Withdrawal of Immunosuppression in Recipients of Face and Extremity Transplants

NCT01853111 | Completed Phase 1

• 1 other identifier: 2012P001539
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  6 -24 months

Study Arms (1)

Interleukin 2

EXPERIMENTAL

Subjects who receive a tolerogenic drug protocol

Biological: Interleukin-2

Interventions

Interleukin-2 BIOLOGICAL

Also known as: Aldesleukin, proleukin

Interleukin 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• recent (\<3 months) episodes of rejection,
• active bacterial or viral infection,
• malignancy,
• non-healing wounds
• pregnancy

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Interleukin-2; aldesleukin

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Bohdan Pomahac, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Plastic Surgery Transplantation

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 14, 2013
• Study Start: March 1, 2014
• Primary Completion: December 20, 2019
• Study Completion: March 10, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

US (1)