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Withdrawal of Immunosuppression in Recipients of Face and Extremity Transplants

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01853111
First Posted: May 14, 2013
Last Update Posted: October 19, 2017
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.
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Bodhan Pomahac, Brigham and Women's Hospital
  Purpose
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 Intervention Phase
Vascularized Composite Allotransplantation Biological: Interleukin-2 Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Bodhan Pomahac, Brigham and Women's Hospital:

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

Enrollment: 1
Study Start Date: March 2014
Estimated Study Completion Date: January 1, 2019
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interleukin 2
Subjects who receive a tolerogenic drug protocol
Biological: Interleukin-2
Other Name: Aldesleukin, proleukin

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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): NCT01853111


Locations
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
Investigators
Principal Investigator: Bohdan Pomahac, MD Brigham and Women's Hospital
  More Information

Responsible Party: Bodhan Pomahac, Director, Plastic Surgery Transplantation, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01853111     History of Changes
Other Study ID Numbers: 2012P001539
First Submitted: May 10, 2013
First Posted: May 14, 2013
Last Update Posted: October 19, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs