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Trial record 5 of 27 for:    Recruiting, Not yet recruiting, Available Studies | "Facial Injuries"

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 : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Bodhan Pomahac, Brigham and Women's Hospital

Brief 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.


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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Subjects who receive transplantation and undergo IL-2 treatment
Drug: IL-2
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.




Primary Outcome Measures :
  1. Number of regulatory T cells [ Time Frame: 4-24 months ]

Secondary Outcome Measures :
  1. Number of episodes of rejection [ Time Frame: 1-24 months ]
  2. T-cell alloreactivity measured by ELISPOT [ Time Frame: 4-24 months ]
  3. Steroid dose [ Time Frame: 6-24 months ]
  4. Mycophenolate dose [ Time Frame: 8-24 months ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 as below:

ALT ( Alanine aminotransferase) 7-55 U/L AST (Aspartate aminotransferase) 8-48 U/L ALP (Alkaline phosphatase) 45-115 U/L Albumin 3.5-5.0 g/dL Total protein 6.3-7.9 g/dL Bilirubin 0.1-1.0 mg/dL GGT (Gamma glutamyl transpeptidase) 0-30 U/L LDH (Lactate dehydrogenase) 122-222 mcmol/L PT (Prothrombin Time) 10.9-12.5 seconds Blood Urea Nitrogen (BUN) 7-20mg/100ml Serum Creatinine Adult males 0.8 - 1.4 mg/dl Adult females 0.6 -1.1mg/dl Creatinine Clearance Adult males 97-137 ml/min Adult females 88-128 ml/min Pregnancy May be as high as 150 - 200 ml/min.

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 of low dose tacrolimus (trough levels ~ 6-8 ng/ml) and mycophenolate (<1000 mg BID mycophenolate mofetil (MMF) or <720 mg BID Myfortic) and prednisone (<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 of some of the study drugs on the developing human fetus are unknown, or toxic. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence prior to study entry and for the duration of study participation). Should a women become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Subjects must be able to understand and willing to sign a written informed consent document.
  • Skin biopsies from the transplanted parts must show no evidence of rejection for at least 3 months prior to study enrollment.

Exclusion Criteria:

For the VCA portion of the study:

  • History of poor compliance with prostheses or rehabilitation
  • Impaired renal, cardiac and/or pulmonary function
  • Compromised ability to understand the risk and benefits of participation in the study
  • Active malignancy
  • Single non-dominant upper limb amputation and no other vascularized composite tissue injuries justifying VCA

For the IL-2 portion of the study:

  • Active infection
  • Non-healing wounds
  • Pregnancy, because of the potential for teratoenic or abortifacient effects. There is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother, therefore breastfeeding should be discontinued.
  • Rejection episodes within the past 3 months
  • Concurrent use of calcineurin-inhibitor plus sirolimus
  • New immunosuppressive medication in the 4 weeks prior
  • Post-transplant exposure to T-cell or IL-2 targeted medication (e.g. ATG, alemtuzumab, basiliximab, denileukin diftitox) within 100 days prior.
  • Active malignant relapse
  • Donor lymphocyte infusion within 100 days prior
  • Inability to comply with IL-2 treatment regime
  • HIV-positive individuals because of the potential for lethal infections.
  • Other investigational drugs within 4 weeks prior to enrollment, unless cleared by the principal investigator.

Information from the National Library of Medicine

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


Contacts
Contact: Ericka M Bueno, PhD 6177327196 ebueno@bwh.harvard.edu

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Ashley Tremblay    617-732-7796    atremblay1@bwh.harvard.edu   
Contact: Elaine Devine, LSW    617-732-6967    edevine2@bwh.harvard.edu   
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Bohdan Pomahac, MD Brigham and Women's Hospital

Responsible Party: Bodhan Pomahac, Director, Plastic Surgery Transplantation, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03241719     History of Changes
Other Study ID Numbers: 2017P000590
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Amputation, Traumatic
Wounds and Injuries