Vascularized Composite Allotransplantation of the Hand (HandCTA)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00711373 |
|
Recruitment Status :
Recruiting
First Posted : July 8, 2008
Last Update Posted : January 25, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Upper Extremity Injuries | Procedure: Allogeneic hand transplantation | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Vascularized Composite Allotransplantation of the Hand |
| Study Start Date : | June 1998 |
| Estimated Primary Completion Date : | June 2019 |
| Estimated Study Completion Date : | June 2019 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Unilateral and Bilateral Amputees |
Procedure: Allogeneic hand transplantation
Surgical reconstruction of part or all of the hands and/or hands and forearm using tissue from a non-living donor |
- 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.
- 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 ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00711373
| Contact: Tuna Ozyurekoglu, MD | 502-561-0352 | tozyurekoglu@cmki.org | |
| Contact: Donna Stacy, RN | 502-562-0313 | dstacy@cmki.org |
| United States, Kentucky | |
| Kleinert Kutz and Associates/Jewish Hospital and St. Mary's Healthcare | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: Donna Stacy, RN 502-562-0313 dstacy@cmki.org | |
| Contact: Christina L Kaufman, PhD 502-562-0390 ckaufman@cmki.org | |
| Principal Investigator: Chris Jones, MD | |
| Principal Investigator: Tuna Ozyurekoglu, MD | |
| Principal Investigator: | Chris Jones, MD | Jewish Hospital Transplant Center | |
| Principal Investigator: | Tuna Ozyurekoglu, MD | Christine M. Kleinert Institute |
Additional Information:
| Responsible Party: | Christina L. Kaufman PhD, Exec. Director, Christine M. Kleinert Institute for Hand and Microsurgery |
| ClinicalTrials.gov Identifier: | NCT00711373 History of Changes |
| Other Study ID Numbers: |
192.98 DoD-OAR A-14022.5 |
| First Posted: | July 8, 2008 Key Record Dates |
| Last Update Posted: | January 25, 2018 |
| Last Verified: | January 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Christina L. Kaufman PhD, Christine M. Kleinert Institute for Hand and Microsurgery:
|
VCA composite tissue allotransplantation amputation Hand |
Additional relevant MeSH terms:
|
Arm Injuries Wounds and Injuries |