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Article ; Online: Heterogeneity in Studies of Mesenchymal Stromal Cells to Treat or Prevent Graft-versus-Host Disease: A Scoping Review of the Evidence.

Rizk, Mina / Monaghan, Madeline / Shorr, Risa / Kekre, Natasha / Bredeson, Christopher N / Allan, David S

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation

2016 Volume 22, Issue 8, Page(s) 1416–1423

Abstract: Effective treatments are lacking for the treatment of steroid-refractory graft-versus-host disease (GVHD), a major cause of morbidity and mortality after allogeneic hematopoietic cell transplantation. Mesenchymal stromal cells (MSCs) have demonstrated ... ...

Abstract	Effective treatments are lacking for the treatment of steroid-refractory graft-versus-host disease (GVHD), a major cause of morbidity and mortality after allogeneic hematopoietic cell transplantation. Mesenchymal stromal cells (MSCs) have demonstrated promise but there is uncertainty regarding their clinical effectiveness. A systematic scoping review of the literature was performed to characterize the heterogeneity of published studies and identify opportunities for standardization. Thirty studies were identified, including 19 studies (507 patients) addressing the treatment of acute or chronic GVHD and 11 prevention studies (277 patients). Significant heterogeneity was observed in the age and diagnoses of study subjects, intensity and specifics of the conditioning regimens, degree of HLA matching, and source of hematopoietic cells. MSCs were derived from bone marrow (83% of studies), cord blood (13%), or adipose tissue (3%) and were cryopreserved from third-party allogeneic donors in the majority of studies (91% of prevention studies and 63% of treatment studies). Culture conditions and media supplements were highly variable and characterization of MSCs did not conform to all International Society for Cellular Therapy criteria in any study. MSCs were harvested from cell culture at passage 1 to 7 and the dosage of MSCs ranged from 0.3 to 10 × 10(6)/kg, using varying schedules of administration. Treatment response criteria were not standardized and effectiveness in controlled treatment studies (5 studies) was unconvincing. Details of actively recruiting trials suggest heterogeneity still persists with only 53% of registered trials describing the use of standard GVHD response criteria and few detailing methods of MSC manufacturing. Future studies will need to make substantial coordinated efforts to reduce study heterogeneity and clarify the role of MSCs in GVHD.
Language	English
Publishing date	2016-08
Publishing country	United States
Document type	Journal Article
ZDB-ID	1474865-4
ISSN	1523-6536 ; 1083-8791
ISSN (online)	1523-6536
ISSN	1083-8791
DOI	10.1016/j.bbmt.2016.04.010
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Article ; Online: Current trends in clinical studies of allogeneic hematopoietic stem cell transplantation.

Pilon, Sophie / Jedrysiak, Daniel / Sheppard, Dawn / Bredeson, Christopher N / Tay, Jason / Allan, David S

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation

2015 Volume 21, Issue 2, Page(s) 364–370

Abstract: Allogeneic hematopoietic stem cell transplantation (HSCT) is a specialized intervention performed at select centers worldwide. The extent to which specific aspects of care in allogeneic HSCT have been studied and the types of studies performed for ... ...

Abstract	Allogeneic hematopoietic stem cell transplantation (HSCT) is a specialized intervention performed at select centers worldwide. The extent to which specific aspects of care in allogeneic HSCT have been studied and the types of studies performed for different aspects of care remains incompletely documented. Studies in allogeneic HSCT were systematically identified from selected high-profile transplant journals between July 2010 and June 2011 and previously reported in a study addressing the definition of clinical outcomes in HSCT. All articles were retrieved and assessed for study characteristics and categorized by specific aspects of care related to allogeneic HSCT. One hundred sixteen articles were retrieved and reviewed in detail by 2 investigators. The most studied aspect of care was conditioning regimens. Transfusion practices were the most understudied aspect of care. Interestingly, most studies included both adult and pediatric patients. Studies involving all hematological malignancies were encountered more often than disease-specific studies. Geographically, most patients described in the published reports were treated only in North America or only in Europe. Most studies were retrospective (78), and 25 reported on multicenter registry data. Of the 38 prospective studies, 8 were randomized controlled trials (RCTs) and predominantly focused on prevention and treatment of graft-versus-host disease (GVHD) and infections. Median follow-up was longer in retrospective registry studies (54 months) and shortest in RCTs (32 months). The proportion of positive outcomes in retrospective and prospective studies was remarkably high (>80% for all categories) and not significantly different across all aspects of care (P > .05). When comparing RCTs and registry data studies, this proportion was similar and high (95% and 100%, respectively, P > .05). Our study highlights the established and important role of retrospective registry studies for many aspects of care and suggests RCTs may be most relevant for studies on infectious complications and GVHD.
MeSH term(s)	Adult ; Child ; Cohort Studies ; Female ; Graft vs Host Disease/immunology ; Graft vs Host Disease/mortality ; Graft vs Host Disease/pathology ; Graft vs Host Disease/prevention & control ; Hematologic Neoplasms/immunology ; Hematologic Neoplasms/mortality ; Hematologic Neoplasms/pathology ; Hematologic Neoplasms/therapy ; Hematopoietic Stem Cell Transplantation/trends ; Humans ; Male ; Myeloablative Agonists/therapeutic use ; Opportunistic Infections/immunology ; Opportunistic Infections/mortality ; Opportunistic Infections/pathology ; Opportunistic Infections/prevention & control ; Randomized Controlled Trials as Topic ; Survival Analysis ; Transplantation Conditioning/methods ; Transplantation, Homologous ; Treatment Outcome
Chemical Substances	Myeloablative Agonists
Language	English
Publishing date	2015-02
Publishing country	United States
Document type	Journal Article ; Meta-Analysis ; Research Support, Non-U.S. Gov't
ZDB-ID	1474865-4
ISSN	1523-6536 ; 1083-8791
ISSN (online)	1523-6536
ISSN	1083-8791
DOI	10.1016/j.bbmt.2014.09.014
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Article: Considerations when designing a clinical trial of haematopoietic stem cell transplantation for autoimmune disease.

Bredeson, Christopher N / Pavletic, Steven Z

Best practice & research. Clinical haematology

2004 Volume 17, Issue 2, Page(s) 327–343

Abstract: The design and conduct of clinical trials of haematopoietic stem cell transplantation (HSCT) for autoimmune diseases requires investigators to address issues unique to this therapeutic approach and patient population. The proper composition of the ... ...

Abstract	The design and conduct of clinical trials of haematopoietic stem cell transplantation (HSCT) for autoimmune diseases requires investigators to address issues unique to this therapeutic approach and patient population. The proper composition of the protocol team is central to success. It is important to recognize that transplant physicians are no longer also the disease experts when transplanting patients with autoimmune diseases, and a close collaborative relationship between these groups early in the design stage must continue through the care of patients on trial to the assessment of toxicity and response. The early involvement of statisticians expert in clinical trial design and patient representatives are also vital to developing the optimal protocol. Each step in design and implementation requires particular consideration of the unique aspects of applying HSCT to autoimmune diseases. Some areas discussed are the role of disease and transplant databases in designing and analysing clinical trials, design options for early-phase trials, maintaining clinical equipoise, eligibility criteria, blinding, outcome measures and statistical analysis, and the composition and role of the data safety and monitoring boards. Although no blueprint for designing and conducting a trial of HSCT for autoimmune diseases can be laid out, the process should take into consideration the issues highlighted herein.
MeSH term(s)	Autoimmune Diseases/therapy ; Clinical Trials as Topic/methods ; Humans ; Patient Selection ; Research Design ; Stem Cell Transplantation ; Treatment Outcome
Language	English
Publishing date	2004-06
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	2048027-1
ISSN	1532-1924 ; 1521-6926
ISSN (online)	1532-1924
ISSN	1521-6926
DOI	10.1016/j.beha.2004.04.007
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Article ; Online: Intermittent zoledronic Acid prevents bone loss in adults after allogeneic hematopoietic cell transplantation.

Hari, Parameswaran / DeFor, Todd E / Vesole, David H / Bredeson, Christopher N / Burns, Linda J

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation

2013 Volume 19, Issue 9, Page(s) 1361–1367

Abstract: Bone mineral density (BMD) loss is common in survivors of allogeneic hematopoietic cell transplantation (alloHCT). We performed a multicenter, phase II, randomized open-label trial of intravenous zoledronic acid (ZA) to prevent BMD loss in adult ... ...

Abstract	Bone mineral density (BMD) loss is common in survivors of allogeneic hematopoietic cell transplantation (alloHCT). We performed a multicenter, phase II, randomized open-label trial of intravenous zoledronic acid (ZA) to prevent BMD loss in adult recipients of alloHCT with osteopenia before HCT. The treatment group received ZA 4 mg intravenously within 28 days pre-HCT and at 3 and 6 months after HCT. Both treatment and control groups received calcium carbonate and vitamin D supplements. Of 61 patients, 32 were randomized to the ZA cohort and 29 to the control cohorts. More patients in the ZA group had an HCT comorbidity index high-risk score of ≥3 (50% versus 21%, P < .01). Baseline BMD, T-scores, serum osteocalcin, bone alkaline phosphatase, and urine N-telopeptide (UNTX) levels were similar in both cohorts. Thirty patients were evaluable for outcomes (11 from the treatment and 19 from the control group). At 12 months, subjects in the treatment group had an improvement in BMD at the femoral neck (mean change, .018 for ZA group versus -.054 for controls; P = .04) and a significant decline in levels of UNTX (-56 for ZA group versus -9 for control; P = .04) compared with baseline. ZA was well tolerated and not associated with any cases of osteonecrosis of jaw or renal impairment. Lower survival observed in the ZA cohort was likely related to baseline imbalance in HCT-CI scores. Intermittent ZA is effective in preserving long-term bone health in adult alloHCT recipients at risk for osteoporosis.
MeSH term(s)	Adult ; Aged ; Bone Density/drug effects ; Bone Density Conservation Agents/administration & dosage ; Bone Resorption/prevention & control ; Diphosphonates/administration & dosage ; Female ; Hematopoietic Stem Cell Transplantation/adverse effects ; Hematopoietic Stem Cell Transplantation/methods ; Humans ; Imidazoles/administration & dosage ; Male ; Middle Aged ; Transplantation, Homologous ; Treatment Outcome ; Young Adult
Chemical Substances	Bone Density Conservation Agents ; Diphosphonates ; Imidazoles ; zoledronic acid (6XC1PAD3KF)
Language	English
Publishing date	2013-09
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	1474865-4
ISSN	1523-6536 ; 1083-8791
ISSN (online)	1523-6536
ISSN	1083-8791
DOI	10.1016/j.bbmt.2013.06.015
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Article ; Online: Alternative donor transplantation for myelodysplastic syndromes: haploidentical relative and matched unrelated donors.

Blood advances

2021 Volume 5, Issue 4, Page(s) 975–983

Abstract: We compared outcomes in 603 patients with myelodysplastic syndrome (MDS) after HLA-haploidentical relative (n = 176) and HLA-matched unrelated (n = 427) donor hematopoietic cell transplantation (HCT) from 2012 to 2017, using the Center for International ... ...

Abstract	We compared outcomes in 603 patients with myelodysplastic syndrome (MDS) after HLA-haploidentical relative (n = 176) and HLA-matched unrelated (n = 427) donor hematopoietic cell transplantation (HCT) from 2012 to 2017, using the Center for International Blood and Marrow Transplant Research database. All transplantations used reduced-intensity conditioning regimens. Total-body irradiation plus cyclophosphamide and fludarabine was the predominant regimen for HLA-haploidentical relative donor HCT, and graft-versus-host disease (GVHD) prophylaxis was uniformly posttransplantation cyclophosphamide, calcineurin inhibitor, and mycophenolate. Fludarabine with busulfan or melphalan was the predominant regimen for HLA-matched unrelated donor HCT, and GVHD prophylaxis was calcineurin inhibitor with mycophenolate or methotrexate. Results of multivariate analysis revealed higher relapse (hazard ratio [HR], 1.56; P = .0055; 2-year relapse rate, 48% vs 33%) and lower disease-free survival (DFS) rates after HLA-haploidentical relative donor HCT (HR, 1.29; P = .042; 2-year DFS, 29% vs 36%). However, overall survival (OS) rates did not differ between donor type (HR, 0.94; P = .65; 2-year OS, 46% for HLA-haploidentical and 44% for HLA-matched unrelated donor HCT) because of mortality associated with chronic GVHD. Acute grade 2 to 4 GVHD (HR, 0.44; P < .0001) and chronic GVHD (HR, 0.36; P < .0001) were lower after HLA-haploidentical relative donor HCT. By 2 years, probability of death resulting from chronic GVHD was lower after HLA-haploidentical relative compared with HLA-matched unrelated donor HCT (6% vs 21%), negating any potential survival advantage from better relapse control. Both donor types extend access to transplantation for patients with MDS; strategies for better relapse control are desirable for HLA-haploidentical relative donor HCT, and effective GVHD prophylaxis regimens are needed for unrelated donor HCT.
MeSH term(s)	Graft vs Host Disease ; Histocompatibility Testing ; Humans ; Myelodysplastic Syndromes/therapy ; Transplantation Conditioning ; Unrelated Donors
Language	English
Publishing date	2021-02-12
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	2915908-8
ISSN	2473-9537 ; 2473-9529
ISSN (online)	2473-9537
ISSN	2473-9529
DOI	10.1182/bloodadvances.2020003654
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Article ; Online: Payment and Care for Hematopoietic Cell Transplantation Patients: Toward a Specialized Medical Home for Complex Care Patients.

Gajewski, James L / McClellan, Mark B / Majhail, Navneet S / Hari, Parameswaran N / Bredeson, Christopher N / Maziarz, Richard T / LeMaistre, Charles F / Lill, Michael C / Farnia, Stephanie H / Komanduri, Krishna V / Boo, Michael J

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation

2017 Volume 24, Issue 1, Page(s) 4–12

Abstract: Patient-centered medical home models are fundamental to the advanced alternative payment models defined in the Medicare Access and Children's Health Insurance Plan Reauthorization Act (MACRA). The patient-centered medical home is a model of healthcare ... ...

Abstract	Patient-centered medical home models are fundamental to the advanced alternative payment models defined in the Medicare Access and Children's Health Insurance Plan Reauthorization Act (MACRA). The patient-centered medical home is a model of healthcare delivery supported by alternative payment mechanisms and designed to promote coordinated medical care that is simultaneously patient-centric and population-oriented. This transformative care model requires shifting reimbursement to include a per-patient payment intended to cover services not previously reimbursed such as disease management over time. Payment is linked to quality measures, including proportion of care delivered according to predefined pathways and demonstrated impact on outcomes. Some medical homes also include opportunities for shared savings by reducing overall costs of care. Recent proposals have suggested expanding the medical home model to specialized populations with complex needs because primary care teams may not have the facilities or the requisite expertise for their unique needs. An example of a successful care model that may provide valuable lessons for those creating specialty medical home models already exists in many hematopoietic cell transplantation (HCT) centers that deliver multidisciplinary, coordinated, and highly specialized care. The integration of care delivery in HCT centers has been driven by the specialty care their patients require and by the payment methodology preferred by the commercial payers, which has included bundling of both inpatient and outpatient care in the peritransplant interval. Commercial payers identify qualified HCT centers based on accreditation status and comparative performance, enabled in part by center-level comparative performance data available within a national outcomes database mandated by the Stem Cell Therapeutic and Research Act of 2005. Standardization across centers has been facilitated via voluntary accreditation implemented by Foundation for the Accreditation of Cell Therapy. Payers have built on these community-established programs and use public outcomes and program accreditation as standards necessary for inclusion in specialty care networks and contracts. Although HCT centers have not been described as medical homes, most HCT providers have already developed the structures that address critical requirements of MACRA for medical homes.
MeSH term(s)	Delivery of Health Care/economics ; Delivery of Health Care/methods ; Hematopoietic Stem Cell Transplantation/economics ; Humans ; Patient Care Management/economics ; Patient Care Management/trends ; Patient Care Team/trends ; Quality of Health Care/standards ; Reimbursement, Incentive/economics
Language	English
Publishing date	2017-09-28
Publishing country	United States
Document type	Journal Article
ZDB-ID	1474865-4
ISSN	1523-6536 ; 1083-8791
ISSN (online)	1523-6536
ISSN	1083-8791
DOI	10.1016/j.bbmt.2017.09.012
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Article ; Online: HLA-haploidentical vs matched unrelated donor transplants with posttransplant cyclophosphamide-based prophylaxis.

Gooptu, Mahasweta / Romee, Rizwan / St Martin, Andrew / Arora, Mukta / Al Malki, Monzr / Antin, Joseph H / Bredeson, Christopher N / Brunstein, Claudio G / Chhabra, Saurabh / Fuchs, Ephraim J / Ghosh, Nilanjan / Grunwald, Michael R / Kanakry, Christopher G / Kekre, Natasha / McGuirk, Jospeh P / McNiece, Ian K / Mehta, Rohtesh S / Mielcarek, Marco / Milano, Fillipo /

Modi, Dipenkumar / Reshef, Ran / Solomon, Scott R / Schroeder, Mark A / Waller, Edmund K / Inamoto, Yoshiro / Soiffer, Robert J / Eapen, Mary

Blood

2021 Volume 138, Issue 3, Page(s) 273–282

Abstract: Posttransplant cyclophosphamide (PTCy) graft-versus-host disease (GVHD) prophylaxis has enabled haploidentical (Haplo) transplantation to be performed with results similar to those after matched unrelated donor (MUD) transplantation with traditional ... ...

Abstract	Posttransplant cyclophosphamide (PTCy) graft-versus-host disease (GVHD) prophylaxis has enabled haploidentical (Haplo) transplantation to be performed with results similar to those after matched unrelated donor (MUD) transplantation with traditional prophylaxis. The relative value of transplantation with MUD vs Haplo donors when both groups receive PTCy/calcineurin inhibitor/mycophenolate GVHD prophylaxis is not known. We compared outcomes after 2036 Haplo and 284 MUD transplantations with PTCy GVHD prophylaxis for acute leukemia or myelodysplastic syndrome in adults from 2011 through 2018. Cox regression models were built to compare outcomes between donor types. Recipients of myeloablative and reduced-intensity regimens were analyzed separately. Among recipients of reduced-intensity regimens, 2-year graft failure (3% vs 11%), acute grades 2 to 4 GVHD (hazards ratio [HR], 0.70; P = .022), acute grades 3 and 4 GVHD (HR, 0.41; P = .016), and nonrelapse mortality (HR, 0.43; P = .0008) were lower after MUD than with Haplo donor transplantation. Consequently, disease-free (HR, 0.74; P = .008; 55% vs 41%) and overall (HR, 0.65; P = .001; 67% vs 54%) survival were higher with MUD than with Haplo transplants. Among recipients of myeloablative regimens, day-100 platelet recovery (95% vs 88%) was higher and grades 3 and 4 acute (HR, 0.39; P = .07) and chronic GVHD (HR, 0.66; P = .05) were lower after MUD than with Haplo donor transplantation. There were no differences in graft failure, relapse, nonrelapse mortality, and disease-free and overall survival between donor types with myeloablative conditioning regimens. These data extend and confirm the importance of donor-recipient HLA matching for allogeneic transplantation. A MUD is the preferred donor, especially for transplantations with reduced-intensity conditioning regimens.
MeSH term(s)	Adult ; Cyclophosphamide/therapeutic use ; Female ; Graft vs Host Disease/prevention & control ; Hematopoietic Stem Cell Transplantation/methods ; Humans ; Immunosuppressive Agents/therapeutic use ; Leukemia, Myeloid, Acute/therapy ; Male ; Middle Aged ; Myelodysplastic Syndromes/therapy ; Transplantation Conditioning ; Transplantation, Haploidentical/methods ; Transplantation, Homologous/methods ; Treatment Outcome ; Unrelated Donors
Chemical Substances	Immunosuppressive Agents ; Cyclophosphamide (8N3DW7272P)
Language	English
Publishing date	2021-07-20
Publishing country	United States
Document type	Comparative Study ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	80069-7
ISSN	1528-0020 ; 0006-4971
ISSN (online)	1528-0020
ISSN	0006-4971
DOI	10.1182/blood.2021011281
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Article: Subcutaneous plasmacytomas with tropism to sites of previous trauma in a multiple myeloma patient treated with an autologous bone marrow transplant.

Rosenblum, Michael D / Bredeson, Christopher N / Chang, Chung-Che / Rizzo, J Douglas

American journal of hematology

2003 Volume 72, Issue 4, Page(s) 274–277

Abstract: We report the case of a 59-year-old woman with Durie-Salmon stage IIIB IgGkappa multiple myeloma (MM), who presented 83 days after autologous hematopoietic stem cell transplant (HSCT) with multiple subcutaneous plasmacytomas. These lesions were confined ... ...

Abstract	We report the case of a 59-year-old woman with Durie-Salmon stage IIIB IgGkappa multiple myeloma (MM), who presented 83 days after autologous hematopoietic stem cell transplant (HSCT) with multiple subcutaneous plasmacytomas. These lesions were confined exclusively to sites where the patient had sustained local trauma. The patient had no pre-transplant history of extramedullary disease and no evidence of plasma cells in the peripheral blood at any time throughout the course of her disease. This case represents the first report of refractory MM presenting as multiple subcutaneous plasmacytomas with specific tropism to sites of previous trauma. Selection of tumor cell subclones with unique chemokine receptor expression profiles that may explain this clinical observation is discussed.
MeSH term(s)	Bone Marrow Transplantation ; Catheterization, Central Venous/adverse effects ; Cell Movement ; Chemokines/physiology ; Fatal Outcome ; Female ; Head and Neck Neoplasms/secondary ; Humans ; Injections, Intravenous/adverse effects ; Injections, Subcutaneous/adverse effects ; Middle Aged ; Multiple Myeloma/pathology ; Multiple Myeloma/secondary ; Multiple Myeloma/therapy ; Neoplastic Stem Cells/pathology ; Organ Specificity ; Phlebotomy/adverse effects ; Recurrence ; Skin/injuries ; Skin Neoplasms/secondary ; Transplantation, Autologous
Chemical Substances	Chemokines
Language	English
Publishing date	2003-04
Publishing country	United States
Document type	Case Reports ; Journal Article
ZDB-ID	196767-8
ISSN	1096-8652 ; 0361-8609
ISSN (online)	1096-8652
ISSN	0361-8609
DOI	10.1002/ajh.10296
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Article: High-dose therapy and autologous hematopoietic stem cell transplantation for patients with primary systemic amyloidosis: a Center for International Blood and Marrow Transplant Research Study.

Vesole, David H / Pérez, Waleska S / Akasheh, Marwan / Boudreau, Christian / Reece, Donna E / Bredeson, Christopher N

Mayo Clinic proceedings

2006 Volume 81, Issue 7, Page(s) 880–888

Abstract: Objective: To determine the outcome of high-dose therapy with autologous hematopoietic stem cell transplantation (HSCT) in patients with primary systemic amyloidosis reported to the Center for International Blood and Marrow Transplant Research (CIBMTR).! ...

Abstract	Objective: To determine the outcome of high-dose therapy with autologous hematopoietic stem cell transplantation (HSCT) in patients with primary systemic amyloidosis reported to the Center for International Blood and Marrow Transplant Research (CIBMTR). Patients and methods: A total of 107 recipients of autologous HSCT for amyloidosis from 48 transplantation centers were reported to the CIBMTR between 1995 and 2001. Hematologic and organ responses were assessed at 100 days and 1 year. Transplantation-related mortality (TRM) was assessed at day 30 after HSCT. A multivariate analysis assessed factors that influenced overall survival. Results: Improvement at day 100 was seen in 1 or more amyloidosis-affected sites (bone marrow, kidney, liver, and/or heart) in 28 (36%) of 77 patients; the 1-year responses included complete response (16%), partial response (16%), stable disease (31%), and disease progression (10%). With a median follow-up of 30 months, the 1- and 3-year survival rates were 66% (95% confidence interval [CI], 56%-75%) and 56% (95% CI, 45%-66%), respectively. The day 30 TRM was 18% (95% CI, 11%-26%). In the multivariate analysis, only the year of transplantation (patients who most recently underwent transplantation) was associated with post-HSCT survival (P-.02). Conclusion: In this multi-institutional CIBMTR study, the 3-year survival rate was comparable to single-center results, with patients who more recently underwent transplantation faring better. Of note, the TRM was higher than that reported by single centers, which may reflect differences in patient selection and/or experience in treating this challenging disease. We hope that a better understanding of the recently recognized prognostic factors and more stringent patient selection will result in lower TRM and improved survival.
MeSH term(s)	Adult ; Aged ; Amyloidosis/mortality ; Amyloidosis/pathology ; Amyloidosis/therapy ; Antineoplastic Agents, Alkylating/administration & dosage ; Antineoplastic Agents, Alkylating/therapeutic use ; Dose-Response Relationship, Drug ; Female ; Follow-Up Studies ; Hematopoietic Stem Cell Transplantation/methods ; Humans ; International Cooperation ; Kidney/pathology ; Liver/pathology ; Male ; Melphalan/administration & dosage ; Melphalan/therapeutic use ; Middle Aged ; Myocardium/pathology ; Retrospective Studies ; Survival Rate/trends ; Transplantation, Autologous ; Treatment Outcome
Chemical Substances	Antineoplastic Agents, Alkylating ; Melphalan (Q41OR9510P)
Language	English
Publishing date	2006-07
Publishing country	England
Document type	Clinical Trial ; Comparative Study ; Journal Article ; Multicenter Study ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	124027-4
ISSN	1942-5546 ; 0025-6196
ISSN (online)	1942-5546
ISSN	0025-6196
DOI	10.4065/81.7.880
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Article ; Online: Indications for Autologous and Allogeneic Hematopoietic Cell Transplantation: Guidelines from the American Society for Blood and Marrow Transplantation.

Majhail, Navneet S / Farnia, Stephanie H / Carpenter, Paul A / Champlin, Richard E / Crawford, Stephen / Marks, David I / Omel, James L / Orchard, Paul J / Palmer, Jeanne / Saber, Wael / Savani, Bipin N / Veys, Paul A / Bredeson, Christopher N / Giralt, Sergio A / LeMaistre, Charles F

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation

2015 Volume 21, Issue 11, Page(s) 1863–1869

Abstract: Approximately 20,000 hematopoietic cell transplantation (HCT) procedures are performed in the United States annually. With advances in transplantation technology and supportive care practices, HCT has become safer, and patient survival continues to ... ...

Abstract	Approximately 20,000 hematopoietic cell transplantation (HCT) procedures are performed in the United States annually. With advances in transplantation technology and supportive care practices, HCT has become safer, and patient survival continues to improve over time. Indications for HCT continue to evolve as research refines the role for HCT in established indications and identifies emerging indications where HCT may be beneficial. The American Society for Blood and Marrow Transplantation (ASBMT) established a multiple-stakeholder task force consisting of transplant experts, payer representatives, and a patient advocate to provide guidance on "routine" indications for HCT. This white paper presents the recommendations from the task force. Indications for HCT were categorized as follows: (1) Standard of care, where indication for HCT is well defined and supported by evidence; (2) Standard of care, clinical evidence available, where large clinical trials and observational studies are not available but HCT has been shown to be effective therapy; (3) Standard of care, rare indication, for rare diseases where HCT has demonstrated effectiveness but large clinical trials and observational studies are not feasible; (4) Developmental, for diseases where preclinical and/or early phase clinical studies show HCT to be a promising treatment option; and (5) Not generally recommended, where available evidence does not support the routine use of HCT. The ASBMT will periodically review these guidelines and will update them as new evidence becomes available.
MeSH term(s)	Adult ; Age Factors ; Bone Marrow Transplantation ; Child ; Clinical Trials as Topic ; Hematologic Neoplasms/pathology ; Hematologic Neoplasms/therapy ; Hematopoietic Stem Cell Transplantation ; Humans ; Rare Diseases/pathology ; Rare Diseases/therapy ; Societies, Medical ; Standard of Care ; Transplantation, Autologous ; Transplantation, Homologous ; United States
Language	English
Publishing date	2015-11
Publishing country	United States
Document type	Guideline ; Journal Article
ZDB-ID	1474865-4
ISSN	1523-6536 ; 1083-8791
ISSN (online)	1523-6536
ISSN	1083-8791
DOI	10.1016/j.bbmt.2015.07.032
Database	MEDical Literature Analysis and Retrieval System OnLINE

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