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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...
May 18, 2018: Cytotherapy
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...
May 18, 2018: Cytotherapy
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...
May 15, 2018: Cytotherapy
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...
May 10, 2018: Cytotherapy
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...
May 10, 2018: Cytotherapy
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...
May 9, 2018: Cytotherapy
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
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
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
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
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...
April 16, 2018: Cytotherapy
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...
April 11, 2018: Cytotherapy
Jun Xu, J Joseph Melenhorst, Joseph A Fraietta
Cancer can be effectively targeted using a patient's own T cells equipped with synthetic receptors, including chimeric antigen receptors (CARs) that redirect and reprogram these lymphocytes to mediate tumor rejection. Over the past two decades, several strategies to manufacture genetically engineered T cells have been proposed, with the goal of generating optimally functional cellular products for adoptive transfer. Based on this work, protocols for manufacturing clinical-grade CAR T cells have been established, but these complex methods have been used to treat only a few hundred individuals...
April 10, 2018: Cytotherapy
Robert L Kruse, Thomas Shum, Haruko Tashiro, Mercedes Barzi, Zhongzhen Yi, Christina Whitten-Bauer, Xavier Legras, Beatrice Bissig-Choisat, Urtzi Garaigorta, Stephen Gottschalk, Karl-Dimiter Bissig
BACKGROUND: Chronic hepatitis B virus (HBV) infection remains incurable. Although HBsAg-specific chimeric antigen receptor (HBsAg-CAR) T cells have been generated, they have not been tested in animal models with authentic HBV infection. METHODS: We generated a novel CAR targeting HBsAg and evaluated its ability to recognize HBV+ cell lines and HBsAg particles in vitro. In vivo, we tested whether human HBsAg-CAR T cells would have efficacy against HBV-infected hepatocytes in human liver chimeric mice...
April 6, 2018: Cytotherapy
Bin Zhang, Ronne Wee Yeh Yeo, Ruenn Chai Lai, Eugene Wei Kian Sim, Keh Chuang Chin, Sai Kiang Lim
BACKGROUND AIMS: The immunomodulatory property of mesenchymal stromal cell (MSC) exosomes is well documented. On the basis of our previous report that MSC exosomes increased regulatory T-cell (Treg) production in mice with allogenic skin graft but not in ungrafted mice, we hypothesize that an activated immune system is key to exosome-mediated Treg production. METHODS: To test our hypothesis, MSC exosomes were incubated with mouse spleen CD4+ T cells that were activated with either anti-CD3/CD28 mAbs or allogenic antigen-presenting cell (APC)-enriched spleen CD11c+ cells to determine whether production of mouse CD4+ CD25+ T cells or CD4+ CD25+ Foxp3+ Tregs could be induced...
April 2, 2018: Cytotherapy
Charlotte de Wolf, Marja van de Bovenkamp, Marcel Hoefnagel
The adaptive immune system is known to play an important role in anti-neoplastic responses via induction of several effector pathways, resulting in tumor cell death. Because of their ability to specifically recognize and kill tumor cells, the potential use of autologous tumor-derived and genetically engineered T cells as adoptive immunotherapy for cancer is currently being explored. Because of the variety of potential T cell-based medicinal products at the level of starting material and manufacturing process, product-specific functionality assays are needed to ensure quality for individual products...
March 26, 2018: Cytotherapy
Atieh Makhlough, Soroosh Shekarchian, Reza Moghadasali, Behzad Einollahi, Mona Dastgheib, Ghasem Janbabaee, Seyedeh Esmat Hosseini, Nasrin Falah, Fateme Abbasi, Hossein Baharvand, Nasser Aghdami
BACKGROUND: Chronic kidney disease (CKD) is a progressive loss of kidney function and structure that affects approximately 13% of the population worldwide. A recent meta-analysis revealed that cell-based therapies improve impaired renal function and structure in preclinical models of CKD. We assessed the safety and tolerability of bone marrow-mesenchymal stromal cell (MSC) infusion in patients with CKD. METHODS: A single-arm study was carried out at one center with 18-month follow-up in seven eligible patients with CKD due to different etiologies such as hypertension, nephrotic syndrome (NS) and unknown etiology...
March 23, 2018: Cytotherapy
Lindsay C Davies, Emma Board-Davies, Berfin Shamlou, Erik Boberg, Karin Garming-Legert, Katarina Le Blanc
No abstract text is available yet for this article.
March 23, 2018: Cytotherapy
Guro Kristin Melve, Elisabeth Ersvaer, Kristin Paulsen Rye, Aymen Bushra Ahmed, Einar K Kristoffersen, Tor Hervig, Håkon Reikvam, Kimberley Joanne Hatfield, Øystein Bruserud
BACKGROUND: Peripheral blood stem cells from healthy donors mobilized by granulocyte colony-stimulating factor (G-CSF) and thereafter harvested by leukapheresis are commonly used for allogeneic stem cell transplantation. METHODS: Plasma levels of 38 soluble mediators (cytokines, soluble adhesion molecules, proteases, protease inhibitors) were analyzed in samples derived from healthy stem cell donors before G-CSF treatment and after 4 days, both immediately before and after leukapheresis...
March 22, 2018: Cytotherapy
Nan Zhang, Xianjie Lu, Shichao Wu, Xueli Li, Jing Duan, Chao Chen, Wei Wang, Hao Song, Jiabei Tong, Sen Li, Yanming Liu, Xinjiang Kang, Xuexiang Wang, Fabin Han
BACKGROUND: This study explored the neural differentiation and therapeutic effects of stem cells from human exfoliated deciduous teeth (SHED) in a rat model of Parkinson's disease (PD). METHODS: The SHED were isolated from fresh dental pulp and were induced to differentiate to neurons and dopamine neurons by inhibiting similar mothers against dpp (SMAD) signaling with Noggin and increase conversion of dopamine neurons from SHED with CHIR99021, Sonic Hedgehog (SHH) and FGF8 in vitro...
March 22, 2018: Cytotherapy
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