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Withdrawal of Immunosuppression in Recipients of Face and Extremity Transplants

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ClinicalTrials.gov Identifier: NCT01853111
Recruitment Status : Completed
First Posted : May 14, 2013
Last Update Posted : January 27, 2021
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Bodhan Pomahac, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE May 10, 2013
First Posted Date  ICMJE May 14, 2013
Last Update Posted Date January 27, 2021
Actual Study Start Date  ICMJE March 1, 2014
Actual Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2013)
Complete cessation of immune suppression without evidence of rejection for more than 6 months. [ Time Frame: 6 -24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Withdrawal of Immunosuppression in Recipients of Face and Extremity Transplants
Official Title  ICMJE Biomarker-guided Withdrawal of Immunosuppression in Recipients of Vascularized Composite Tissue Transplants
Brief Summary Many patients suffer from devastating injuries to vascularized composite tissues. Vascularized composite tissues are blocs of functional tissue that can contain multiple tissue types such as bone, muscle, nerves, blood vessels, tendons, ligaments, and others. Examples of patients with severe vascularized composite tissue defects include limb amputees, patients with third-degree burns to the face or extremities, soldiers with improvised-explosive-device blast injuries to the face, and others. These patients cannot be helped satisfactorily with conventional reconstructive surgery; however, recently vascularized composite allotransplantation (VCA) such as transplantation of faces and limbs became available to this patients. Unfortunately, at this juncture, patients who receive VCA must submit to life-long regime of immunosuppressant drugs with serious side effects such as infection, renal toxicity and cancer. Immune tolerance is the absence of a destructive immune response from the recipient's body to the transplant, while otherwise maintaining sufficient immune function to fight infections and other threats. Transplant recipients with immune tolerance do not need to take immunosuppression drugs. The investigators believe that they can achieve immune tolerance in recipients of face and limb transplants.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vascularized Composite Allotransplantation
Intervention  ICMJE Biological: Interleukin-2
Other Name: Aldesleukin, proleukin
Study Arms  ICMJE Experimental: Interleukin 2
Subjects who receive a tolerogenic drug protocol
Intervention: Biological: Interleukin-2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2017)
1
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2013)
30
Actual Study Completion Date  ICMJE March 10, 2020
Actual Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adults who have received VCA transplants at Brigham and Women's Hospital
  • no less than 3 months elapsed since VCA transplant,
  • on steroid-free immune dual immunosuppression with tacrolimus (6-8 ng/ml trough levels) and mycophenolate mofetil,
  • no current concerns of rejection

Exclusion Criteria:

  • recent (<3 months) episodes of rejection,
  • active bacterial or viral infection,
  • malignancy,
  • non-healing wounds
  • pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01853111
Other Study ID Numbers  ICMJE 2012P001539
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bodhan Pomahac, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Beth Israel Deaconess Medical Center
Investigators  ICMJE
Principal Investigator: Bohdan Pomahac, MD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP