Haploidentical Hematopoietic Stem Cell Transplantation: A New Transplantation Modality Implemented In a Recent Accredited FACT Institution In Latin America

Introduction The Foundation for the Accreditation of Cellular Therapy (FACT) has developed and implemented programs of voluntary inspection and accreditation for hematopoietic cellular therapy, and for cord blood banking. These programs are based on the standards of the clinical and laboratory professionals of the American Society of Blood and Marrow Transplantation (ASBMT), the International Society for Cellular Therapy (ISCT), and NETCORD. Our transplantation service was the first Hospital in Latin America to be accreditated by FACT in 2012. FACT accreditated hospitals might have a positive impact in Implementing new procedures and treatment protocols. Haploidentical SCT program was developed in our institution during FACT accreditation process. Since high complexity procedures challange transplantation units, we believe that conducting protocols after FACT accreditation helped the achievment of better standard of care that might be translated in results comparable with international transplantation centres. SCT from Haploidentical donor can be one therapeutic option specially for patients with no available MRD or MUD. In order to overcome HLA disparity, more intensive immunossupresion is usually used that can be associated to higher TRM. These difficulties demand a well stablished transplantation unit. Here we show the first 25 patients who recieved haploidentical SCT during FACT accreditation in a single institution in Brazil. Patients and methods: From april 2008 to july 2013, 25 patients were treated with haploidentical SCT. The median follow-up time was 3,3 months (range ). 8 (32%) patients had AML, 1 (4%) ALL, 1 (4%) JMML, 1(4%) LH, 1 (4%) MDS. 7 (28%) had  adrenoleukodystrophy x-linked, 3(23%) had SAA and 2(28%) SCID. 8 (33%) patinets had refreactory disease. Median age at transplantation was 3.3 (range 1-72) years. 12 (48%) patients were in pediatric age range (1 to 18) years. 13 (54%) had donor/receptor ABO incompatibility. 10 (40%) patients were transplanted after myeloablative conditioning regimen (Bussulfan/Fludarabine or Busulfan/fludarabine/thiotepa) and 15(60%) after non-myeloablative conditioning regimen (Fludarabine/cyclophosphamide/TBI200cGy). 22 (88%) patients have received bone marrow as stem cell source and 3 (12%) peripheral blood stem cells. Median total nucleated cell x 108/Kg was 5.5 (range 3.0 to 10.34). Median CD34+x106/Kg 3.61 (range 1.48 to 7.06). Post transplant immunosuppression consisted of tacrolimus/MMF plus post transplant Cyclophosphamide in 22 (88%) patients, steroids plus CsA or tacrolimus in 2 (8%) and T cell depleted graf with no immunosupression in one SCID patient. All patients engrafted by day 28 after transplantation and 4 patients had secondary graft rejection. Only one (4%) patient developed synusoidal obstruction syndrome. 7 (28%) patients developed Acute graft-verus-host disease (3 grade I/II and 4 grade III/IV). 16 patients (64%) developed CMV reactivation. At the end of the follow-up 21 (84%) were alive. Four patients died from relapse at day 100 post transplant, 2 from infection and 1 from coronary heart disease. Sencondary graft failure had a negative impact in overal survival (HR: 14 (IC: 1,2-157), p= 0,033). Conclusion: The FACT accretidation process can promote improvement and progress in stem cell transplantation process, by controlling every aspect that impacts the quality of products and therapeutic care. In our center, there was a process developed in order to meet FACT standards that brought better patient care. We have shown the first 25 haploidentical patients who was treted after this accreditation, showing similar results when comparing to international centres and previous publications. We believe that these results could only be achieved in a transplant unit that meets specific quality control guided by FACT. Disclosures: No relevant conflicts of interest to declare.