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Withdrawal of Immunosuppression in Recipients of Face and Extremity Transplants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01853111
Recruitment Status : Completed
First Posted : May 14, 2013
Last Update Posted : January 27, 2021
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Bodhan Pomahac, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Vascularized Composite Allotransplantation Biological: Interleukin-2 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biomarker-guided Withdrawal of Immunosuppression in Recipients of Vascularized Composite Tissue Transplants
Actual Study Start Date : March 1, 2014
Actual Primary Completion Date : December 20, 2019
Actual Study Completion Date : March 10, 2020

Arm Intervention/treatment
Experimental: Interleukin 2
Subjects who receive a tolerogenic drug protocol
Biological: Interleukin-2
Other Name: Aldesleukin, proleukin

Primary Outcome Measures :
  1. Complete cessation of immune suppression without evidence of rejection for more than 6 months. [ Time Frame: 6 -24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01853111

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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
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Principal Investigator: Bohdan Pomahac, MD Brigham and Women's Hospital
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Responsible Party: Bodhan Pomahac, Director, Plastic Surgery Transplantation, Brigham and Women's Hospital Identifier: NCT01853111    
Other Study ID Numbers: 2012P001539
First Posted: May 14, 2013    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
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Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents