Bone Marrow, Peripheral Blood Stem Cells or Umbilical Cord Blood transplantation? Federica Giannotti, MD Eurocord-Hôpital Saint Louis, Paris

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1 Bone Marrow, Peripheral Blood Stem Cells or Umbilical Cord Blood transplantation? Federica Giannotti, MD Eurocord-Hôpital Saint Louis, Paris

2 Background Hematopoietic stem cell transplantation (HSCT) is an important and potentially curative treatment option for a wide variety of malignant and non malignant hematological diseases Multipotent HSCs (CD34+) are capable of: -homing to the bone marrow after infusion -self renewal -differentiation into progenitor cells

3 Sources of HSCs Bone Marrow (BM) Peripheral Blood (PB) Umbilical Cord Blood (UCB) Aspirated from the posterior iliac crests under either local or general anesthesia Filtered and directly infused Following mobilization (with growth factors) Collected by apheresis Collected at birth Processed and cryopreserved in CB banks

4 Type of donors Autologous Patient s own HSCs Syngeneic donor (identical twin) HLA-MATCHED (M) Allogeneic Related donor (sibling or other relative) HLA-M or HLA- MISMATCHED (MM) or HAPLOIDENTICAL Unrelated donor HLA-M or HLA-MM

5 HLA (Human Leukocyte Antigen) Complex of closely linked genes encoding for the human major histocompatibility complex (MHC), related to immune system functions as the recognition of the non-self I HLA class I (loci A, B, C) and HLA class II (loci HLA-DR, -DQ and - DP); high degree of allele polymorphism at each locus Inherited as haplotypes (1 maternal and 1 paternal) II HLA typed to match the donor with the recipient: - at loci A, B and DRB1 for UCB (6 loci) - at loci A, B, C and DRB1 for related donor (8 loci) - at loci A, B, C, DRB1 and DPB1 for unrelated adult donor (10 loci) Matched, Mismatched, Haploidentical Donor

6 Autologous HSCT To cure malignant diseases and severe autoimmune disorders High-dose chemotherapy (with or without TBI) To eradicate the tumor cells (HL, NHL, MM, Amyloidosis, AL) To reset the immune system (MS, DM type I, LES, ecc ) Infusion of patient s previously collected and cryopreserved HSCs To ensure recovery of bone marrow function

7 Autologous HSCT Virtually all performed with PBSCs collected from the patient by apheresis after mobilization With chemotherapy and hematopoietic growth factor With hematopoietic growth factor alone Easier harvest + more rapid immuno-hematopoietic recovery > safety and tolerability

8 Allogeneic HSCT To cure malignant and non malignant disorders MA, NMA or RI conditioning chemotherapy (with or without TBI) - Eradicate the malignancy - Create space to host donor s HSCs - Immunosuppression to prevent graft rejection -Create space to host donor s HSCs - Immunosuppression to prevent graft rejection Infusion of donor s HSCs Graft versus tumor effect (AML, ALL, MDS, MPN, HL, NHL, MM) Recipient s hematopoiesis replacement (Hbpathies, BMFS, Metabolic disorders, Immune deficiencies, ecc) Immunosuppressive prophylaxis to prevent GvHD

9 Allogeneic HSCT Critical issues affecting outcomes* Patient-related features (age, gender, CMV serostatus, comorbidities ) Conditioning regimen GvHD prophylaxis Prior therapy (type of chemo, high dose chemo ) and diseaserelated features (type, stage, kinetics ) HSCT timeline Infusion day 0 HSCs source & Donor type Supportive care and prevention of relapse *Survival, Engraftment, Morbidity (GvHD, immunological reconstitution, infections), Disease control (GvL effect)

10 Allogeneic HSCT The selection of a donor is a critical element contributing to the success of HSCT Initially. HLA-matched sibling BM; HSCT in children and young adults Reports on HSCT activity (Baldomero et al. EBMT survey 2009; WMDA data) showed use of PBSCs (71% of allo HSCT) use of alternative donors (MUD and MMUD PB/BM; related&unrelated UCB, haploidentical relatives PB/BM) > donor/hscs source choice > centre expertise (supportive care, GvHD&infection prophylaxis, RIC regimens) Extension of HSCT indications (adults, older patients) Improved outcomes and results

11 The ideal HSCs source Immediate availability Few HLA restrictions & adequate cell dose Absence of risk for the donor Applicable to all diseases and all ages Associated with: - rapid immuno-hematopoietic recovery - potent graft versus malignancy effect - little risk of acute and chronic GvHD - high disease free survival

12 Cellular Characteristics BM PB UCB Volume collected ml ml ml Median CD34 content (x 10 6 /kg*) Median T cells content (x 10 6 /kg*) Target cell dose > 2 x 10 8 (TNC /kg*) 5-10 x 10 6 (CD34+ /kg*) > 0.3 x 10 8 (TNC /kg*) * of recipient body weight BM: high volume PB: higher CD34 and T cells content UCB: lower CD34 but highly proliferative, lower and immature T cells

13 Clinical Characteristics BM PB UCB HLA matching Restrictive Restrictive Engraftment Faster than CB but slower than PB Fastest Less restrictive (>tolerance) Slowest Acute GvHD ++ ++/+++ + Chronic GvHD Graft vs Tumor effect Availability Donor s Risk ++ ++/ Depends on donor type Anesthesia Surgical Procedure Depends on donor type Use of GF Apheresis Immediate access (CB banks) None

14 PB vs BM Several studies have been conducted in the main HSCT settings: > cgvhd > Graft vs Tumor effect May improve outcomes in pts with unfavorable malignancies PB early immunohematologic reconstitution May improve outcomes in pts with > risk of infections or graft failure No OS advantage/consistent results for any of the major outcomes except in non malignant disorders (aplastic anemia:> GvHD, < survival) The optimal product has yet to be determined, standardized indications are not available BM and PB are acceptable HSC sources Many factors involved in the choice patient, disease and transplant-related, donor-related (personal choice, controindication to anesthesia), centre preference and logistics

15 Donor choice HLA matched sibling (BM/PB) = first choice 25% pts Alternatives HLA-MM or Haploidentical related PB/BM HLA-M/MM adult unrelated (donor registries) PB/BM Related/unrelated HLA-M/MM UCB (CB banks) Relative merits of unrelated adult donors vs UCB vs haplo remains to be determined Most centres prefer the use of adult unrelated donors over the other alternative HSCs sources

16 Adult unrelated donor >21 millions; difficult to find a donor for pts from certain ethnic and racial backgrounds Critical issue = HLA matching Donor choice based on HR allelic typing at 10 HLA loci improved outcomes Acceptable donors limited to 1 HLA MM Similar results to HLA-M sibling HLA MM > GvHD in malignancies and > graft failure in non malignant disorders Each HLA MM may reduce the probability of 5y OS by ~ 10% 3-6 months to complete a search for a MUD Feasible only for diseases with suitable clinical courses if search initiated early in the course of disease treatment

17 UCBT Pros CB banks: ~600,000 units, immediate availability, no donor risk, advantage for ethnic minorities, low risk of transmissible infections Applicability for children and adults with malignant and non malignant disorders Survival outcomes comparable to other sources of HSCs HLA mismatch accepted; GvHD and relapse (> GvL) Use extended in older populations with RIC and double UCBT Cons Delayed engraftment and immune reconstitution; high risk of graft failure (> TRM) Unavailability of the donor for additional donations (i.e DLI) Sustainability of CB banks (cost) Critical issue in UCB unit selection: CELL DOSE - TNC dose 2.5x10 7 /kg ( 4 in non malignant) MM better than 2, avoid 3-4 MM - higher cell dose allows > HLA mismatches

18 Haploidentical related donor Only an haplotype is shared between the donor and the recipient Critical issue = high risk of graft failure and GvHD T cell depletion or enhanced GvHD prophylaxis delayed immune reconstitution ( risk of infections and relapse) Both BM (primed with GF or not) and PB used potential risk for the donor Immediate availability; virtually everyone has at least an haploidentical donor Applicable to children and adults with malignant and non malignant disorders Early results comparable to other HSCs sources Few publications on long term results

19 Algorithm of donor search Patient and family HLA typing HLA matched sibling NO HLA matched sibling 1st choice HSCT Search simultaneously for unrelated donor in BMDW registries and CB Banks HLA 9/10 matched unrelated donor Unrelated CBU HLA 4-6/6 matched 2,5x10 7 TNC/kg Related haploidentical donor Consider: indication of the HSCT, pts and donor features (CMV, ABO, age, donor sex) If urgent HSCT needed prefer CB or related haploidentical donor Expertise of the centre is very important If low cell dose in a single unit UCB, consider a double UCBT

20 Conclusion Multiple factors involved in the donor and HSCs source choice Patient s & Disease s features Donor s safety & features Centre Clinical Approach & Expertise Transplant setting The wide choice of donor sources has extended the possibility of offering HSCT to almost all patients who need this procedure

21 Thank you for the attention!

22 EUROCORD TEAM 2013 Annalisa Ruggeri, MD Vanderson Rocha, MD PhD Scientific Director Agnès Devergie, MD Eliane Gluckman, MD FRCP Project Leader Federica Giannotti, MD Chantal Kenzey Data Manager Fernanda Volt, MT Myriam Pruvost, PA Erick Xavier, MD

23 Clinical Case 1 Male; 12y; diagnosis of severe aplastic anemia First line treatment HSCT from an HLA identical sibling NO SIBLINGS Immunosuppressive treatment (ATG+CSA) + search for unrelated donor initiated on registries: WBMR, UCB Banks After 6 months no response to therapy and several donors identified: - adult unrelated donor 8/10 matched - 6/6 HLA matched UCB with a TNC dose of 5.5x10 7 /Kg - haploidentical mother eligible for donation UCBT vs Haplo UCBT compared to Haplo = lower rates of GvHD and graft rejection in non malignant disorders Complete donor chimerism, no GvHD, after 2y FU pt alive in good health

24 Clinical Case 2 Male; 52y; CMV seropositive; diagnosis of high risk AML in CR1 First line treatment HSCT from an HLA identical sibling 1 SIBLING NOT ELIGIBLE (treated 2y ago for melanoma) Search for unrelated donor initiated on registries has identified: - adult unrelated donor: male, 38 years old, CMV seropositive, HLA-matched at A, B, C, DRB1 and DPB1 (10/10), ABO blood group matched to the recipient, available for donation in 4 weeks, chose to donate PBSC (even if the centre asked for BM) - two cord blood units: one 6/6 matched with TNC 1.5 x 10 7 /kg and the other 4/6 matched with TNC 2.4 x 10 7 /kg (sum: 3.9 x 10 7 /kg) The pt has an haploidentical son eligible for donation MUD is the choice Complete donor chimerism, agvhd grade II (skin) responsive to steroids, after 2y FU pt alive in CR without cgvhd

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