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OpenTrials
Completed

NCT Number: NCT01853111

Withdrawal of Immunosuppression in Recipients of Face and Extremity Transplants

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interleukin-2

Biological

Other names: Aldesleukin, proleukin

Primary outcomes

  1. Complete cessation of immune suppression without evidence of rejection for more than 6 months.

    Time frame: 6 -24 months

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Beth Israel Deaconess Medical Center

Registry information

Official study title

Biomarker-guided Withdrawal of Immunosuppression in Recipients of Vascularized Composite Tissue Transplants

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
May 14, 2013
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.