Novel Strategies to Improve Immunomodulation and Non-invasive Clinical Monitoring in VCA
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|ClinicalTrials.gov Identifier: NCT03241719|
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : July 19, 2018
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:
- Perform VCA in 5 eligible subjects;
- Administer recombinant IL-2 at a low-dose to promote the expansion and function of regulatory T cells in subjects who received VCA; and
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Amputation, Traumatic Amputation;Traumatic;Old Face Injury Face; Deformity Abdominal Wall Defect||Drug: IL-2||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Novel Strategies to Improve Immunomodulation and Non-invasive Clinical Monitoring in Vascularized Composite Allotransplantation|
|Actual Study Start Date :||October 17, 2017|
|Estimated Primary Completion Date :||August 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Subjects who receive transplantation and undergo IL-2 treatment
Subjects will receive vascularized composite allotransplantation (e.g. facial, hand and/or abdominal wall transplants) under conventional immune suppression. No sooner than 3 months after VCA, subjects will receive a protocol of daily recombinant IL-2 at low doses for 8 weeks.
- Number of regulatory T cells [ Time Frame: 4-24 months ]
- Number of episodes of rejection [ Time Frame: 1-24 months ]
- T-cell alloreactivity measured by ELISPOT [ Time Frame: 4-24 months ]
- Steroid dose [ Time Frame: 6-24 months ]
- Mycophenolate dose [ Time Frame: 8-24 months ]
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): NCT03241719
|Contact: Jessica Detmer-Lillardfirstname.lastname@example.org|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Ashley Tremblay 617-732-7796 email@example.com|
|Contact: Elaine Devine, LSW 617-732-6967 firstname.lastname@example.org|
|Principal Investigator:||Bohdan Pomahac, MD||Brigham and Women's Hospital|