Withdrawal of Immunosuppression in Recipients of Face and Extremity Transplants

NCT ID: NCT01853111

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-01
• Study Completion Date: 2020-03-10

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.

Conditions

Vascularized Composite Allotransplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interleukin 2

Subjects who receive a tolerogenic drug protocol

Group Type: EXPERIMENTAL

Interleukin-2

Intervention Type: BIOLOGICAL

Interventions

Interleukin-2

Intervention Type: BIOLOGICAL

Other Intervention Names

Aldesleukin, proleukin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bodhan Pomahac

Director, Plastic Surgery Transplantation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bohdan Pomahac, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2012P001539

Identifier Type: -

Identifier Source: org_study_id