Novel Strategies to Improve Immunomodulation and Non-invasive Clinical Monitoring in VCA (NCT03241719) | Clinical Trial Compass
TerminatedEarly Phase 1
Novel Strategies to Improve Immunomodulation and Non-invasive Clinical Monitoring in VCA
Stopped: No participants are currently receiving therapy under this protocol, funding is coming to an end and the PI is leaving the institution.
United States2 participantsStarted 2017-10-17
Plain-language summary
The objective of this study is to develop a feasible and safe regimen for minimization of immune suppression in recipients of vascularized composite allotransplants (VCA) using a daily dose of recombinant IL-2. In order to achieve this aim, this trial will:
1. Perform VCA in 5 eligible subjects;
2. Administer recombinant IL-2 at a low-dose to promote the expansion and function of regulatory T cells in subjects who received VCA; and
3. Minimize immune suppression to tacrolimus single therapy in subjects who received VCA and recombinant IL-2.
This trial will also investigate if it is possible to predict immune rejection in VCA using blood and tissue samples from recipients of VCA.
Lastly, this trial will develop non-invasive technologies to monitor for VCA rejection. These technologies will involve magnetic resonance imaging. Multi-contrast ultra-high resolution MR imaging (MRI) with serial direct planimetry will be performed in recipients of VCA.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
For the VCA portion of the study:
* Patients referred due to one or more of these conditions: (1) severe facial deformity comprising more than 25% of the facial area and/or one or more of the central facial units (i.e. lip(s), nose, eye(s)), (2) single or bilateral upper limb(s) amputation, where at least one of the limbs was amputated at the level of the wrist or more proximal, up to the functional shoulder joint, and (3) severe abdominal wall defect comprising more than 50% of the functional abdominal wall.
* Injuries must have taken place no more than 15 years and no less than 6 months prior to presentation for consideration.
* All other conventional reconstruction approaches will have been either exhausted, or ruled out due to poor prognosis of outcomes.
* Patients will need to possess strong motivation and a willingness to commit to post-transplant rehabilitation.
* Normal renal and hepatic function within acceptable medical parameters
For the recombinant IL-2 phase of the study:
* At least 3 months have elapsed since the VCA transplant operation
* At least 4 weeks on stable immune suppression and steriods (\<5 mg QD).
* No addition or subtraction of other immunosuppressive medications for 4 weeks prior to enrollment. The dose of immunosuppressive medicines may be adjusted based on the therapeutic range for that drug.
* Medical evaluations, clinical and laboratory assessments must deem that participants have adequate organ function.
* The effects …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.