov ID
- NCT00711373
- Acronym / sponsor ID
- HandCTA / 192.98
- Conditions
- Upper Extremity Injuries
- Keywords
- VCA, composite tissue allotransplantation, amputation, Hand
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Christina L. Kaufman PhDUniversity, hospital or other
- Collaborators
- Jewish Hospital and St. Mary's Healthcare, Kleinert, Kutz and Associates, University of Louisville, U.S. Army Medical Research and Development Command, United States Department of Defense
- Study start
- Jun 1998
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 8 Jul 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.
This is a clinical trial of unilateral and bilateral hand transplantation. This will be done by the surgical transfer of a hand from a non-living donor to restore function of non-functioning or amputated hand. Recipients must currently take the same type of drugs as a kidney transplant patient to prevent rejection of the hand.
Detailed description
At the Christine M. Kleinert Institute in Louisville, Kentucky, we are recruiting patients for a research protocol that is underway for Composite Tissue Allotransplantation of the Hand. This study is not for all upper extremity injuries, but it is a possibility for some.
The Hand Surgeons at Kleinert, Kutz and Associates and the Christine M. Kleinert Institute performed the first hand transplant in the United States. This patient is doing very well, and is now almost 15 years post transplant. We have also transplanted seven other recipients, including a bilateral recipient. For more information visit www.handtransplant.com.
While hand transplantation is a viable option for select upper extremity amputees, there are significant risks that must be understood before a patient can decide whether hand transplantation is the right option for him or her. The major risk is the systemic immunosuppression that all current hand transplant recipients must take.
As part of this clinical trial of hand transplanation we are also offering a sub-study sub study to determine if cells isolated from fat tissue can be used to control the immune response against the graft. This population of cells that will be isolated from fat tissue is called the stromal vascular fraction (SVF) and has been used on an experimental basis in patients who have problems with blood vessels in their legs, with patients who have received a bone marrow transplant, and with patients who have Chron's disease. These trials have also been experimental. To date, there have been no cases where the SVF cells isolated from and used in the same patient have been associated with harmful side effects.
In this optional sub-study SVF isolated from the patient's own fat tissue would be injected into the graft at the time of transplant, or at the time of a rejection episode. We hope that these cells will help the hand and the nerves heal, and help control your immune systems response against the donor hand. However, this is an experimental study and we don't know if this will work or not. After your transplant and the injection of the SVF cells you will be followed and treated the same as any other hand transplant recipient in this clinical trial.
This sub-study is optional. Subjects can choose to not participate in this sub-study and still be able to participate in the hand transplant clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unilateral and Bilateral Amputees | Experimental | Procedure: Allogeneic hand transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Candidates may be male or female patients between the ages of 18 and 65 who are missing all or part of a hand and forearm
- No serious co-existing medical or psycho-social problems
- Must be HIV negative at the time of transplant
- Crossmatch is negative between donor and recipient
- Women who are of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours of transplant and agree to use reliable contraception for one year following transplant
Key exclusion criteria (8 listed)
- Uncontrolled infection or severe concomitant diseases which would exclude the recipient from transplantation
- Alcoholism not currently under control
- Malignancy
- Excessive proximal level of amputation: some presence of proximal muscles is required to motor a functioning hand
- Congenital Abnormalities: co-existent absence/atrophy/agenesis of any tissue may affect post transplant results
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 |
|---|---|---|
| Allogeneic hand transplantationSurgical reconstruction of part or all of the hands and/or hands and forearm using tissue from a non-living donor | Procedure or surgery | Unilateral and Bilateral Amputees |
Primary outcome
functioning allograft
Time frame: Monthly functional analysis for first three months and then on an annual basis for the life of the graft
Subjects will be monitored in Louisville for three months. After that subject will be monitored for function of the allograft on an annual basis or as clinical course indicates. We are requesting that subjects allow function to be evaluated on an annual basis for the life of the graft.
1 secondary outcome
document and manage complications associated with Composite Tissue allotransplantation
Time frame: monthly labs for the first year, then bi-monthly for the first five years, or as clincial course indicates
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Please visit the above website for more study information.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Chris Jones, MD principal investigator
Jewish Hospital Transplant Center
Tuna Ozyurekoglu, MD principal investigator
Christine M. Kleinert Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allogeneic hand transplantation in people with Upper Extremity Injuries, run by Christina L. Kaufman PhD at 1 site 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuna Ozyurekoglu, MD (502-561-0352, tozyurekoglu@cmki.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functioning allograft (time frame: Monthly functional analysis for first three months and then on an annual basis for the life of the graft). 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 25 Jan 2018.