ImmunosuppressionPhase 2NCT02310867
Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy
A Phase 2 study testing Belatacept and Hand transplant in people with Immunosuppression, run by Linda Cendales at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of hand transplantation as a treatment for patients with loss of limb below the elbow, The study will focus on patients who have had loss of limb. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Immunosuppression
- What is being tested?
- Belatacept and Hand transplant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Patients from 18-65 years old with loss of limb
- Willingness and legal ability to give informed consent
- Willingness to travel to study site for protocol specific samples to be taken, or in some cases, the ability to send samples via overnight mail
Who cannot join
- Any condition that precludes serial follow-up
- Any condition that would likely increase the risk of protocol participation or confound the interpretation of the data
- Any active malignancy or any history of a malignancy or lymphoma
- Inability or unwillingness to comply with protocol monitoring and therapy and immunodeficiency syndrome(s)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
About this study
The purpose of this study is to determine the safety and efficacy of hand transplantation as a treatment for patients with loss of limb below the elbow, The study will focus on patients who have had loss of limb. The primary endpoint is the ability to use the tranplanted limb in activities of daily living at 18 months following transplantation measured by a quantitative functional test.
Study activities include several study visits over 18 months and include; demographics, medical history, vital signs, psychosocial evaluation, urine, blood test, chest x-ray, bone density scans, and biopsies. Subjects who are 18-65 and willing to travel to site and have loss of limb will be included in study evaluation.
Risks of the study include risk of rejection and infection after being transplanted. Additional risk are associated with procedures that include blood draws, biopsies, x-rays, and potential loss of confidentiality. All patient data will be kept electronically and in accordance with the requirements of Duke University. In addition to the experimental data, this database includes recipient and donor demographics and transplant relevant medical history, range of motion, sensation, and immunosuppressive medications. Data will be recorded and reported in accordance with the standards required by the United Network for Organ Sharing (UNOS).
- Conditions
- Immunosuppression
- Being tested
- Belatacept, Hand transplant
- Keywords
- hand transplantation, amputation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelataceptDrug
Also called Nulojix
This study will also test a new immunosuppressant drug called Nulojix® (belatacept) to see if it is able to prevent rejection in a hand transplant. Nulojix® (belatacept) is approved by the FDA for use in kidney transplants; however, it is investigational in this study.
Hand transplantProcedure or surgery
The purpose of this study is to see if a surgical procedure for transplantation of a hand from a deceased donor can help subjects perform daily living activities better than they are currently able to do.
| Study group | Role | What they receive |
|---|---|---|
| Hand transplant with Belatacept | Experimental | Not described Receives: Drug: Belatacept; Procedure: Hand transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to use the tranplanted limb in activities of daily living at 18 months following transplantation measured by a quantitative functional test.
Measured: 18 months
Secondary outcomes (2)
Clinical rejection
Presence of macroscopic changes in the skin like a rash
Measured: 18 months
Histological rejection
Presence of infiltrates categorized by the Banff classification
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunosuppressionStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linda Cendales
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Linda Cendales, Duke University
- Investigators
- Linda Cendales, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310867
- Sponsor's protocol ID
- Pro00056079
- Status last verified
- Apr 2026
- First submitted
- 4 Dec 2014
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy
- ClinicalTrials.gov ID
- NCT02310867
- Acronym / sponsor ID
- Pro00056079
- Conditions
- Immunosuppression
- Keywords
- hand transplantation, amputation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Linda CendalesUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 8 Dec 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 purpose of this study is to determine the safety and efficacy of hand transplantation as a treatment for patients with loss of limb below the elbow, The study will focus on patients who have had loss of limb. The primary endpoint is the ability to use the tranplanted limb in activities of daily living at 18 months following transplantation measured by a quantitative functional test.
Study activities include several study visits over 18 months and include; demographics, medical history, vital signs, psychosocial evaluation, urine, blood test, chest x-ray, bone density scans, and biopsies. Subjects who are 18-65 and willing to travel to site and have loss of limb will be included in study evaluation.
Risks of the study include risk of rejection and infection after being transplanted. Additional risk are associated with procedures that include blood draws, biopsies, x-rays, and potential loss of confidentiality. All patient data will be kept electronically and in accordance with the requirements of Duke University. In addition to the experimental data, this database includes recipient and donor demographics and transplant relevant medical history, range of motion, sensation, and immunosuppressive medications. Data will be recorded and reported in accordance with the standards required by the United Network for Organ Sharing (UNOS).
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 with Belatacept | Experimental | Drug: Belatacept, Procedure: Hand transplant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients from 18-65 years old with loss of limb
- Willingness and legal ability to give informed consent
- Willingness to travel to study site for protocol specific samples to be taken, or in some cases, the ability to send samples via overnight mail
Key exclusion criteria (4 listed)
- Any condition that precludes serial follow-up
- Any condition that would likely increase the risk of protocol participation or confound the interpretation of the data
- Any active malignancy or any history of a malignancy or lymphoma
- Inability or unwillingness to comply with protocol monitoring and therapy and immunodeficiency syndrome(s)
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 |
|---|---|---|
| BelataceptAlso: NulojixThis study will also test a new immunosuppressant drug called Nulojix® (belatacept) to see if it is able to prevent rejection in a hand transplant. Nulojix® (belatacept) is approved by the FDA for use in kidney transplants; however, it is investigational in this study. | Drug | Hand transplant with Belatacept |
| Hand transplantThe purpose of this study is to see if a surgical procedure for transplantation of a hand from a deceased donor can help subjects perform daily living activities better than they are currently able to do. | Procedure or surgery | Hand transplant with Belatacept |
Primary outcome
Ability to use the tranplanted limb in activities of daily living at 18 months following transplantation measured by a quantitative functional test.
Time frame: 18 months
2 secondary outcomes
Clinical rejection
Time frame: 18 months
Histological rejection
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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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.
Linda Cendales, MD principal investigator
Duke University
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 Belatacept and Hand transplant in people with Immunosuppression, run by Linda Cendales 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 3 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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linda Cendales, MD (919-681-7514, linda.cendales@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to use the tranplanted limb in activities of daily living at 18 months following transplantation measured by a quantitative functional test. (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 9 Apr 2026.