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Mobilization and Collection of Peripheral Blood Stem Cells in Patients With Fanconi Anemia Using G-CSF and Plerixafor
Bu çalışma, Fanconi anemisi (Fanconi anemia) olan çocuklarda G-CSF ve Plerixafor ilaçları kullanılarak periferik kandan kök hücre toplanmasını incelemektedir. 2-17 yaş arası, uygun HLA-uyumlu kardeş vericisi bulunmayan ve nakil için değerlendirilen çocuklar katılabilmektedir. Çalışma Faz 1/Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Patient with Fanconi anemia * Patient from 2 to 17 years old * Potential indication for allogenic bone arrow graft without HLA-identical brotherhood available * Patient's weight \>10kg * Treated and followed for at least the previous two years in a specialized center where they got a full assessment of their disease * For women of childbearing age, not pregnant and use of an effective contraception during the entire participation in the research. * Affiliated or beneficiary of an health insurance regimen * Informed and signed consent Exclusion Criteria: * Patient unable to follow the visits required by the protocol * Positive serology for HIV-1/2, HTLV-1/2, HCV and HbS * Bacterial, viral, fungal or parasitic active infection with clinical signs * Personal history of cancer, myeloproliferative hematopathy or immune deficiency * Heart failure and / or heart rhythm disorder * History of allogeneic graft of hematopoietic stem cells * Patient with an HLA-identical brotherhood donor available * Myelodysplasia diagnose on myelogram * Cytogenetic abnormality on karyotype * Malignant solid tumor * Documented spontaneous genetic reversion of medullary process * Diagnosis of a psychiatric disorder that could compromise his/her ability to participate in the study * Any disorder according to the investigator, that could compromise the ability of patient to give his writing consent and/or to comply with requiring study's procedures * Current Pregnancy * Heart, kidney or liver failure * Current participation in another interventional clinical trial * Patient under Medical Assistance State * Hypersensitivity to plerixafor or any excipient contained in MOZOBIL® * Hypersensitivity to filgrastim or any of its' excipient