Summary of the National Institute of Standards and Technology and US Food And Drug Administration cell counting workshop: Sharing practices in cell counting measurements.

Abstract:

:The emergence of cell-based therapeutics has increased the need for high-quality, robust and validated measurements for cell characterization. Cell count, being one of the most fundamental measures for cell-based therapeutics, now requires increased levels of measurement confidence. The National Institute of Standards and Technology (NIST) and the US Food and Drug Administration (FDA) jointly hosted a workshop focused on cell counting in April 2017 entitled "NIST-FDA Cell Counting Workshop: Sharing Practices in Cell Counting Measurements." The focus of the workshop was on approaches for selecting, designing and validating cell counting methods and overcoming gaps in obtaining sufficient measurement assurance for cell counting. Key workshop discussion points, representing approximately 50 subject matter experts from industry, academia and government agencies, are summarized here. A key conclusion is the need to design the most appropriate cell counting method, including control/measurement assurance strategies, for a specific counting purposes. There remains a need for documentary standards for streamlining the process to develop, qualify and validate cell counting measurements as well as community-driven efforts to develop new or improved biological and non-biological reference materials.

journal_name

Cytotherapy

journal_title

Cytotherapy

authors

Lin-Gibson S,Sarkar S,Elliott JT

doi

10.1016/j.jcyt.2018.03.031

subject

Has Abstract

pub_date

2018-06-01 00:00:00

pages

785-795

issue

6

eissn

1465-3249

issn

1477-2566

pii

S1465-3249(18)30470-5

journal_volume

20

pub_type

杂志文章,评审
  • Development of a surrogate angiogenic potency assay for clinical-grade stem cell production.

    abstract:BACKGROUND AIMS:Clinical results from acute myocardial infarction (AMI) patients treated with MultiStem®, a large-scale expanded adherent multipotent progenitor cell population (MAPC), have demonstrated a strong safety and benefit profile for these cells. The mechanism of benefit with MAPC treatment is a result, in par...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.3109/14653249.2012.688945

    authors: Lehman N,Cutrone R,Raber A,Perry R,Van't Hof W,Deans R,Ting AE,Woda J

    更新日期:2012-09-01 00:00:00

  • Combined immunotherapy with whole tumor lysate-pulsed interleukin-15-activated dendritic cells and cucurbitacin I promotes strong CD8(+) T-cell responses and cures highly aggressive lymphoma.

    abstract:BACKGROUND AIMS:Dendritic cell (DC)-based therapies could be important strategies for lymphoma treatment. METHODS:AKR/J mice with Dalton's lymphoma were treated with recombinant interleukin-15 (rIL-15)-activated autologous DCs and pulsed with whole tumor cell lysates in the presence or absence of suboptimal doses of t...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2015.01.006

    authors: Hira SK,Mondal I,Manna PP

    更新日期:2015-05-01 00:00:00

  • Current evidence on mesenchymal stem cell therapy for traumatic spinal cord injury: systematic review and meta-analysis.

    abstract:BACKGROUND AIMS:The authors aim to analyze the evidence in the literature regarding the efficacy and safety of mesenchymal stem cell (MSC) therapy in human subjects with traumatic spinal cord injury (SCI) and identify its potential role in the management of SCI. METHODS:The authors conducted independent and duplicate ...

    journal_title:Cytotherapy

    pub_type: 杂志文章,评审

    doi:10.1016/j.jcyt.2020.09.007

    authors: Muthu S,Jeyaraman M,Gulati A,Arora A

    更新日期:2020-11-09 00:00:00

  • Adoptive transfer of mesenchymal stromal cells accelerates intestinal epithelium recovery of irradiated mice in an interleukin-6-dependent manner.

    abstract:BACKGROUND AIMS:Apoptosis of radiosensitive cells in the bone marrow and gut is a serious, at times life-threatening, complication arising from radiation exposure. METHODS:We investigated whether adoptive transfer of allogeneic bone marrow-derived mesenchymal stromal cells (MSC) could exert cytoprotective and life-spa...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.3109/14653249.2012.684378

    authors: François M,Birman E,Forner KA,Gaboury L,Galipeau J

    更新日期:2012-11-01 00:00:00

  • Rapid ex vivo expansion of highly enriched human invariant natural killer T cells via single antigenic stimulation for cell therapy to prevent graft-versus-host disease.

    abstract:BACKGROUND AIMS:CD1d-restricted invariant natural killer (iNK) T cells are rare regulatory T cells that may contribute to the immune-regulation in allogeneic stem cell transplantation (ASCT). Here, we sought to develop an effective strategy to expand human iNK T cells for use in cell therapy to prevent graft-versus-hos...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2018.05.007

    authors: Trujillo-Ocampo A,Cho HW,Herrmann AC,Ruiz-Vazquez W,Thornton AB,He H,Li D,Qazilbash MA,Ma Q,Porcelli SA,Shpall EJ,Molldrem J,Im JS

    更新日期:2018-08-01 00:00:00

  • Simplified process for the production of anti-CD19-CAR-engineered T cells.

    abstract:BACKGROUND AIMS:Adoptive immunotherapy with the use of chimeric antigen receptor (CAR)-engineered T cells specific for CD19 has shown promising results for the treatment of B-cell lymphomas and leukemia. This therapy involves the transduction of autologous T cells with a viral vector and the subsequent cell expansion. ...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2013.06.003

    authors: Tumaini B,Lee DW,Lin T,Castiello L,Stroncek DF,Mackall C,Wayne A,Sabatino M

    更新日期:2013-11-01 00:00:00

  • Growth factor and cytokine expression of human mesenchymal stromal cells is not altered in an in vitro model of tissue damage.

    abstract:BACKGROUND AIMS:The beneficial effect of human (h) mesenchymal stromal cell (MSC) transplantation in a variety of cell-based intervention strategies is widely believed to be because of paracrine mechanisms. The modification of hMSC cytokine and growth-factor expression patterns were studied following exposure to lipopo...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.3109/14653249.2010.501789

    authors: Montzka K,Führmann T,Müller-Ehmsen J,Wöltje M,Brook GA

    更新日期:2010-11-01 00:00:00

  • Factors modulating circulation of hematopoietic progenitor cells in cord blood and neonates.

    abstract:BACKGROUND:Hematopoietic progenitor cells (HPC) circulate at high levels at birth and disappear rapidly afterwards, but the underlying mechanism it is not known. The aim of this study was to assess circulating HPC in cord blood at different gestational ages and shortly after birth and concomitantly study the biologic m...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1080/14653240802499148

    authors: Gonzalez S,Amat L,Azqueta C,Madrigal JA,Laïlla JM,Garcia J,Querol S

    更新日期:2009-01-01 00:00:00

  • Establishment, characterization and long-term culture of human endocrine pancreas-derived microvascular endothelial cells.

    abstract:BACKGROUND:In vitro primary cultures of microvascular endothelial cells from endocrine pancreas are difficult to obtain, but can be a very helpful tool for studies of islet biology, transplantation and regenerative medicine. METHODS:We applied a protocol recently described for the isolation and culture of brain microv...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2016.10.005

    authors: Sordi V,Ferri A,Ceserani V,Ciusani E,Dugnani E,Pellegrini S,Nano R,Pecciarini L,Pessina A,Pascucci L,Piemonti L,Alessandri G

    更新日期:2017-01-01 00:00:00

  • Adipose mesenchymal stromal cells minimize and repair radiation-induced oral mucositis.

    abstract:BACKGROUND AIMS:Mesenchymal stromal cells (MSCs) have been used to minimize and repair radiation-induced normal tissue injury in the intestine, salivary gland, liver, skin, lungs and cardiac muscle. This study investigated the ability of adipose tissue-derived MSCs (aMSCs) to minimize and/or repair single dose radiatio...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2016.06.008

    authors: Maria OM,Shalaby M,Syme A,Eliopoulos N,Muanza T

    更新日期:2016-09-01 00:00:00

  • Altered migration and adhesion potential of pro-neurally converted human bone marrow stromal cells.

    abstract:BACKGROUND:Bone marrow (BM)-derived mesenchymal stromal cells (MSC) are promising candidate cells for the development of neuroregenerative therapies. We have previously introduced the pro-neural conversion of human MSC to neural stem cell-like cells (m-NSC) by culturing them in suspension culture under serum-free condi...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1080/14653240802474331

    authors: Habisch HJ,Fiedler J,Ludolph AC,Storch A,Brenner RE

    更新日期:2008-01-01 00:00:00

  • Mesenchymal stromal cells from dermal and adipose tissues induce macrophage polarization to a pro-repair phenotype and improve skin wound healing.

    abstract::The process of wound healing restores skin homeostasis but not full functionality; thus, novel therapeutic strategies are needed to accelerate wound closure and improve the quality of healing. In this context, tissue engineering and cellular therapies are promising approaches. Although sharing essential characteristic...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2020.02.003

    authors: Zomer HD,Jeremias TDS,Ratner B,Trentin AG

    更新日期:2020-05-01 00:00:00

  • T lymphocytes engineered to express a CD16-chimeric antigen receptor redirect T-cell immune responses against immunoglobulin G-opsonized target cells.

    abstract:BACKGROUND AIMS:Chimeric antigen receptors (CARs) designed for adoptive immunotherapy need to achieve two functions: antigen recognition and triggering of the lytic machinery of reprogrammed effector cells. Cytotoxic T cells have been engineered with FcγRIII (CD16) chimeric molecules to be redirected against malignant ...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2015.10.014

    authors: D'Aloia MM,Caratelli S,Palumbo C,Battella S,Arriga R,Lauro D,Palmieri G,Sconocchia G,Alimandi M

    更新日期:2016-02-01 00:00:00

  • Dendritic cell-activated cytokine-induced killer cells enhance the anti-tumor effect of chemotherapy on non-small cell lung cancer in patients after surgery.

    abstract:BACKGROUND AIMS:Cytokine-induced killer (CIK) cells have shown cytolytic activity against several tumor cells in vitro and in animal tumor models. Furthermore, CIK cells activated by dendritic cell (DC) stimulation show increased anti-tumor activity. This study aimed to evaluate the clinical efficacy of DC-activated CI...

    journal_title:Cytotherapy

    pub_type: 临床试验,杂志文章

    doi:10.3109/14653240903121252

    authors: Li H,Wang C,Yu J,Cao S,Wei F,Zhang W,Han Y,Ren XB

    更新日期:2009-01-01 00:00:00

  • Improving efficacy of cancer immunotherapy by genetic modification of natural killer cells.

    abstract::Natural killer (NK) cells are members of the innate immune system that recognize target cells via activating and inhibitory signals received through cell receptors. Derived from the lymphoid lineage, NK cells are able to produce cytokines and exert a cytotoxic effect on viral infected and malignant cells. It is their ...

    journal_title:Cytotherapy

    pub_type: 杂志文章,评审

    doi:10.1016/j.jcyt.2016.05.018

    authors: Burga RA,Nguyen T,Zulovich J,Madonna S,Ylisastigui L,Fernandes R,Yvon E

    更新日期:2016-11-01 00:00:00

  • Induction of potent protection against acute and latent herpes simplex virus infection in mice vaccinated with dendritic cells.

    abstract:BACKGROUND AIMS:Dendritic cells (DCs) are the most potent antigen presenting cells of the immune system and have been under intense study with regard to their use in immunotherapy against cancer and infectious disease agents. In the present study, DCs were employed to assess their value in protection against live virus...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2012.11.012

    authors: Ghasemi M,Erturk M,Buruk K,Sonmez M

    更新日期:2013-03-01 00:00:00

  • Yield and proliferation rate of adipose-derived stromal cells as a function of age, body mass index and harvest site-increasing the yield by use of adherent and supernatant fractions?

    abstract:BACKGROUND AIMS:Adipose-derived stem cells are easily accessed and have a relatively high density compared with other mesenchymal stromal cells. Isolation protocols of adipose-derived stem cells (ASC) rely on the cell's ability to adhere to tissue culture plastic overnight. It was evaluated whether the floating ASC fra...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2013.04.009

    authors: Buschmann J,Gao S,Härter L,Hemmi S,Welti M,Werner CM,Calcagni M,Cinelli P,Wanner GA

    更新日期:2013-09-01 00:00:00

  • Safety and efficacy of granulocyte-colony-stimulating factor administration following autologous intramuscular implantation of bone marrow mononuclear cells: a randomized controlled trial in patients with advanced lower limb ischemia.

    abstract:BACKGROUND AIMS:The aim was to investigate the therapeutic effect of granulocyte-colony-stimulating factor (G-CSF) administration following implantation of autologous bone marrow mononuclear cells (BM MNC) for patients with lower limb ischemia. METHODS:The design was a randomized controlled trial. Fifteen patients wit...

    journal_title:Cytotherapy

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.3109/14653240903518163

    authors: Zafarghandi MR,Ravari H,Aghdami N,Namiri M,Moazzami K,Taghiabadi E,Fazel A,Pournasr B,Farrokhi A,Sharifian RA,Salimi J,Moini M,Baharvand H

    更新日期:2010-10-01 00:00:00

  • Removal process of prion and parvovirus from human platelet lysates used as clinical-grade supplement for ex vivo cell expansion.

    abstract:BACKGROUND AIMS:Pooled human platelet lysate (HPL) is becoming the new gold standard as supplement for ex vivo cell culture for clinical protocols. However, the risk of pathogen contamination of HPL increases with the platelet pool size. We hypothesized that hollow fiber anion exchange membrane chromatography using Qyu...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2016.04.002

    authors: Kao YC,Bailey A,Samminger B,Tanimoto J,Burnouf T

    更新日期:2016-07-01 00:00:00

  • In vitro cardiomyocyte differentiation of umbilical cord blood cells: crucial role for c-kit(+) cells.

    abstract:BACKGROUND AIMS:Although bone marrow c-kit(+) progenitor cells support myocardial regeneration, the cardiomyocyte differentiation potential of umbilical cord blood (UCB) c-kit(+) cells is unknown. METHODS:UCB mononuclear cells (MNCs) and c-kit(+) cells purified by use of immunomagnetic beads were used. Cardiomyocyte d...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2015.07.012

    authors: Iachininoto MG,Capodimonti S,Podda MV,Valentini CG,Bianchi M,Leone AM,Teofili L,Leone G

    更新日期:2015-11-01 00:00:00

  • A robust, good manufacturing practice-compliant, clinical-scale procedure to generate regulatory T cells from patients with amyotrophic lateral sclerosis for adoptive cell therapy.

    abstract::Regulatory T cells (Tregs) play a fundamental role in the maintenance of self-tolerance and immune homeostasis. Defects in Treg function and/or frequencies have been reported in multiple disease models. Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disorder affecting upper and lower motor neur...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2016.06.012

    authors: Alsuliman A,Appel SH,Beers DR,Basar R,Shaim H,Kaur I,Zulovich J,Yvon E,Muftuoglu M,Imahashi N,Kondo K,Liu E,Shpall EJ,Rezvani K

    更新日期:2016-10-01 00:00:00

  • CD133 immunomagnetic separation: effectiveness of the method for CD133(+) isolation from umbilical cord blood.

    abstract:BACKGROUND AIMS:Umbilical cord blood (UCB) is a rich source of stem cells, the characterization and isolation of which requires specific stem cell markers and reliable and reproducible protocols. METHODS:We assessed CD133 isolation in 39 UCB samples, using a commercial immunomagnetic cell-sorting protocol, and, becaus...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.3109/14653249.2012.663487

    authors: Pelagiadis I,Relakis K,Kalmanti L,Dimitriou H

    更新日期:2012-07-01 00:00:00

  • Human mesenchymal stromal cells transiently increase cytokine production by activated T cells before suppressing T-cell proliferation: effect of interferon-γ and tumor necrosis factor-α stimulation.

    abstract:BACKGROUND AIMS:Mesenchymal stromal cells (MSCs) suppress T-cell proliferation, especially after activation with inflammatory cytokines. We compared the dynamic action of unprimed and interferon (IFN)-γ plus tumor necrosis factor (TNF)-α-pretreated human bone marrow-derived MSCs on resting or activated T cells. METHOD...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2013.11.008

    authors: Cuerquis J,Romieu-Mourez R,François M,Routy JP,Young YK,Zhao J,Eliopoulos N

    更新日期:2014-02-01 00:00:00

  • Effect of cell therapy with allogeneic osteoblasts on bone repair of rat calvaria defects.

    abstract:BACKGROUND AIMS:Regenerative medicine strategies based on cell therapy are considered a promising approach to repair bone defects. The aims of this study were to evaluate the effect of subculturing on the osteogenic potential of osteoblasts derived from newborn rat calvaria and the effect of these osteoblasts on bone r...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2018.06.010

    authors: Souza ATP,Freitas GP,Lopes HB,Ferraz EP,Oliveira FS,Beloti MM,Rosa AL

    更新日期:2018-10-01 00:00:00

  • Clinical-grade myeloma Ag pre-loaded DC vaccines retain potency after cryopreservation.

    abstract:BACKGROUND:The use of myeloma Ag-loaded mature DC vaccines, cryopreserved in single-use aliquots, is an attractive immunotherapeutic strategy. In this study we investigated the retention of phenotype, viability and potency of DC vaccines after freezing and thawing. METHODS:Plastic-adherent monocytes, derived from a st...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1080/14653240510027235

    authors: Szmania S,Yi Q,Cottler-Fox M,Rosen NA,Freeman J,Kordsmeier BJ,Moreno A,Shi J,Barlogie B,Tricot G,van Rhee F

    更新日期:2005-01-01 00:00:00

  • Human umbilical cord mesenchymal stromal cells rescue mice from acetaminophen-induced acute liver failure.

    abstract:BACKGROUND AIMS:Acute liver failure (ALF), a life-threatening disease characterized by the sudden loss of hepatic function, can occur after an accidental or intentional acetaminophen overdose. METHODS:With the use of an ALF mouse model, we examined both the preventive and therapeutic potential of intravenously adminis...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2014.05.018

    authors: Liu Z,Meng F,Li C,Zhou X,Zeng X,He Y,Mrsny RJ,Liu M,Hu X,Hu JF,Li T

    更新日期:2014-09-01 00:00:00

  • Microbial contamination of cellular products for hematolymphoid transplantation therapy: assessment of the problem and strategies to minimize the clinical impact.

    abstract:BACKGROUND:Hematopoietic progenitor stem cells (HPSC) are a specialized transfusion product used for transplantation. Microbial contamination may occur during harvest or subsequent manipulation of these cells. The same difficulties in ensuring a safe, sterile, final product are faced in the preparation of other cell-th...

    journal_title:Cytotherapy

    pub_type: 杂志文章,评审

    doi:10.1080/14653240310003044

    authors: Lowder JN,Whelton P

    更新日期:2003-01-01 00:00:00

  • Ex vivo expansion of mafosfamide-purged PBPC products.

    abstract:BACKGROUND:Multiple studies have demonstrated that 'purging' of autografts with 4-hydroperoxycyclophosphamide (4HC) or the related compound mafosfamide (Mf), to eradicate residual leukemia, produces the best results associated with autologous blood and marrow transplantation for AML. However, 4HC purging results in pro...

    journal_title:Cytotherapy

    pub_type: 临床试验,杂志文章

    doi:10.1080/14653240600905353

    authors: McNiece I,Civin C,Harrington J,Kellner J,Malehorn M,Turney J,Barber J,Jones R

    更新日期:2006-01-01 00:00:00

  • Neural stem cells transplanted to the subretinal space of rd1 mice delay retinal degeneration by suppressing microglia activation.

    abstract:BACKGROUND AIMS:Retinal degeneration (RD) is an inherited eye disease characterized by irreversible photoreceptor loss. Conventionally, the activation of the resident microglia is secondary to the disease. Stem cell-based therapy has recently made rapid progress in treating RD. Although it has been demonstrated that th...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2016.03.001

    authors: Li Z,Zeng Y,Chen X,Li Q,Wu W,Xue L,Xu H,Yin ZQ

    更新日期:2016-06-01 00:00:00

  • A study of the immune properties of human umbilical cord lining epithelial cells.

    abstract:BACKGROUND AIMS:Our previous study has demonstrated the stem cell-like properties of human umbilical cord lining epithelial cells (CLECs) and their capability for epidermal reconstitution in organotypic skin culture; however, the immunogenicity of these cells has not been clearly defined. We assessed several aspects of...

    journal_title:Cytotherapy

    pub_type: 杂志文章

    doi:10.1016/j.jcyt.2013.10.008

    authors: Cai YJ,Huang L,Leung TY,Burd A

    更新日期:2014-05-01 00:00:00