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Cytotherapy

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https://www.readbyqxmd.com/read/29934259/epigenetic-changes-in-umbilical-cord-mesenchymal-stromal-cells-upon-stimulation-and-culture-expansion
#1
Samantha F H DE Witte, Fleur S Peters, Ana Merino, Sander S Korevaar, Joyce B J VAN Meurs, Lisa O'Flynn, Steve J Elliman, Philip N Newsome, Karin Boer, Carla C Baan, Martin J Hoogduijn
BACKGROUND: Mesenchymal stromal cells (MSCs) are studied for their immunotherapeutic potential. Prior to therapeutic use, MSCs are culture expanded to obtain the required cell numbers and, to improve their efficacy, MSCs may be primed in vitro. Culture expansion and priming induce phenotypical and functional changes in MSCs and thus standardisation and quality control measurements come in need. We investigated the impact of priming and culturing on MSC DNA methylation and examined the use of epigenetic profiling as a quality control tool...
June 19, 2018: Cytotherapy
https://www.readbyqxmd.com/read/29907361/mesenchymal-stem-cell-expression-of-interleukin-35-protects-against-ulcerative-colitis-by-suppressing-mucosal-immune-responses
#2
Yongjia Yan, Na Zhao, Xianghui He, Hao Guo, Zhixiang Zhang, Tong Liu
BACKGROUND: Interleukin-35 (IL-35) has recently been identified as an immunosuppressive cytokine that has been used as a potential therapy for chronic inflammatory and autoimmune diseases. However, there remains a paucity of data regarding its potential benefits after integration into mesenchymal stem cells (MSCs). METHODS: We used a dextran sulfate sodium (DSS)-induced colitis mice model and treated them with IL-35-MSCs, MSCs or saline. The body weight was recorded daily and inflammatory processes were determined...
June 12, 2018: Cytotherapy
https://www.readbyqxmd.com/read/29859774/media-evaluation-for-production-and-expansion-of-anti-cd19-chimeric-antigen-receptor-t-cells
#3
Rehab Alnabhan, Ahmed Gaballa, Lisa-Mari Mörk, Jonas Mattsson, Michael Uhlin, Isabelle Magalhaes
BACKGROUND: The use of CD19 chimeric antigen receptor (CAR) T cells to treat B-cell malignancies has proven beneficial. Several groups use serum to produce CD19 CAR T cells. Today, ready-to-use serum-free media that require no addition of serum are commercially available. Therefore, it becomes important to evaluate the production of CD19 CAR T cells with and without the addition of serum. METHODS: T cells from buffy coats were cultured in AIM-V and TexMACS (TM) supplemented with 5% human serum (A5% and TM5%, respectively), and in TM without serum...
May 30, 2018: Cytotherapy
https://www.readbyqxmd.com/read/29859773/gene-therapy-for-sickle-cell-disease-an-update
#4
REVIEW
Selami Demirci, Naoya Uchida, John F Tisdale
Sickle cell disease (SCD) is one of the most common life-threatening monogenic diseases affecting millions of people worldwide. Allogenic hematopietic stem cell transplantation is the only known cure for the disease with high success rates, but the limited availability of matched sibling donors and the high risk of transplantation-related side effects force the scientific community to envision additional therapies. Ex vivo gene therapy through globin gene addition has been investigated extensively and is currently being tested in clinical trials that have begun reporting encouraging data...
May 30, 2018: Cytotherapy
https://www.readbyqxmd.com/read/29730080/a-decade-of-marketing-approval-of-gene-and-cell-based-therapies-in-the-united-states-european-union-and-japan-an-evaluation-of-regulatory-decision-making
#5
D G M Coppens, S de Wilde, H J Guchelaar, M L De Bruin, H G M Leufkens, P Meij, J Hoekman
There is a widely held expectation of clinical advance with the development of gene and cell-based therapies (GCTs). Yet, establishing benefits and risks is highly uncertain. We examine differences in decision-making for GCT approval between jurisdictions by comparing regulatory assessment procedures in the United States (US), European Union (EU) and Japan. A cohort of 18 assessment procedures was analyzed by comparing product characteristics, evidentiary and non-evidentiary factors considered for approval and post-marketing risk management...
May 2, 2018: Cytotherapy
https://www.readbyqxmd.com/read/29724571/bone-marrow-mesenchymal-stromal-cell-uptake-extracellular-vesicles-from-carbon-tetrachloride-injured-hepatocytes-without-differentiating-into-hepatocyte-like-cells-in-a-short-period
#6
LETTER
Virginia Andrea Angiolini, Carolina Uribe-Cruz, Graziella Rodrigues, Laura Simon, Mónica Luján López, Ursula Matte
No abstract text is available yet for this article.
April 30, 2018: Cytotherapy
https://www.readbyqxmd.com/read/29699860/summary-of-the-national-institute-of-standards-and-technology-and-us-food-and-drug-administration-cell-counting-workshop-sharing-practices-in-cell-counting-measurements
#7
Sheng Lin-Gibson, Sumona Sarkar, John T Elliott
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...
April 23, 2018: Cytotherapy
https://www.readbyqxmd.com/read/29680186/improved-cord-blood-thawing-procedure-enhances-the-reproducibility-and-correlation-between-flow-cytometry-cd34-cell-viability-and-clonogenicity-assays
#8
LETTER
Cristian Camilo Galindo, Diana María Vanegas Lozano, Bernardo Camacho Rodríguez, Ana-María Perdomo-Arciniegas
No abstract text is available yet for this article.
April 18, 2018: Cytotherapy
https://www.readbyqxmd.com/read/29853256/intrathecal-administration-of-autologous-mesenchymal-stromal-cells-for-spinal-cord-injury-safety-and-efficacy-of-the-100-3-guideline
#9
Jesús Vaquero, Mercedes Zurita, Miguel A Rico, Concepcion Aguayo, Celia Bonilla, Esperanza Marin, Noemi Tapiador, Marta Sevilla, David Vazquez, Joaquin Carballido, Cecilia Fernandez, Gregorio Rodriguez-Boto, Mercedes Ovejero
BACKGROUND AIMS: Cell therapy with autologous mesenchymal stromal cells (MSCs) in patients with spinal cord injury (SCI) is beginning, and the search for its better clinical application is an urgent need. METHODS: We present a phase 2 clinical trial in patients with chronic SCI who received three intrathecal administrations of 100 x 106 MSCs and were followed for 10 months from the first administration. Efficacy analysis was performed on nine patients, and safety analysis was performed on 11 patients...
June 2018: Cytotherapy
https://www.readbyqxmd.com/read/29807726/centralised-versus-decentralised-manufacturing-and-the-delivery-of-healthcare-products-a-united-kingdom-exemplar
#10
Richard P Harrison, Qasim A Rafiq, Nicholas Medcalf
BACKGROUND: The cell and gene therapy (CGT) field is at a critical juncture. Clinical successes have underpinned the requirement for developing manufacturing capacity suited to patient-specific therapies that can satisfy the eventual demand post-launch. Decentralised or 'redistributed' manufacturing divides manufacturing capacity across geographic regions, promising local, responsive manufacturing, customised to the end user, and is an attractive solution to overcome challenges facing the CGT manufacturing chain...
June 2018: Cytotherapy
https://www.readbyqxmd.com/read/29793831/illustrating-the-potency-of-current-good-manufacturing-practice-compliant-induced-pluripotent-stem-cell-lines-as-a-source-of-multiple-cell-lineages-using-standardized-protocols
#11
Mahendra S Rao, Ying Pei, Thelma Y Garcia, Shereen Chew, Toshiharu Kasai, Tomoko Hisai, Hideki Taniguchi, Takanori Takebe, Deepak A Lamba, Xianmin Zeng
We have previously reported the generation of a current Good Manufacture Practice (cGMP)-compliant induced pluripotent stem cell (iPSC) line for clinical applications. Here we show that multiple cellular products currently being considered for therapy can be generated from a single master cell bank of this or any other clinically compliant iPSC line METHODS: Using a stock at passage 20 prepared from the cGMP-compliant working cell bank (WCB), we tested differentiation into therapeutically relevant cell types of the three germ layers using standardized but generic protocols...
June 2018: Cytotherapy
https://www.readbyqxmd.com/read/29784434/cell-therapy-with-autologous-mesenchymal-stromal-cells-in-post-traumatic-syringomyelia
#12
Jesús Vaquero, Mercedes Zurita, Miguel A Rico, Concepcion Aguayo, Cecilia Fernandez, Gregorio Rodriguez-Boto, Esperanza Marin, Noemi Tapiador, Marta Sevilla, Joaquin Carballido, David Vazquez, Damian Garcia-Olmo, Hector Guadalajara, Miguel Leon, Ignacio Valverde
BACKGROUND AIMS: Recently, clinical studies show that cell therapy with mesenchymal stromal cells (MSCs) improves the sequelae chronically established in paraplegic patients, being necessary to know which of them can obtain better benefit. METHODS: We present here a phase 2 clinical trial that includes six paraplegic patients with post-traumatic syringomyelia who received 300 million MSCs inside the syrinx and who were followed up for 6 months. Clinical scales, urodynamic, neurophysiological, magnetic resonance (MR) and studies of ano-rectal manometry were performed to assess possible improvements...
June 2018: Cytotherapy
https://www.readbyqxmd.com/read/29784433/fda-and-nist-collaboration-on-standards-development-activities-supporting-innovation-and-translation-of-regenerative-medicine-products
#13
Judith A Arcidiacono, Steven R Bauer, David S Kaplan, Clare M Allocca, Sumona Sarkar, Sheng Lin-Gibson
The development of standards for the field of regenerative medicine has been noted as a high priority by several road-mapping activities. Additionally, the U.S. Congress recognizes the importance of standards in the 21st Century Cure Act. Standards will help to accelerate and streamline cell and gene therapy product development, ensure the quality and consistency of processes and products, and facilitate their regulatory approval. Although there is general agreement for the need of additional standards for regenerative medicine products, a shared understanding of standards is required for real progress toward the development of standards to advance regenerative medicine...
June 2018: Cytotherapy
https://www.readbyqxmd.com/read/29776835/the-combination-of-mannitol-and-temozolomide-increases-the-effectiveness-of-stem-cell-treatment-in-a-chronic-stroke-model
#14
Chunggab Choi, Hye Min Kim, Jeeheun Shon, Jiae Park, Hyeong-Taek Kim, Suk Ho Kang, Seung-Hun Oh, Nam Keun Kim, Ok Joon Kim
BACKGROUND: The blood-brain barrier (BBB) presents a significant challenge to the therapeutic efficacy of stem cells in chronic stroke. Various methods have been developed to increase BBB permeability, but these are associated with adverse effects and are, therefore, not clinically applicable. We recently identified that combination drug treatment of mannitol and temozolomide improved BBB permeability in vitro. Here, we investigated whether this combination could increase the effectiveness of stem cell treatment in an animal model of chronic ischemic stroke...
June 2018: Cytotherapy
https://www.readbyqxmd.com/read/29754771/epstein-barr-virus-specific-cytokine-induced-killer-cells-for-treatment-of-epstein-barr-virus-related-malignant-lymphoma
#15
Lisa-Marie Pfeffermann, Verena Pfirrmann, Sabine Huenecke, Melanie Bremm, Halvard Bonig, Hans-Michael Kvasnicka, Thomas Klingebiel, Peter Bader, Eva Rettinger
BACKGROUND: Prolonged immunosuppression or delayed T-cell recovery may favor Epstein-Barr virus (EBV) infection or reactivation after allogeneic hematopoietic stem cell transplantation (HSCT), which can lead to post-transplant lymphoproliferative disease (PTLD) and high-grade malignant B-cell lymphoma. Cytokine-induced killer (CIK) cells with dual specific anti-tumor and virus-specific cellular immunity may be applied in this context. METHODS: CIK cells with EBV-specificity were generated from peripheral blood mononuclear cells (PBMCs), expanded in the presence of interferon-γ, anti-CD3, interleukin (IL)-2 and IL-15 and were pulsed twice with EBV consensus peptide pool...
June 2018: Cytotherapy
https://www.readbyqxmd.com/read/29754770/skewing-effect-of-sulprostone-on-dendritic-cell-maturation-compared-with-dinoprostone
#16
Jenny Bulgarelli, Laura Fiammenghi, Serena Cassan, Anna Maria Granato, Massimiliano Petrini, Elena Pancisi, Valentina Soldati, Francesco De Rosa, Laura Ridolfi, Angela Riccobon, Massimo Guidoboni
BACKGROUND: Dendritic cells (DCs) are the most efficient antigen-presenting cells and act at the center of the immune system owing to their ability to control both immune tolerance and immunity. In cancer immunotherapy, DCs play a key role in the regulation of the immune response against tumors and can be generated ex vivo with different cytokine cocktails. METHODS: We evaluated the feasibility of dinoprostone (PGE2 ) replacement with the molecular analog sulprostone, in our good manufacturing practice (GMP) protocol for the generation of DC-based cancer vaccine...
June 2018: Cytotherapy
https://www.readbyqxmd.com/read/29753677/multicenter-phase-1-2-application-of-adenovirus-specific-t-cells-in-high-risk-pediatric-patients-after-allogeneic-stem-cell-transplantation
#17
Winnie Ip, Juliana M F Silva, Hubert Gaspar, Arindam Mitra, Shreenal Patel, Kanchan Rao, Robert Chiesa, Persis Amrolia, Kimberly Gilmour, Gul Ahsan, Mary Slatter, Andrew R Gennery, Robert F Wynn, Paul Veys, Waseem Qasim
BACKGROUND: Adenovirus (ADV) reactivation can cause significant morbidity and mortality in children after allogeneic stem cell transplantation. Antiviral drugs can control viremia, but viral clearance requires recovery of cell-mediated immunity. METHOD: This study was an open-label phase 1/2 study to investigate the feasibility of generating donor-derived ADV-specific T cells (Cytovir ADV, Cell Medica) and to assess the safety of pre-emptive administration of ADV-specific T cells in high-risk pediatric patients after allogeneic hematopoietic stem cell transplantation (HSCT) to treat adenoviremia...
June 2018: Cytotherapy
https://www.readbyqxmd.com/read/29709215/welcome-to-isct-2018-montreal
#18
EDITORIAL
(no author information available yet)
No abstract text is available yet for this article.
May 2018: Cytotherapy
https://www.readbyqxmd.com/read/29673565/scanning-the-horizon-for-high-value-add-manufacturing-science-accelerating-manufacturing-readiness-for-the-next-generation-of-disruptive-high-value-curative-cell-therapeutics
#19
Paul Hourd, David J Williams
BACKGROUND: Since the regenerative medicine sector entered the second phase of its development (RegenMed 2.0) more than a decade ago, there is increasing recognition that current technology innovation trajectories will drive the next translational phase toward the production of disruptive, high-value curative cell and gene-based regenerative medicines. AIM: To identify the manufacturing science problems that must be addressed to permit translation of these next generation therapeutics...
May 2018: Cytotherapy
https://www.readbyqxmd.com/read/29655599/plasma-from-some-cancer-patients-inhibits-adenoviral-ad5f35-vector-transduction-of-dendritic-cells
#20
Ping Jin, Wenjing Chen, Jiaqiang Ren, Steven Chen, Lauren Wood, Yingdong Zhao, Alan Remaley, Chauha Pham, Sheena Lian, Shutong Liu, Hui Liu, Steven Highfill, Jay A Berzofsky, David F Stroncek
BACKGROUND: Pooled AB serum is often used as a media supplement for cell culture but it has the potential to transmit infectious diseases. To avoid this risk, we used autologous plasma as a media supplement for manufacturing dendritic cells (DCs) for cancer immunotherapy. We noticed inconsistencies in the DCs and investigated their nature and cause. METHODS: Adenovirus human epidural growth factor receptor 2 (adHER2/neu) DCs for 21 patients were manufactured from autologous peripheral blood monocytes that were treated with granulocyte-macrophage colony-stimulating factor (GM-CSF) and interleukin (IL)-4 for 3 days, transduced with Ad5f35HER2ECTM and then treated with lipopolysaccharide and interferon (IFN)-γ for 1 day...
May 2018: Cytotherapy
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