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Article ; Online: Annexin A2 Loss After Cardiopulmonary Bypass and Development of Acute Postoperative Respiratory Dysfunction in Children.

Hsing, Deyin D / Stock, Arabela C / Greenwald, Bruce M / Bacha, Emile A / Flynn, Patrick A / Carroll, Sheila J / Dayton, Jeffrey D / Prockop, Susan E / Qiu, Yuqing / Almeida, Dena / Tamura, Shoran / Hajjar, Katherine A

Critical care explorations

2023 Volume 5, Issue 2, Page(s) e0862

Abstract: The primary objective of this study was to determine whether expression of the multifunctional and adherens junction-regulating protein, annexin A2 (A2), is altered following cardiopulmonary bypass (CPB). A secondary objective was to determine whether ... ...

Abstract	The primary objective of this study was to determine whether expression of the multifunctional and adherens junction-regulating protein, annexin A2 (A2), is altered following cardiopulmonary bypass (CPB). A secondary objective was to determine whether depletion of A2 is associated with post-CPB organ dysfunction in children. Design: In a prospective, observational study conducted over a 1-year period in children undergoing cardiac surgery requiring CPB, we analyzed A2 expression in peripheral blood mononuclear cells at different time points. We then assessed the relationship of A2 expression with organ function at each time point in the early postoperative period. Setting: Twenty-three-bed mixed PICU in a tertiary academic center. Participants: Patients 1 month to 18 years old undergoing cardiac surgery requiring CPB. Mean outcome measurements and results: We analyzed A2 expression in 22 enrolled subjects ( Conclusions and relevance: The degree of depletion of A2 following CPB correlates with more severe organ dysfunction, especially acute respiratory compromise in children under 2 years. These findings suggest that loss of A2 may contribute to pulmonary microvascular leak in young children following CPB.
Language	English
Publishing date	2023-02-10
Publishing country	United States
Document type	Journal Article
ISSN	2639-8028
ISSN (online)	2639-8028
DOI	10.1097/CCE.0000000000000862
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Article ; Online: Tabelecleucel for EBV+ PTLD following allogeneic HCT or SOT in a multicenter expanded access protocol.

Blood advances

2024

Abstract: Patients with Epstein-Barr virus (EBV)-positive post-transplant lymphoproliferative disease (EBV+ PTLD) in whom initial treatment fails have few options and historically low median overall survival (OS) of 0.7 months following allogeneic hematopoietic ... ...

Abstract	Patients with Epstein-Barr virus (EBV)-positive post-transplant lymphoproliferative disease (EBV+ PTLD) in whom initial treatment fails have few options and historically low median overall survival (OS) of 0.7 months following allogeneic hematopoietic cell transplant (HCT) and 4.1 months following solid organ transplant (SOT). Tabelecleucel is an off-the-shelf, allogeneic EBV-specific cytotoxic T-lymphocyte immunotherapy for EBV+ PTLD. Previous single-center experience showed responses in patients with EBV+ PTLD following HCT or SOT. We now report outcomes from a multicenter expanded access protocol (NCT02822495) in HCT (n = 14) and SOT (n = 12) recipients treated with tabelecleucel for EBV+ PTLD that was relapsed/refractory to rituximab ± chemotherapy. The investigator-assessed objective response rate was 65.4% overall (including 38.5% with a complete and 26.9% with a partial response), 50.0% in HCT, and 83.3% in SOT. The estimated 1- and 2-year OS rates (95% CI) were both 70.0% (46.5, 84.7) overall, both 61.5% (30.8, 81.8) in HCT, and both 81.5% (43.5, 95.1) in SOT (median follow-up: 8.2, 2.8, and 22.5 months, respectively). Patients responding to tabelecleucel had higher 1- and 2-year OS rates (94.1%) than non-responders (0%). Treatment was well tolerated with no reports of tumor flare, cytokine release syndrome, or rejection of marrow and SOT. Results demonstrate clinically meaningful outcomes across a broad population treated with tabelecleucel, indicating a potentially transformative and accessible treatment advance for relapsed/refractory EBV+ PTLD following HCT or SOT.
Language	English
Publishing date	2024-04-16
Publishing country	United States
Document type	Journal Article
ZDB-ID	2915908-8
ISSN	2473-9537 ; 2473-9529
ISSN (online)	2473-9537
ISSN	2473-9529
DOI	10.1182/bloodadvances.2023011626
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Zs.A 7153: Show issues

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Article ; Online: Part 5: Allogeneic HSCT in refractory SJIA with lung disease; recent cases from centers in North America & Europe.

Grom, Alexei A / Canna, Scott W / Abu-Arja, Rolla F / Sinha, Rashmi / Peixoto, Luciana / Cannizzaro, Elvira / Chandrakasan, Shanmuganathan / Driest, Kyla / Marsh, Rebecca / Neven, Bénédicte / Onel, Karen / Prahalad, Sampath / Prockop, Susan / Quartier, Pierre / Roth, Johannes / Schulert, Grant / Silva, Juliana M F / Wall, Donna / Zeilhofer, Ulrike

Pediatric rheumatology online journal

2024 Volume 21, Issue Suppl 1, Page(s) 86

Abstract: It has been increasingly recognized that there is a subset of patients with refractory systemic JIA, who have failed all available medications and may benefit from HSCT. The increasing experience with HSCT in SJIA, suggests that despite the complicated ... ...

Abstract	It has been increasingly recognized that there is a subset of patients with refractory systemic JIA, who have failed all available medications and may benefit from HSCT. The increasing experience with HSCT in SJIA, suggests that despite the complicated post-HSCT course, short-term, the transplanted patients either achieved SJIA remission or reduced burden of disease. Longer follow-up, however, is needed to better define the long-term outcomes. The discussion at the NextGen 2022 conference was focused on the optimal timing for the procedure, the need for a good control of inflammatory SJIA activity prior to HSCT, and the role of the reduced intensity conditioning regimens as there was a remote concern that such regimens might increase the risk of SJIA relapse after the transplantation. There was unanimous agreement about the importance of long-term registries to address these questions.
MeSH term(s)	Humans ; Europe ; North America ; Registries ; Lung Diseases/therapy ; Hematopoietic Stem Cell Transplantation/adverse effects
Language	English
Publishing date	2024-01-05
Publishing country	England
Document type	Journal Article
ZDB-ID	2279468-2
ISSN	1546-0096 ; 1546-0096
ISSN (online)	1546-0096
ISSN	1546-0096
DOI	10.1186/s12969-023-00868-x
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Article: "Stemness" does not explain the repair of many tissues by mesenchymal stem/multipotent stromal cells (MSCs).

Prockop, D J

Clinical pharmacology and therapeutics

2007 Volume 82, Issue 3, Page(s) 241–243

Abstract: There has recently been an explosion of interest in adult stem/progenitor cells that have the potential to repair tissues, with over 3,000 citations to publications (PubMed) and numerous announcements of clinical trials in which the cells are used to ... ...

Abstract	There has recently been an explosion of interest in adult stem/progenitor cells that have the potential to repair tissues, with over 3,000 citations to publications (PubMed) and numerous announcements of clinical trials in which the cells are used to treat individuals with a broad range of diseases. At the same time, the data present a paradox-the cells originally attracted attention because of their stem-cell-like properties, but the cells frequently repair injured tissues without much evidence of either engraftment or differentiation.
MeSH term(s)	Animals ; Cell Differentiation/physiology ; Coculture Techniques ; Humans ; Mesenchymal Stem Cell Transplantation ; Mesenchymal Stromal Cells/physiology ; Multipotent Stem Cells/physiology ; Multipotent Stem Cells/transplantation ; Stromal Cells/physiology ; Stromal Cells/transplantation
Language	English
Publishing date	2007-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1038/sj.clpt.6100313
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Zs.A 20: Show issues

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Article ; Online: Impact of rabbit anti-thymocyte globulin (ATG) exposure on outcomes after ex vivo T-cell-depleted hematopoietic cell transplantation in pediatric and young adult patients.

Lakkaraja, Madhavi / Mauguen, Audrey / Boulad, Farid / Cancio, Maria I / Curran, Kevin J / Harris, Andrew C / Kernan, Nancy A / Klein, Elizabeth / Kung, Andrew L / Oved, Joseph / Prockop, Susan / Scaradavou, Andromachi / Spitzer, Barbara / O'Reilly, Richard J / Boelens, Jaap Jan

Cytotherapy

2024 Volume 26, Issue 4, Page(s) 351–359

Abstract: ... Center were retrospectively analyzed. rATG exposure post-HCT was estimated (AU*d/L) using a validated ... population pharmacokinetic model. Previously defined rATG-exposures, <30, 30-55, ≥55 AU*d/L, were related ... nonmalignant 56 (31%). Median post-HCT rATG exposure was 32 (0-104) AU*d/L. Exposure <30 AU*d/L was associated ...

Abstract	Background aims: Traditional weight-based dosing of rabbit anti-thymocyte globulin (rATG) used in allogeneic hematopoietic cell transplantation (HCT) to prevent graft-versus-host disease (GVHD) and graft rejection leads to variable exposures. High exposures induce delayed CD4+immune reconstitution (CD4+IR) and greater mortality. We sought to determine the impact of rATG exposure in children and young adults receiving various types of EX-VIVO T-cell-depleted (EX-VIVO-TCD) HCT. Methods: Patients receiving their first EX-VIVO-TCD HCT (CliniMACS CD34+, Isolex or soybean lectin agglutination), with removal of residual T cells by E-rosette depletion (E-) between 2008 and 2018 at Memorial Sloan Kettering Cancer Center were retrospectively analyzed. rATG exposure post-HCT was estimated (AUd/L) using a validated population pharmacokinetic model. Previously defined rATG-exposures, <30, 30-55, ≥55 AUd/L, were related with outcomes of interest. Cox proportional hazard and cause-specific models were used for analyses. Results: In total, 180 patients (median age 11 years; range 0.1-44 years) were included, malignant 124 (69%) and nonmalignant 56 (31%). Median post-HCT rATG exposure was 32 (0-104) AUd/L. Exposure <30 AUd/L was associated with a 3-fold greater probability of CD4+IR (P < 0.001); 2- to 4-fold lower risk of death (P = 0.002); and 3- to 4-fold lower risk of non-relapse mortality (NRM) (P = 0.02). Cumulative incidence of NRM was 8-fold lower in patients who attained CD4+IR compared with those who did not (P < 0.0001). There was no relation between rATG exposure and aGVHD (P = 0.33) or relapse (P = 0.23). Effect of rATG exposure on outcomes was similar in three EX-VIVO-TCD methods. Conclusions: Individualizing rATG dosing to target a low rATG exposure post-HCT while maintaining total cumulative exposure may better predict CD4+IR, reduce NRM and increase overall survival, independent of the EX-VIVO-TCD method.
MeSH term(s)	Humans ; Child ; Young Adult ; Antilymphocyte Serum ; Retrospective Studies ; T-Lymphocytes ; Hematopoietic Stem Cell Transplantation/adverse effects ; Graft vs Host Disease ; Transplantation Conditioning
Chemical Substances	Antilymphocyte Serum
Language	English
Publishing date	2024-02-12
Publishing country	England
Document type	Journal Article
ZDB-ID	2039821-9
ISSN	1477-2566 ; 1465-3249
ISSN (online)	1477-2566
ISSN	1465-3249
DOI	10.1016/j.jcyt.2024.01.004
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Zs.A 5601: Show issues

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Article ; Online: Engineering the best transplant outcome for high-risk acute myeloid leukemia: the donor, the graft and beyond.

Belbachir, Safia / Abraham, Allistair / Sharma, Akshay / Prockop, Susan / DeZern, Amy E / Bonfim, Carmem / Bidgoli, Alan / Li, Jinjing / Ruggeri, Annalisa / Bertaina, Alice / Boelens, Jaap Jan / Purtill, Duncan

Cytotherapy

2023

Abstract: Allogeneic hemopoietic cell transplantation remains the goal of therapy for high-risk acute myeloid leukemia (AML). However, treatment failure in the form of leukemia relapse or severe graft-versus-host disease remains a critical area of unmet need. ... ...

Abstract	Allogeneic hemopoietic cell transplantation remains the goal of therapy for high-risk acute myeloid leukemia (AML). However, treatment failure in the form of leukemia relapse or severe graft-versus-host disease remains a critical area of unmet need. Recently, significant progress has been made in the cell therapy-based interventions both before and after transplant. In this review, the Stem Cell Engineering Committee of the International Society for Cell and Gene Therapy summarizes the literature regarding the identification of high risk in AML, treatment approaches before transplant, optimal transplant platforms and measures that may be taken after transplant to ideally prevent, or, if need be, treat AML relapse. Although some strategies remain in the early phases of clinical investigation, they are built on progress in pre-clinical research and cellular engineering techniques that are already improving outcomes for children and adults with high-risk malignancies.
Language	English
Publishing date	2023-12-04
Publishing country	England
Document type	Journal Article
ZDB-ID	2039821-9
ISSN	1477-2566 ; 1465-3249
ISSN (online)	1477-2566
ISSN	1465-3249
DOI	10.1016/j.jcyt.2023.11.004
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Zs.A 5601: Show issues

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Article ; Online: Strategic infection prevention after genetically modified hematopoietic stem cell therapies: recommendations from the International Society for Cell & Gene Therapy Stem Cell Engineering Committee.

Cytotherapy

2024

Abstract: There is lack of guidance for immune monitoring and infection prevention after administration of ex vivo genetically modified hematopoietic stem cell therapies (GMHSCT). We reviewed current infection prevention practices as reported by providers ... ...

Abstract	There is lack of guidance for immune monitoring and infection prevention after administration of ex vivo genetically modified hematopoietic stem cell therapies (GMHSCT). We reviewed current infection prevention practices as reported by providers experienced with GMHSCTs across North America and Europe, and assessed potential immunologic compromise associated with the therapeutic process of GMHSCTs described to date. Based on these assessments, and with consensus from members of the International Society for Cell & Gene Therapy (ISCT) Stem Cell Engineering Committee, we propose risk-adapted recommendations for immune monitoring, infection surveillance and prophylaxis, and revaccination after receipt of GMHSCTs. Disease-specific and GMHSCT-specific considerations should guide decision making for each therapy.
Language	English
Publishing date	2024-02-20
Publishing country	England
Document type	Journal Article
ZDB-ID	2039821-9
ISSN	1477-2566 ; 1465-3249
ISSN (online)	1477-2566
ISSN	1465-3249
DOI	10.1016/j.jcyt.2024.02.005
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Article ; Online: Tabelecleucel for allogeneic haematopoietic stem-cell or solid organ transplant recipients with Epstein-Barr virus-positive post-transplant lymphoproliferative disease after failure of rituximab or rituximab and chemotherapy (ALLELE): a phase 3, multicentre, open-label trial.

The Lancet. Oncology

2024 Volume 25, Issue 3, Page(s) 376–387

Abstract: Background: Survival in Epstein-Barr virus (EBV)-positive post-transplant lymphoproliferative disease following haematopoietic stem-cell transplant (HSCT) or solid organ transplant (SOT) is poor after failure of initial therapy, indicating an urgent ... ...

Abstract	Background: Survival in Epstein-Barr virus (EBV)-positive post-transplant lymphoproliferative disease following haematopoietic stem-cell transplant (HSCT) or solid organ transplant (SOT) is poor after failure of initial therapy, indicating an urgent need for therapies for this ultra-rare disease. With recent EU marketing authorisation, tabelecleucel is the first off-the-shelf, allogeneic, EBV-specific T-cell immunotherapy to receive approval for treatment of relapsed or refractory EBV-positive post-transplant lymphoproliferative disease. We aimed to determine the clinical benefit of tabelecleucel in patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disease following HSCT or SOT. Methods: In this global, multicentre, open-label, phase 3 trial, eligible patients (of any age) had biopsy-proven EBV-positive post-transplant lymphoproliferative disease, disease that was relapsed or refractory to rituximab after HSCT and rituximab with or without chemotherapy after SOT, and partially HLA-matched and appropriately HLA-restricted tabelecleucel available. Patients received tabelecleucel administered intravenously at 2 × 10 Findings: From June 27, 2018, to Nov 5, 2021, 63 patients were enrolled, of whom 43 (24 [56%] male and 19 [44%] female) were included, 14 had prior HSCT, 29 had SOT. Seven (50%, 95% CI 23-77) of 14 participants in the HSCT group and 15 (52%, 33-71) of 29 participants in the SOT group had an objective response, with a median follow-up of 14·1 months (IQR 5·7-23·9) and 6·0 months (1·8-18·4), respectively. The most common grade 3 or 4 treatment-emergent adverse events were disease progression (in four [29%] of 14 in HSCT and eight [28%] of 29 in SOT) and decreased neutrophil count (in four [29%] of 14 in HSCT and four [14%] of 29 in SOT). Treatment-emergent serious adverse events were reported in 23 (53%) of 43 patients and fatal treatment-emergent adverse events in five (12%); no fatal treatment-emergent adverse event was treatment-related. There were no reports of tumour flare reaction, cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, transmission of infectious diseases, marrow rejection, or infusion reactions. No events of graft-versus-host disease or SOT rejection were reported as related to tabelecleucel. Interpretation: Tabelecleucel provides clinical benefit in patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disease, for whom there are no other approved therapies, without evidence of safety concerns seen with other adoptive T-cell therapies. These data represent a potentially transformative and accessible treatment advance for patients with relapsed or refractory disease with few treatment options. Funding: Atara Biotherapeutics.
MeSH term(s)	Humans ; Male ; Female ; Rituximab/adverse effects ; Herpesvirus 4, Human/genetics ; Epstein-Barr Virus Infections/drug therapy ; Epstein-Barr Virus Infections/etiology ; Alleles ; Lymphoproliferative Disorders/drug therapy ; Lymphoproliferative Disorders/etiology ; Organ Transplantation/adverse effects ; Hematopoietic Stem Cell Transplantation/adverse effects
Chemical Substances	Rituximab (4F4X42SYQ6)
Language	English
Publishing date	2024-01-31
Publishing country	England
Document type	Multicenter Study ; Journal Article
ZDB-ID	2049730-1
ISSN	1474-5488 ; 1470-2045
ISSN (online)	1474-5488
ISSN	1470-2045
DOI	10.1016/S1470-2045(23)00649-6
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Zs.A 5696: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 460: Show issues

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Article ; Online: Emapalumab as bridge to hematopoietic cell transplant for STAT1 gain-of-function mutations.

Kunvarjee, Binni / Bidgoli, Alan / Madan, Rebecca Pellett / Vidal, Esther / McAvoy, Devin / Hosszu, Kinga K / Scaradavou, Andromachi / Spitzer, Barbara G / Curran, Kevin J / Cancio, Maria / Harris, Andrew C / O'Reilly, Richard J / Kung, Andrew L / Prockop, Susan / Boelens, Jaap Jan / Oved, Joseph H

The Journal of allergy and clinical immunology

2023 Volume 152, Issue 3, Page(s) 815–817

MeSH term(s)	Humans ; Gain of Function Mutation ; Hematopoietic Stem Cell Transplantation ; Antibodies, Monoclonal/therapeutic use ; Antibodies, Monoclonal/genetics ; Antibodies, Neutralizing/genetics ; STAT1 Transcription Factor/genetics ; STAT1 Transcription Factor/metabolism ; Candidiasis, Chronic Mucocutaneous/genetics
Chemical Substances	Emapalumab ; Antibodies, Monoclonal ; Antibodies, Neutralizing ; STAT1 Transcription Factor ; STAT1 protein, human
Language	English
Publishing date	2023-06-26
Publishing country	United States
Document type	Letter ; Research Support, N.I.H., Extramural
ZDB-ID	121011-7
ISSN	1097-6825 ; 1085-8725 ; 0091-6749
ISSN (online)	1097-6825 ; 1085-8725
ISSN	0091-6749
DOI	10.1016/j.jaci.2023.05.016
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Uh III Zs.92: Show issues

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Article: Excellent leukemia control after second hematopoietic cell transplants with unrelated cord blood grafts for post-transplant relapse in pediatric patients.

Troullioud Lucas, Alexandre G / Boelens, Jaap Jan / Prockop, Susan E / Curran, Kevin J / Bresters, Dorine / Kollen, Wouter / Versluys, Birgitta / Bierings, Marc B / Archer, Anne / Davis, Eric / Klein, Elizabeth / Kernan, Nancy A / Lindemans, Caroline A / Scaradavou, Andromachi

Frontiers in oncology

2023 Volume 13, Page(s) 1221782

Abstract: Background: Patients with leukemia relapse after allogeneic hematopoietic cell transplant (HCT) have poor survival due to toxicity and disease progression. A second HCT often offers the only curative treatment.: Methods: We retrospectively reviewed ... ...

Abstract	Background: Patients with leukemia relapse after allogeneic hematopoietic cell transplant (HCT) have poor survival due to toxicity and disease progression. A second HCT often offers the only curative treatment. Methods: We retrospectively reviewed our bi-institutional experience (MSKCC-USA; Utrecht-NL) with unrelated cord blood transplantation (CBT) for treatment of post-transplant relapse. Overall survival (OS) and event-free survival (EFS) were evaluated using the Kaplan-Meier method, treatment-related mortality (TRM) and relapse were evaluated using the competing risk method by Fine-Gray. Results: Twenty-six patients age < 21 years received a second (n=24) or third (n=2) HCT with CB grafts during the period 2009-2021. Median age at first HCT (HCT1) was 11.5 (range: 0.9-17.7) years and all patients received myeloablative cytoreduction. Median time from HCT1 to relapse was 12.8 (range 5.5-189) months. At CBT, median patient age was 13.5 (range 1.4-19.1) years. Diagnoses were AML: 13; ALL: 4, MDS: 5, JMML: 2; CML: 1; mixed phenotype acute leukemia: 1. Sixteen patients (62%) were in advanced stage, either CR>2 or with active disease. Median time from HCT1 to CBT was 22.2 (range 7-63.2) months. All patients engrafted after CBT. Thirteen patients developed acute GvHD; 7 had grade III or IV. With a median survivor follow-up of 46.6 (range 17.4-155) months, 3-year OS was 69.2% (95% CI 53.6-89.5%) and 3-year EFS was 64.9% (95% CI 48.8-86.4%). Eight patients died, 3 of AML relapse and 5 due to toxicity (respiratory failure [n=4], GvHD [n=1]) at a median time of 7.7 (range 5.9-14.4) months after CBT. Cumulative incidence of TRM at 3 years was 19.2% (95% CI 4.1-34.4%). Notably, all TRM events occurred in patients transplanted up to 2015; no toxicity-related deaths were seen in the 16 patients who received CBT after 2015. Cumulative incidence of relapse was 15.9% (95% CI 1.6-30.2%) at 3 years, remarkably low for these very high-risk patients. Conclusions: Survival was very encouraging following CB transplants in pediatric patients with recurrent leukemia after first HCT, and TRM has been low over the last decade. CBT needs to be strongly considered as a relatively safe salvage therapy option for post-transplant relapse.
Language	English
Publishing date	2023-08-15
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2649216-7
ISSN	2234-943X
ISSN	2234-943X
DOI	10.3389/fonc.2023.1221782
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