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Stem cells and clinical trials

Mohamed Gadelkarim, Abdelrahman Ibrahim Abushouk, Esraa Ghanem, Ali Mohamed Hamaad, Anas M Saad, Mohamed M Abdel-Daim
With the increasing global prevalence of diabetes mellitus, a significant rise in the number of patients suffering from non-healing wounds is expected. However, available treatments, such as revascularization surgery and foot care education are often insufficient to ensure satisfactory wound healing. One therapeutic strategy that has been identified as particularly promising utilizes adipose-derived stem cells (ADSCs). Through a comprehensive literature search of published and ongoing studies, we aimed to provide an overview of the experimental basis, the scientific background, and advances in the delivery of ADSCs for treating non-healing diabetic wounds...
August 14, 2018: Biomedicine & Pharmacotherapy, Biomédecine & Pharmacothérapie
Paula Río, Susana Navarro, Juan Bueren
Fanconi anemia (FA) is a rare inherited disease associated with bone marrow failure (BMF) and cancer predisposition. Previous clinical trials have shown the difficulties of treating BMF of FA patients by gene therapy. Nevertheless, the discovery of new drugs capable of efficiently mobilizing hematopoietic stem cells (HSC) and the development of optimized procedures for transducing HSCs with safe integrative vectors, have markedly improved the efficiency for correcting the phenotype of hematopoietic repopulating cells from FA patients...
August 17, 2018: Human Gene Therapy
Domenico Maurizio Toraldo, Sara Toraldo, Luana Conte
Chronic obstructive pulmonary disease (COPD) is a disorder affecting more than 200 million people around the world, resulting in three million deaths per year. COPD is characterized by the loss of lung tissue and airway remodelling, with chronic inflammation of the airways and progressive destruction of lung parenchyma. The use of stem cells may lead to regenerative processes that address biological damage. However, this approach raises ethical issues that need to be considered in clinical trials using stem cell therapy, such as informed consent, patient recruitment and harm minimization, as well as the inherent uncertainty of these medical procedures on human beings...
September 2018: Journal of Clinical Medicine Research
Jeong-Seob Won, Hyun Nam, Hye Won Lee, Ji-Yoon Hwang, Yu-Jeong Noh, Do-Hyun Nam, Sun-Ho Lee, Kyeung Min Joo
Stem cells could be the next generation therapeutic option for neurodegenerative diseases including spinal cord injury (SCI). However, several critical factors such as delivery method should be determined before their clinical applications. Previously, we have demonstrated that lateral ventricle (LV) injection as preclinical simulation could be used for intrathecal administration in clinical trials using rodent animal models. In this study, we further analyzed in vivo distribution of cells that were injected into LVs of rats with SCI at thoracic level using in vivo imaging techniques...
2018: PloS One
Benedetta Maria Bonora, Roberta Cappellari, Mattia Albiero, Angelo Avogaro, Gian Paolo Fadini
Context: Reduction in the levels of circulating stem cells (CSCs) and endothelial progenitor cells (EPCs) predicts development or progression of micro- and macroangiopathy in patients with type 2 diabetes (T2D). Objective: We tested whether treatment with sodium glucose cotransporter-2 (SGLT2) inhibitors affected the levels of CSCs and EPCs. Design: A randomized trial of dapagliflozin versus placebo with open-label extension, and an open-label observational study of empagliflozin treatment...
August 2, 2018: Journal of Clinical Endocrinology and Metabolism
Young-Dan Cho, Kyung-Hwa Kim, Hyun-Mo Ryoo, Yong-Moo Lee, Young Ku, Yang-Jo Seol
BACKGROUND: Periodontitis is an inflammatory disease that can result in destruction of the tooth attachment apparatus. Therefore, periodontal tissue regeneration is currently an important focus of research in the field. Approaches using stem cells and reprogrammed cells, such as induced pluripotent stem cells (iPSCs) or trans-differentiated cells, represent the cutting edge in periodontal regeneration, and have led to many trials for their clinical application. Objectives and Results: In this review, we consider all available stem cell sources, methods to obtain the cells, their capability to differentiate into the desired cells, and the extent of their utilization in periodontal regeneration...
August 15, 2018: Current Stem Cell Research & Therapy
Eun Hye Park, Hee-Suk Lim, Seunghee Lee, Kyounghwan Roh, Kwang-Won Seo, Kyung-Sun Kang, Kichul Shin
Based on immunomodulatory actions of human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs), in vitro or preclinical studies of hUCB-MSCs have been conducted extensively in rheumatoid arthritis (RA). However, few human trials have investigated the outcomes of hUCB-MSC infusions. The CURE-iv trial was a phase 1, uncontrolled, open label trial for RA patients with moderate disease activity despite treatment with methotrexate. The patients received a single intravenous infusion of 2.5 × 107 , 5 × 107 , or 1 × 108 cells of hUCB-MSCs for 30 minutes, three patients in each cluster, with an increment of cell numbers when there was no dose-limited adverse event...
August 15, 2018: Stem Cells Translational Medicine
Christopher P Denton, Athol U Wells, John G Coghlan
Systemic sclerosis (SSc) is associated with high mortality owing to internal organ complications, and lung disease is the leading cause of SSc-associated death. The most notable lung complications in SSc are fibrosis and pulmonary arterial hypertension (PAH). A major challenge for the management of lung disease in SSc is detecting those patients with severe pathology and those patients who are likely to benefit from available treatments. In the past few years, strategies for managing lung fibrosis and pulmonary hypertension, including PAH, have greatly progressed...
August 15, 2018: Nature Reviews. Rheumatology
Allison Barz Leahy, Caitlin W Elgarten, Stephan A Grupp, Shannon L Maude, David T Teachey
Cure rates for pediatric and young adult patients with refractory or recurrently relapsed acute lymphoblastic leukemia are dismal. Survival from time of relapse is typically measured in weeks to months, and standard chemotherapy and currently approved targeted therapy achieve remission in less than a third of affected patients. To date, the only definitive curative therapy has been allogeneic hematopoietic stem cell transplant (HSCT). Advances in immunotherapy, with the introduction of chimeric antigen receptor T cell therapies and the development of tisagenlecleucel, have changed the landscape...
August 15, 2018: Expert Review of Anticancer Therapy
Shin-Yi Chung, Yen-Hsi Chen, Pei-Rong Lin, Ta-Chung Chao, Jung-Chen Su, Chung-Wai Shiau, Yeu Su
Signal transducer and activator of transcription 3 (STAT3) has been shown to play a critical role in the maintenance of cancer stem cells (CSCs). Hence, the inhibition of STAT3 signaling has been suggested to be a viable therapeutic approach for cancers. Moreover, the efficacy of combinations of chemotherapeutic drugs and napabucasin, a small-molecule STAT3 inhibitor, have been assessed in various clinical trials, including those involving patients with metastatic colorectal cancer (CRC). Two recently developed small-molecule STAT3 inhibitors, SC-43 and SC-78, which can stimulate SHP-1 to inactivate STAT3, were found to have anti-tumor activity...
2018: Cell Death Discovery
Samantha M Jaglowski, Bruce R Blazar
Allogeneic hematopoietic stem cell transplantation (allo-SCT) is potentially curative for a number of hematologic conditions, both malignant and nonmalignant. However, its success can be limited by the development of acute and chronic graft-versus-host disease (GVHD). Chronic GVHD (cGVHD) is the most common long-term complication following allo-SCT, and patients who develop this condition have significantly higher morbidity and mortality and significantly lower quality of life than patients who do not. Until recently, there were no US Food and Drug Administration (FDA)-approved therapies for cGVHD treatment...
August 14, 2018: Blood Advances
Leslie Padrnos, Brenda Ernst, Amylou C Dueck, Heidi E Kosiorek, Brenda F Ginos, Angela Toro, Patrick B Johnston, Thomas M Habermann, Jose F Leis, Joseph R Mikhael, Grzegorz S Nowakowski, Joseph Colgan, Luis Porrata, Stephen M Ansell, Thomas E Witzig, Craig Reeder
BACKGROUND: Treatment outcomes have improved in lymphoid malignancies but relapse remains inevitable for most patients. Everolimus and lenalidomide have shown clinical activity as single agents in patients with relapsed and refractory Hodgkin and non-Hodgkin lymphomas. PATIENTS AND METHODS: The present phase I/II trial for patients with relapsed and refractory lymphoid malignancy opened at Mayo Clinic from January 2011 to May 2013. The trial used a standard cohort 3 + 3 design to determine the maximum tolerated dose for the combination...
June 15, 2018: Clinical Lymphoma, Myeloma & Leukemia
Ali R Ahmadi, Maria Chicco, Russell N Wesson, Robert A Anders, Frank J M F Dor, Jan N M IJzermans, Tyler J Creamer, George M Williams, Zhaoli Sun, Andrew M Cameron
INTRODUCTION: Acute liver failure (ALF) affects 2000 Americans each year with no treatment options other than liver transplantation. We showed previously that mobilization of endogenous stem cells is protective against ALF in rodents. The objective of this study was to assess whether stem cell mobilizing drugs are lifesaving in a large animal preclinical model of ALF, to assess readiness for a clinical trial. METHODS: Male Yorkshire pigs (14-18 kg) were divided into 2 groups, control (n = 6) and treatment (n = 6)...
August 10, 2018: Annals of Surgery
Heiðdís B Valdimarsdottir, Mariana G Figueiro, William Holden, Susan Lutgendorf, Lisa M Wu, Sonia Ancoli-Israel, Jason Chen, Ariella Hoffman-Peterson, Julia Granski, Nina Prescott, Alejandro Vega, Natalie Stern, Gary Winkel, William H Redd
BACKGROUND: Over a third of multiple myeloma (MM) patients report clinical levels of depression during autologous stem cell transplant (ASCT) hospitalization. We report preliminary results from a randomized clinical trial investigating the effect of Programmed Environmental Illumination (PEI) of hospital rooms on depression. METHODS: Patients (N = 187) scheduled to receive an ASCT were assessed for eligibility. Those who met study eligibility criteria (n = 44) were randomly assigned to one of two PEI conditions involving delivery of either circadian active bright white light (BWL) or circadian inactive dim white light (DWL) throughout the room from 7 to 10 am daily during hospitalization...
August 11, 2018: Cancer Medicine
Chetasi Talati, David Sallman, Alan F List
Myelodysplastic syndrome (MDS) with deletion 5q [del(5q)] is a distinct clinical and pathologic disease subset that is exquisitely sensitive to lenalidomide for the treatment of red blood cell transfusion-dependent anemia. Lenalidomide resistance, including primary resistance, occurs by clonal evolution, which is frequently attributable to the presence of somatic mutations in the DNA-binding domain of the TP53 gene. The treatment options after development of resistance to lenalidomide are limited and consist of hypomethylating agents, clinical trials, and allogeneic hematopoietic stem cell transplantation...
July 30, 2018: Clinical Lymphoma, Myeloma & Leukemia
Wei Cai, Li-Dong Yu, Xiaowei Tang, Gan Shen
BACKGROUND AND OBJECTIVES: With the continued application of fat grafting in plastic surgery, many studies have focused on various factors to improve maintenance of the fat graft volume, such as platelet-rich plasma, adipose-derived stromal/stem cells, and the stromal vascular fraction (SVF). In addition, many review articles have investigated the functions of platelet-rich plasma and adipose-derived stromal/stem cells in fat grafting, although the usefulness of the SVF remains unclear...
September 2018: Annals of Plastic Surgery
E Archer Danielle, Reza Mafi, Pouya Mafi, Wasim Khan
BACKGROUND: Knee joint trauma may result in damage of the intra-articular ligaments, with rupture of the anterior cruciate ligament (ACL) a common and troublesome injury due to poor capabilities for spontaneous regeneration. Autograft and allograft surgical reconstructions are the mainstay of treatment, but have associated risks of failure, therefore tissue-engineering techniques aiming to regenerate the native ACL are being researched as a potential alternative treatment. OBJECTIVES: This article aims to review the current evidence produced by ex vivo and in vivo studies investigating biomaterial scaffolding and mesenchymal stem cell (MSC) techniques in orthopaedic tissue engineering of ACL injuries...
August 8, 2018: Current Stem Cell Research & Therapy
J Wehmeyer, M Zaiss, C Losem, S Schmitz, B Niemeier, J Harde, C V Hannig, H-D Harich, J Müller, M Klausmann, H W Tessen, K Potthoff
OBJECTIVE: Azacitidine (Vidaza® ) is the standard treatment for patients with higher-risk MDS not eligible for allogeneic stem cell transplantation. In the non-interventional study PIAZA we evaluated the effectiveness and safety of azacitidine-treatment in 149 patients with higher-risk MDS, CMML and AML in routine clinical practice. METHOD: Patients were treated according to physician's discretion. Besides evaluation of safety and effectiveness, impact of covariates on PFS was assessed...
August 9, 2018: European Journal of Haematology
Kazuya Kobayashi, Ken Suzuki
Transplantation of stem/progenitor cells is a promising, emerging treatment for heart failure (HF) in the modern era. Mesenchymal stem/stromal cells (MSCs) are considered as one of the most promising cell sources for this purpose, because of their powerful secretion of reparative factors and immunomodulatory ability. To date, various sources of MSCs have been examined for the treatment of HF in preclinical or clinical studies, including adult tissues (bone marrow and adipose tissue), perinatal tissues (umbilical cord and amnion), and pluripotent stem cells (induced pluripotent stem cells and embryonic stem cells)...
August 9, 2018: Circulation Journal: Official Journal of the Japanese Circulation Society
Jaclyn J Renfrow, Michael H Soike, Waldemar Debinski, Shakti H Ramkissoon, Ryan T Mott, Mark B Frenkel, Jann N Sarkaria, Glenn J Lesser, Roy E Strowd
Hypoxia is an important contributor to aggressive behavior and resistance mechanisms in glioblastoma. Upregulation of hypoxia inducible transcription factors (HIFs) is the primary adaptive cellular response to a hypoxic environment. While HIF1α has been widely studied in cancer, HIF2α offers a potentially more specific and appealing target in glioblastoma given expression in glioma stem cells and not normal neural progenitors, activation in states of chronic hypoxia and expression that correlates with glioma patient survival...
August 9, 2018: Future Medicinal Chemistry
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