Therapeutic Treatment Options: Chronic Blood Transfusions Bone Marrow Transplantation. Marianne E. McPherson Yee, MD, MSc

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1 Therapeutic Treatment Options: Chronic Blood Transfusions Bone Marrow Transplantation Marianne E. McPherson Yee, MD, MSc

2 Sickle Cell Treatment Options Supportive Care Newborn Screen PCN Immunizations Education Disease Interventions Hydroxyurea Transfusion therapy Iron chelation therapy Curative Bone Marrow Transplantation (BMT) Gene Therapy 2

3 Chronic Transfusion Therapy Goals: Prevention of sickle-related complications (acute and chronic) Decrease sickle hemoglobin (HbS) by: Replacement of sickle RBC with non-sickle RBC Suppression of erythropoiesis Acute Chest Stroke 3

4 Chronic Transfusion Therapy Different types of transfusion therapy: Simple Partial Manual Exchange Automated Exchange (Erythrocytapheresis) Packed RBC transfusions ml/kg every 3-5 weeks Chelation therapy required to remove excess iron burden Phlebotomy of whole blood Transfusion of prbc Every 3-5 weeks Reduces rate of iron accumulation Apheresis machine Double IV access Minimal net gain of iron Fasano, CNMC 4

5 Chronic Transfusion Therapy Indications: Short-Term Short period of transfusion therapy during a recovery from severe SCD event Duration: ~6 mo to 2 yrs Examples: Splenic sequestration Severe acute chest syndrome Long-Term Lifelong chronic transfusion therapy for individuals at high stroke risk: Previous overt stroke Abnormal TCD Consider for Silent MRI/A findings: Silent stroke Cerebrovascular stenosis 5

6 Stroke Prevention in Sickle Cell Disease Primary Stroke Prophylaxis Transcranial Doppler (TCD) ultrasound screening Abnormally high TCD velocity Without transfusions With transfusions Future Stroke Risk 40% within 3 years <1% per year (90% risk reduction) Secondary Stroke Prophylaxis History of Overt Stroke Without transfusions With transfusions Future Stroke Risk 67% (majority within 3 years) ~13% risk Adams et al. Arch Neurol Peglow et al. J Pediatr 1995 Verdizco et al. Blood

7 Stroke Prevention in Sickle Cell Disease Silent Stroke SIT study: RTC of transfusion therapy for asymptomatic HbSS children who had ischemic changes identified on screening brain MRI Silent Stroke Overt/Silent Stroke Risk Without transfusions 14% With transfusions 6% DeBaun et al. NEJM

8 Risks of Chronic Blood Transfusions 1. Iron Overload Chelation therapy required after ~10 to 20 transfusions Burdensome on patients, leads to adherence problems Effects of hemosiderosis: Liver fibrosis Heart failure Endocrine effects: Growth failure, puberty delay, diabetes, hypothyroid ism. = 250 mg of iron accumulation * 8

9 Risks of Chronic Blood Transfusions 2. Alloimmunization Up to 35-40% of multiply-transfused SCD population Risks: Hemolytic transfusion reactions New alloimmunization events Difficulty finding compatible blood in emergency situation. 3. Infectious disease risks HIV (1:1,467,000), HCV (1:1,149,000), HBV (1:843,000)* * 9

10 Bone Marrow Transplantation Curative therapy for sickle cell disease Center for International Blood & Marrow Transplant Research (CIBMTR): Nearly 900 sickle cell patients have received BMT todate Over 750 were age < 21 years Approx 400 from present Survival Statistics for Matched Related Donors: 93% overall survival 85% EFS 10

11 Bone Marrow Transplantation Barriers to Transplant: TOXICITY Short Term: immunosuppression, infection, graft-vs-host, acute organ dysfunction Long Term: chronic graft-vs-host, chemotherapy late effects, infertility DONOR AVAILABILITY Matched Related Donor Least morbidity; Majority lack a related donor Alternative Donors Matched Unrelated; Cord Blood; Haplo-identical 11

12 Eligibility for BMT Traditional Criteria Suitable Donor Patient Age Severe Genotype Severe Phenotype HLA-identical sibling donor Under 16 years old HbSS HbSβ 0 thalassemia Stroke risk Multiple ACS Frequent VOC Pain Chronic organ damage: - Nephropathy - Retinopathy - Osteonecrosis Alloimmunization in patient requiring chronic transfusions 12

13 Eligibility for BMT New Considerations 1. Focus on the DONOR Type to make BMT available to more patients DONOR If HLA-matched related donor If no HLA-matched related available SCD Genotype & Phenotype Consider MRD-BMT for Children with less severe complications Other genotypes (SC, Sβ + thalassemia) Consider alternative donor BMT for patients who have severe genotype and phenotypes: Matched Unrelated Donors (NMDP) Haplo-identical related Donors 2. AGE: Protocols for BMT in Adults with SCD, including sibling or matched unrelated donors 13

14 Alternative Donor Clinical Trials Unrelated Donor, Reduced Intensity trial (SCURT) Cord blood arm closed early due to high graft rejection r Bone Marrow arm: 86% OS, 76% EFS at 1 year, 10% rejection, 38% extensive chronic GVHD (main cause of mortality) Pilot study of BMT in adults with SCD (STRIDE) 17 received MSD, 5 received MUD 20/22 overall survival (median 9.7 mo follow up) Jan 2016: larger trial comparing BMT to Standard of care Shenoy, NHLBI sickle clinical research meetings

15 Emory pediatric BMT experience 64 sickle cell patients transplanted at CHOA to-date Matched sibling donor BMT considered a standard of care for moderate/severe SCD Matched Sibling Donors Matched Unrelated, or Partially-matched related donors N=57 N=7 - One 7/8 HLA-matched sibling - 2 unrelated cord bloods - 4 matched unrelated donors 55/57 (96.5%)overall survival 1 non-engraftment 5/7 (71.4%) overall survival Mortality from Chronic GVHD 15

16 Future Directions Gene Therapy for SCD Early clinical trials (current Phase I) Autologous HSCT of patient s bone marrow stem cells that have undergone genetic transfer of anti-sickling gene a modified β-globin gene that inhibits HbS polymerization Lentiviral vector transmission Eliminates problems of donor availability or graft-vs-host complications of allogeneic HSCT 16

17 Thank you

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