Overview

Lentiviral-mediated Gene Therapy of Fanconi Anemia Patients Subtype A

Status:
Active, not recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
Summary
This is an open, Phase I / II clinical trial to evaluate the safety and efficacy of a hematopoietic gene therapy procedure with an orphan drug consisting of a lentiviral vector carrying the FANCA gene for patients with Fanconi Anemia of Subtype A . CD34 + cells derived from bone marrow and / or mobilized peripheral blood (fresh and / or cryopreserved) from patients with Fanconi subtype A (FA-A), will be transduced ex vivo with a lentiviral vector carrying the gene FANCA (orphan drug) . After transduction the cells will be inoculated in patients in order to restore their hematopoiesis with genetically corrected stem cells.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Collaborators:
Centro de Investigación en Red de Enfermedades Raras (CIBERER)
Centro de Investigaciones Energéticas, Medioambientales y Tecnológicas (CIEMAT)
Hospital Vall d'Hebron
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Universitat Autonoma de Barcelona
Treatments:
JM 3100
Lenograstim
Plerixafor
Sargramostim