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Book ; Online: The Comprehensive Cancer Center : Development, Integration, and Implementation

Aljurf, Mahmoud / Majhail, Navneet S. / Koh, Mickey B.C. / Kharfan-Dabaja, Mohamed A. / Chao, Nelson J.

2022

Keywords	Oncology ; Medical administration & management ; Palliative medicine ; Inpatient Unit ; Radiation Therapy Facility ; Palliative Care ; Infusion Center ; Blood Bank ; Open Access
Size	1 electronic resource (193 pages)
Publisher	Springer Nature
Document type	Book ; Online
Note	English ; Open Access
HBZ-ID	HT021229784
ISBN	9783030820527 ; 3030820521
Database	ZB MED Catalogue: Medicine, Health, Nutrition, Environment, Agriculture

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Article: Considerations in setting up and planning a graft processing facility.

Koh, Mickey B C

Hematology/oncology and stem cell therapy

2017 Volume 10, Issue 4, Page(s) 195–197

Abstract: The graft processing facility forms one of the core components of a clinical haematopoietic stem cell transplant program. The quality of a graft is instrumental in leading to consistent and reproducible outcomes of engraftment and other parameters. As ... ...

Abstract	The graft processing facility forms one of the core components of a clinical haematopoietic stem cell transplant program. The quality of a graft is instrumental in leading to consistent and reproducible outcomes of engraftment and other parameters. As such, meticulous planning and consideration is required and will include core elements including physical design and clinical correlates. The successful running of such a facility depends on an overarching quality program and adherence to local and international regulatory guidelines.
MeSH term(s)	Graft Survival ; Guideline Adherence ; Hematopoietic Stem Cell Transplantation/methods ; Humans ; Practice Guidelines as Topic ; Quality of Health Care
Language	English
Publishing date	2017-12
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2651893-4
ISSN	1658-3876
ISSN	1658-3876
DOI	10.1016/j.hemonc.2017.12.001
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Article ; Online: Eye drops of human origin-Current status and future needs: Report on the workshop organized by the ISBT Working Party for Cellular Therapies.

Gabriel, Christian / Marks, Denese C / Henschler, Reinhard / Schallmoser, Katharina / Burnouf, Thierry / Koh, Mickey B C

Vox sanguinis

2023 Volume 118, Issue 4, Page(s) 301–309

Abstract: Background and objectives: Serum eye drops (SEDs) are used to treat ocular surface disease (OSD) and to promote ocular surface renewal. However, their use and production are not standardized, and several new forms of human eye drops have been developed.! ...

Abstract	Background and objectives: Serum eye drops (SEDs) are used to treat ocular surface disease (OSD) and to promote ocular surface renewal. However, their use and production are not standardized, and several new forms of human eye drops have been developed. Materials and methods: The International Society for Blood Transfusion Working Party (ISBT WP) for Cellular Therapies held a workshop to review the current types of eye drops of human origin (EDHO) status and provide guidance. Results: The ISBT WP for Cellular Therapies introduced the new terminology 'EDHO' to emphasize that these products are analogous to 'medical products of human origin'. This concept encompasses their source (serum, platelet lysate, and cord blood) and the increasingly diverse spectrum of clinical usage in ophthalmology and the need for traceability. The workshop identified the wide variability in EDHO manufacturing, lack of harmonized quality and production standards, distribution issues, reimbursement schemes and regulations. EDHO use and efficacy is established for the treatment of OSD, especially for those refractory to conventional treatments. Conclusion: Production and distribution of single-donor donations are cumbersome and complex. The workshop participants agreed that allogeneic EDHO have advantages over autologous EDHO although more data on clinical efficacy and safety are needed. Allogeneic EDHOs enable more efficient production and, when pooled, can provide enhanced standardization for clinical consistency, provided optimal margin of virus safety is ensured. Newer products, including platelet-lysate- and cord-blood-derived EDHO, show promise and benefits over SED, but their safety and efficacy are yet to be fully established. This workshop highlighted the need for harmonization of EDHO standards and guidelines.
MeSH term(s)	Humans ; Ophthalmic Solutions/therapeutic use ; Tissue Donors ; Treatment Outcome ; Serum ; Dry Eye Syndromes/drug therapy
Chemical Substances	Ophthalmic Solutions
Language	English
Publishing date	2023-02-27
Publishing country	England
Document type	Journal Article
ZDB-ID	80313-3
ISSN	1423-0410 ; 0042-9007
ISSN (online)	1423-0410
ISSN	0042-9007
DOI	10.1111/vox.13413
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Article ; Online: Prioritising health equity alongside donation safety - Authors' reply.

Koh, Mickey B C / Halter, Jörg P / Greinix, Hildegard T / Aljurf, Mahmoud / Worel, Nina

The Lancet. Haematology

2022 Volume 9, Issue 11, Page(s) e803–e804

MeSH term(s)	Humans ; Health Equity
Language	English
Publishing date	2022-09-22
Publishing country	England
Document type	Letter ; Comment
ISSN	2352-3026
ISSN (online)	2352-3026
DOI	10.1016/S2352-3026(22)00302-7
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Article ; Online: Radiation hazards of the Ukraine nuclear power plants: how can international blood and marrow stem cell transplant societies help?

Hashmi, Shahrukh K / Powles, Ray C / Ma, David / Muhsen, Ibrahim N / Aljurf, Mahmoud / Niederwieser, Dietger / Weisdorf, Daniel J / Koh, Mickey B C / Greinix, Hildegard

Annals of hematology

2023 Volume 103, Issue 4, Page(s) 1121–1129

Abstract: Any conflict in countries that process nuclear power plants raises concerns of the potential radiation injuries to the people in that region and beyond such as the current conflict in Ukraine. International healthcare organizations and societies should ... ...

Abstract	Any conflict in countries that process nuclear power plants raises concerns of the potential radiation injuries to the people in that region and beyond such as the current conflict in Ukraine. International healthcare organizations and societies should prepare for the potential scenarios of nuclear incidents. The Worldwide Network for Blood and Marrow Transplantation (WBMT) and its members, have recent experience preparing for this type of events such as the Fukushima incident in 2011. In this article, we discuss the risks of radiation exposure, current guidelines, and scientific evidence on hematopoietic support, including the role of hematopoietic stem cell transplant (HCT) for those exposed to nuclear radiation, and the role that the WBMT and other global BMT societies can play in triaging and managing people suffering from radiation injuries.
MeSH term(s)	Humans ; Nuclear Power Plants ; Bone Marrow ; Ukraine/epidemiology ; Hematopoietic Stem Cell Transplantation/adverse effects ; Radiation Injuries/epidemiology ; Radiation Injuries/etiology ; Stem Cell Transplantation
Language	English
Publishing date	2023-06-06
Publishing country	Germany
Document type	Journal Article ; Review
ZDB-ID	1064950-5
ISSN	1432-0584 ; 0939-5555 ; 0945-8077
ISSN (online)	1432-0584
ISSN	0939-5555 ; 0945-8077
DOI	10.1007/s00277-023-05191-9
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Article: Production and Quality Requirements of Human Platelet Lysate: A Position Statement from the Working Party on Cellular Therapies of the International Society of Blood Transfusion

Schallmoser, Katharina / Burnouf, Thierry / Gabriel, Christian / Henschler, Reinhard / Koh, Mickey B.C

Trends in biotechnology. 2019,

2019

Abstract: Human platelet lysate (HPL), rich in growth factors, is an efficient alternative supplement to fetal bovine serum (FBS) for ex vivo propagation of stromal cell-based medicinal products. Since 2014, HPL has been a focus of the Working Party for Cellular ... ...

Abstract	Human platelet lysate (HPL), rich in growth factors, is an efficient alternative supplement to fetal bovine serum (FBS) for ex vivo propagation of stromal cell-based medicinal products. Since 2014, HPL has been a focus of the Working Party for Cellular Therapies of the International Society of Blood Transfusion (ISBT). Currently, as several Good Manufacturing Practice (GMP)-compliant manufacturing protocols exist, an international consensus defining the optimal modes of industrial production, product specification, pathogen safety, and release criteria of this ancillary material (AM) is needed. This opinion article by the ISBT Working Party summarizes the current knowledge on HPL production and proposes recommendations on manufacturing and quality management in line with current technological innovations and regulations of biological products and advanced therapy medicinal products.
Keywords	blood transfusion ; fetal bovine serum ; good manufacturing practices ; growth factors ; humans ; manufacturing ; pathogens
Language	English
Publishing place	Elsevier Ltd
Document type	Article
Note	Pre-press version
ZDB-ID	47474-5
ISSN	1879-3096 ; 0167-7799
ISSN (online)	1879-3096
ISSN	0167-7799
DOI	10.1016/j.tibtech.2019.06.002
Database	NAL-Catalogue (AGRICOLA)

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Zs.A 2750: Show issues

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Article ; Online: An unusual presentation of neutropenic enterocolitis (typhlitis).

Youngs, Jonathan / Suarez, Cristina / Koh, Mickey B C

The Lancet. Infectious diseases

2016 Volume 16, Issue 5, Page(s) 618

Language	English
Publishing date	2016-05
Publishing country	United States
Document type	Journal Article
ZDB-ID	2061641-7
ISSN	1474-4457 ; 1473-3099
ISSN (online)	1474-4457
ISSN	1473-3099
DOI	10.1016/S1473-3099(15)00399-0
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Article ; Online: A novel simplified method of generating cytomegalovirus-specific cytokine-induced killer cells of high specificity and superior potency with GMP compliance.

Luah, Yen Hoon / Sundar Raj, Kirubavathy / Koh, Mickey B C / Linn, Yeh Ching

Clinical immunology (Orlando, Fla.)

2019 Volume 205, Page(s) 83–92

Abstract: We describe a method of rendering polyclonal cytokine-induced killer cells (CIK) specific against cytomegalovirus (CMV), focusing on GMP compliance. Peripheral blood mononuclear cells (PBMNC) are stimulated with pooled CMV peptides pp65 and IE-1 for 16- ... ...

Abstract	We describe a method of rendering polyclonal cytokine-induced killer cells (CIK) specific against cytomegalovirus (CMV), focusing on GMP compliance. Peripheral blood mononuclear cells (PBMNC) are stimulated with pooled CMV peptides pp65 and IE-1 for 16-24 h and the reactive T cell subset which up-regulate CD137 is further co-stimulated with anti-CD137, followed by expansion in G-Rex flasks under standard CIK culture condition. This method generates a large number CMV-specific CIK with superior potency compared to published method currently in clinical trials. The cytotoxicity as measured by chromium release assay correlates with the upregulation of CD107a upon peptide re-challenge as measured by flow cytometry. CMV-CIK at maturity consist of mainly late effector memory CD8 T cells and have a skewed TCR repertoire with preferential expansion of a few families. Such CMV-CIK retain their function after freezing and thawing. CMV-CIK thus generated is ready for clinical trial against drug-resistant CMV disease.
MeSH term(s)	CD8-Positive T-Lymphocytes/cytology ; CD8-Positive T-Lymphocytes/immunology ; Cell Culture Techniques/methods ; Cytokine-Induced Killer Cells/cytology ; Cytokine-Induced Killer Cells/immunology ; Cytomegalovirus/immunology ; Humans ; Immediate-Early Proteins/immunology ; Immunologic Memory/immunology ; Leukocytes, Mononuclear/cytology ; Leukocytes, Mononuclear/immunology ; T-Lymphocyte Subsets/cytology ; T-Lymphocyte Subsets/immunology ; T-Lymphocytes, Cytotoxic/cytology ; T-Lymphocytes, Cytotoxic/immunology ; Viral Matrix Proteins/immunology
Chemical Substances	IE1 protein, cytomegalovirus ; Immediate-Early Proteins ; Viral Matrix Proteins ; cytomegalovirus matrix protein 65kDa
Language	English
Publishing date	2019-06-21
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1459903-x
ISSN	1521-7035 ; 1521-6616
ISSN (online)	1521-7035
ISSN	1521-6616
DOI	10.1016/j.clim.2019.06.007
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Article ; Online: Production and Quality Requirements of Human Platelet Lysate: A Position Statement from the Working Party on Cellular Therapies of the International Society of Blood Transfusion.

Schallmoser, Katharina / Henschler, Reinhard / Gabriel, Christian / Koh, Mickey B C / Burnouf, Thierry

Trends in biotechnology

2019 Volume 38, Issue 1, Page(s) 13–23

Abstract	Human platelet lysate (HPL), rich in growth factors, is an efficient alternative supplement to fetal bovine serum (FBS) for ex vivo propagation of stromal cell-based medicinal products. Since 2014, HPL has been a focus of the Working Party for Cellular Therapies of the International Society of Blood Transfusion (ISBT). Currently, as several Good Manufacturing Practice (GMP)-compliant manufacturing protocols exist, an international consensus defining the optimal modes of industrial production, product specification, pathogen safety, and release criteria of this ancillary material (AM) is needed. This opinion article by the ISBT Working Party summarizes the current knowledge on HPL production and proposes recommendations on manufacturing and quality management in line with current technological innovations and regulations of biological products and advanced therapy medicinal products.
MeSH term(s)	Biological Products ; Biotechnology ; Blood Platelets/chemistry ; Blood Platelets/cytology ; Blood Platelets/metabolism ; Blood Transfusion ; Cell Culture Techniques ; Cell- and Tissue-Based Therapy ; Cells, Cultured ; Culture Media ; Humans ; Intercellular Signaling Peptides and Proteins ; Mesenchymal Stem Cells ; Transfusion Medicine/organization & administration
Chemical Substances	Biological Products ; Culture Media ; Intercellular Signaling Peptides and Proteins
Language	English
Publishing date	2019-07-17
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	47474-5
ISSN	1879-3096 ; 0167-7799
ISSN (online)	1879-3096
ISSN	0167-7799
DOI	10.1016/j.tibtech.2019.06.002
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Article ; Online: Human platelet lysate current standards and future developments.

Henschler, Reinhard / Gabriel, Christian / Schallmoser, Katharina / Burnouf, Thierry / Koh, Mickey B C

Transfusion

2019 Volume 59, Issue 4, Page(s) 1407–1413

Abstract: A state-of-the-art workshop focused on the use of human platelet lysate (HPL) for cell therapy. The meeting established that HPL is used mainly as an adjunct material for ex vivo expansion of mesenchymal stem/progenitor cells (MSCs), where it is ... ...

Abstract	A state-of-the-art workshop focused on the use of human platelet lysate (HPL) for cell therapy. The meeting established that HPL is used mainly as an adjunct material for ex vivo expansion of mesenchymal stem/progenitor cells (MSCs), where it is successfully used as a substitute for fetal bovine serum. HPL manufacturing as a cell expansion supplement is currently not yet uniformly standardized with regard to platelet source and production methodology. There are very few reports of HPL preparations manufactured specifically for direct clinical use. There exists an urgent need for controlled clinical studies for HPL and for standardization of product definition. Workshop participants also stated a need for consensus minimum release criteria to allow for better product definition and to limit variability in performance. The increasing use of cell-based therapies including MSCs has led to an increasing demand for HPL, either produced in blood establishments or large-scale manufacture by biopharmaceutical companies. The use of pooled donor platelets for HPL production may require the implementation of pathogen inactivation procedures and/or removal steps to improve the safety of advanced cell therapy products. There should also be a requirement for thorough risk assessments and risk mitigation steps, including the qualification of suppliers and identification of ingredients as well as meticulous monitoring of product quality and safety profiles. State-of-the-art regulatory approaches for HPL used for human cell propagation and PRP in direct clinical applications were reviewed.
MeSH term(s)	Animals ; Blood Platelets/chemistry ; Cattle ; Cell Extracts/chemistry ; Cell Extracts/standards ; Cell Extracts/therapeutic use ; Cell- and Tissue-Based Therapy ; Education ; Humans ; Mesenchymal Stem Cells/metabolism
Chemical Substances	Cell Extracts
Language	English
Publishing date	2019-02-11
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	208417-x
ISSN	1537-2995 ; 0041-1132
ISSN (online)	1537-2995
ISSN	0041-1132
DOI	10.1111/trf.15174
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