NCT03241719 is a EARLY_PHASE1 clinical trial of IL-2 in Amputation, Traumatic, sponsored by Brigham and Women's Hospital.

Who is sponsoring NCT03241719?

NCT03241719 is sponsored by Brigham and Women's Hospital.

What drugs are being tested in NCT03241719?

Interventions in NCT03241719: IL-2.

What condition does NCT03241719 study?

NCT03241719 studies Amputation, Traumatic, Amputation;Traumatic;Old, Face Injury, Face; Deformity, Abdominal Wall Defect.

Is NCT03241719 still recruiting?

NCT03241719 is currently terminated. Last updated 28 July 2021.

Last reviewed 2021-07-28 · How we verify

NCT03241719

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Novel Strategies to Improve Immunomodulation and Non-invasive Clinical Monitoring in VCA

Terminated EARLY_PHASE1 Last updated 28 July 2021

What this trial tests

EARLY_PHASE1 trial testing IL-2 in Amputation, Traumatic in 2 participants. Terminated before completion.

Timeline

17 October 2017

Primary endpoint
21 July 2021

21 July 2021

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	EARLY_PHASE1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	17 October 2017
Primary completion	21 July 2021
Estimated completion	21 July 2021
Sites	1 location across United States

Drugs / interventions tested

IL-2 — full drug profile →

Conditions studied

Amputation, Traumatic — all drugs for Amputation, Traumatic →
Amputation;Traumatic;Old — all drugs for Amputation;Traumatic;Old →
Face Injury — all drugs for Face Injury →
Face; Deformity — all drugs for Face; Deformity →

Sponsor

Brigham and Women's Hospital

Who can join

Adults 18 to 70, any sex, with Amputation, Traumatic or Amputation;Traumatic;Old. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this study is to develop a feasible and safe regimen for minimization of immune suppression in recipients of vascularized composite allotransplants (VCA) using a daily dose of recombinant IL-2. In order to achieve this aim, this trial will: 1. Perform VCA in 5 eligible subjects; 2. Administer recombinant IL-2 at a low-dose to promote the expansion and function of regulatory T cells in subjects who received VCA; and 3. Minimize immune suppression to tacrolimus single therapy in subjects who received VCA and recombinant IL-2. This trial will also investigate if it is possible to predict immune rejection in VCA using blood and tissue samples from recipients of VCA. Lastly, this trial will develop non-invasive technologies to monitor for VCA rejection. These technologies will involve magnetic resonance imaging. Multi-contrast ultra-high resolution MR imaging (MRI) with serial direct planimetry will be performed in recipients of VCA.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of IL-2

Trials testing the same drug.

NCT06158828 — Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML · Phase 1, PHASE2 · recruiting
NCT06302062 — Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors · Phase 1 · recruiting
NCT05336409 — A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies · Phase 1 · terminated
NCT05603013 — Vinorelbine Metronomic Chemotherapy Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 f · Phase 2 · unknown
NCT05400122 — Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Recepto · Phase 1 · suspended

Other recruiting trials for Amputation, Traumatic

Currently open trials in the same condition.

NCT06433648 — Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait · NA · recruiting
NCT05297266 — Early Discovery of Ischemia After Replantation Surgery of the Extremities · NA · recruiting
NCT03400345 — Human Upper Extremity Allotransplantation: F/U Protocol · recruiting
NCT01459107 — Human Upper Extremity Allotransplantation · Phase 2 · recruiting

Other Brigham and Women's Hospital trials

Trials by the same sponsor.

NCT07011758 — Dynamic Treatment Regimes for Opioid Use Disorder · Phase 2 · not yet recruiting
NCT06310018 — Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE · suspended
NCT04519177 — Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability ... · NA · not yet recruiting
NCT06355986 — Computerized Decision Support to Prevent Stroke in Atrial Fibrillation · NA · not yet recruiting
NCT06099275 — Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography · suspended

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03241719 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Brigham and Women's Hospital
Last refreshed: 28 July 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03241719.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing