Clinical Trial

Expansion of Virus-Specific Lymphocytes for Cell Therapy

Recruiting Phase 1
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Record status
This record was last updated October 24, 2024 (before its estimated June 10, 2025 completion). Its status may not reflect the trial's current state.
Summary
Infections and reactivation of human cytomegalovirus (CMV), adenovirus, Epstein-barr and polyoma virus infections are frequent causes of morbidity and mortality and are a source of serious complications in patients undergoing allogeneic bone marrow transplantation. In this project we will prepare specific T lymphocytes from blood donor, select cells CMV-specific by interferon gamma capture and treat patients with CMV viral infections. These cells will be used as antiviral therapy in transplanted patients whom do not respond to conventional therapies or in patients whose conventional therapy may be toxic in the context of transplantation. In this context, CMV reactivation can lead to serious complications in patients, such as irreversible neurological changes, pulmonary, gastrointestinal and ophthalmologic complications, among others, in addition to prolonged hospitalizations, leading to significant morbidity and mortality , both in the health sector public as private. This project may represent an important therapeutic modality using cell of the shelf as a source of therapy for different patients and contributing to reduced morbidity / mortality after transplantation, as well as a reduction in the hospitalization period.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-08-21.
Trial Details
NCT Number NCT06011486
Lead Sponsor Hospital Israelita Albert Einstein
Conditions CMV Viremia, CMV
Enrollment 10 participants
Start Date 2024-06-10
Primary Completion 2025-06-10 (estimated)
Study Completion 2026-06-10 (estimated)
Updated on ClinicalTrials.gov 2024-10-24