Trial record 3 of 71 for:
Open Studies | "Arm Injuries"
Allogeneic Hand Transplantation Composite Tissue Allotransplantation (HandCTA)
This study is currently recruiting participants.
Verified January 2013 by Christine M. Kleinert Institute for Hand and Microsurgery
Sponsor:
Christina L. Kaufman PhD
Collaborators:
Jewish Hospital and St. Mary's Healthcare
Kleinert, Kutz and Associates
University of Louisville
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Christina L. Kaufman PhD, Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier:
NCT00711373
First received: July 7, 2008
Last updated: January 30, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Upper Extremity Injuries Amputation |
Procedure: Allogeneic hand transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Composite Tissue Allotransplantation of the Hand |
Resource links provided by NLM:
Further study details as provided by Christine M. Kleinert Institute for Hand and Microsurgery:
Primary Outcome Measures:
- functioning allograft [ Time Frame: Monthly functional analysis for first three months and then on an annual basis for the life of the graft ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 10 |
| Study Start Date: | June 1998 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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
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 more than 12 years post transplant. We have also transplanted five 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711373
Contacts
| Contact: Joseph E Kutz, MD | 502-561-4244 | jkutz@cmki.org |
| Contact: Brenda Blair, RN | 502-562-0313 | bblair@cmki.org |
Locations
| United States, Kentucky | |
| Kleinert Kutz and Associates/Jewish Hospital and St. Mary's Healthcare | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: Brenda Blair, RN 502-562-0313 bblair@cmki.org | |
| Contact: Christina L Kaufman, PhD 502-562-0390 ckaufman@cmki.org | |
| Principal Investigator: Michael Marvin, MD | |
| Principal Investigator: Joseph E Kutz, MD | |
Sponsors and Collaborators
Christina L. Kaufman PhD
Jewish Hospital and St. Mary's Healthcare
Kleinert, Kutz and Associates
University of Louisville
U.S. Army Medical Research and Materiel Command
Investigators
| Principal Investigator: | Michael Marvin, MD | Jewish Hospital Transplant Center |
| Principal Investigator: | Joseph E Kutz, MD | Christine M. Kleinert Institute |
More Information
Additional Information:
No publications provided
| 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 |
| Study First Received: | July 7, 2008 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Christine M. Kleinert Institute for Hand and Microsurgery:
|
CTA composite tissue allotransplantation amputation Hand |
Additional relevant MeSH terms:
|
Arm Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013