JULIANA FOLLONI FERNANDES

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Instituto da Criança, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/36 - Laboratório de Pediatria Clínica, Hospital das Clínicas, Faculdade de Medicina

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  • article 6 Citação(ões) na Scopus
    Multicenter Long-Term Follow-Up of Allogeneic Hematopoietic Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials
    (2023) LIN, Chenyu; SCHWARZBACH, Aurelie; SANZ, Jaime; MONTESINOS, Pau; STIFF, Patrick; PARIKHA, Suhag; BRUNSTEIN, Claudio; CUTLER, Corey; LINDEMANS, Caroline A.; HANNA, Rabi; KOH, Liang Piu; JAGASIA, Madan H.; VALCARCEL, David; MAZIARZ, Richard T.; KEATING, Amy K.; HWANG, William Y. K.; REZVANI, Andrew R.; KARRAS, Nicole A.; FERNANDES, Juliana F.; ROCHA, Vanderson; BADELL, Isabel; RAM, Ron; SCHILLER, Gary J.; VOLODIN, Leonid; WALTERS, Mark C.; HAMERSCHLAK, Nelson; CILLONI, Daniela; FRANKFURT, Olga; MCGUIRK, Joseph P.; KURTZBERG, Joanne; SANZ, Guillermo; SIMANTOV, Ronit; HORWITZ, Mitchell E.
    Omidubicel is an umbilical cord blood (UCB)-derived ex vivo-expanded cellular therapy product that has dem-onstrated faster engraftment and fewer infections compared with unmanipulated UCB in allogeneic hematopoietic cell transplantation. Although the early benefits of omidubicel have been established, long-term outcomes remain unknown. We report on a planned pooled analysis of 5 multicenter clinical trials including 105 patients with hematologic malignancies or sickle cell hemoglobinopathy who underwent omidubicel transplantation at 26 academic transplantation centers worldwide. With a median follow-up of 22 months (range, .3 to 122 months), the 3-year estimated overall survival and disease-free survival were 62.7% and 56.4%, respectively. With up to 10 years of follow-up, omidubicel showed durable trilineage hematopoiesis. Serial quantitative assessments of CD3(+), CD4(+), CD8(+), CD19(+), CD116(+)CD56(+), and CD123(+) immune subsets revealed median counts remaining within normal ranges through up to 8 years of follow-up. Secondary graft failure occurred in 5 patients (5%) in the first year, with no late cases reported. One case of donor-derived myeloid neoplasm was reported at 40 months post-transplantation. This was also observed in a control arm patient who received only unmanipulated UCB. Overall, omidubicel demonstrated stable trilineage hematopoiesis, immune competence, and graft durability in extended follow-up. (c) 2023 The American Society for Transplantation and Cellular Therapy.
  • article 2 Citação(ões) na Scopus
    Umbilical Cord Mesenchymal Stromal Cells for Steroid-Refractory Acute Graft-versus-Host Disease
    (2023) DONADEL, Camila Derminio; PIRES, Bruno Garcia; ANDRE, Nathalia Cristine; COSTA, Thalita Cristina Mello; ORELLANA, Maristela Delgado; CARUSO, Samia Rigotto; SEBER, Adriana; GINANI, Valeria Cortez; GOMES, Alessandra Araujo; NOVIS, Yana; BARROS, George Mauricio Navarro; VILELLA, Neysimelia Costa; MARTINHO, Glaucia Helena; VIEIRA, Ana Karine; KONDO, Andrea Tiemi; HAMERSCHLAK, Nelson; FILHO, Jayr Schmidt; XAVIER, Erick Menezes; FERNANDES, Juliana Folloni; ROCHA, Vanderson; COVAS, Dimas Tadeu; CALADO, Rodrigo Tocantins; GUERINO-CUNHA, Renato Luiz; SANTIS, Gil Cunha De
    Background: Steroid-refractory acute graft-vs.-host disease (SR-aGVHD) is a complication of allogeneic hematopoietic stem cell transplantation with a dismal prognosis and for which there is no consensus-based second-line therapy. Ruxolitinib is not easily accessible in many countries. A possible therapy is the administration of mesenchymal stromal cells (MSCs). Methods: In this retrospective study, 52 patients with severe SR-aGVHD were treated with MSCs from umbilical cord (UC-MSCs) in nine institutions. Results: The median (range) age was 12.5 (0.3-65) years and the mean +/- SD dose (x10(6)/kg) was 4.73 +/- 1.3 per infusion (median of four infusions). Overall (OR) and complete response (CR) rates on day 28 were 63.5% and 36.6%, respectively. Children (n = 35) had better OR (71.5% vs. 47.1%, p = 0.12), CR (48.6% vs. 11.8%, p = 0.03), overall survival (p = 0.0006), and relapse-free survival (p = 0.0014) than adults (n = 17). Acute adverse events (all of them mild or moderate) were detected in 32.7% of patients, with no significant difference in children and adult groups (p = 1.0). Conclusions: UC-MSCs are a feasible alternative therapy for SR-aGVHD, especially in children. The safety profile is favorable.