Human Subjects Mechanistic and Minimal Risk Studies (R01 Clinical Trial Optional)

Funding Opportunity PA-18-351 from the NIH Guide for Grants and Contracts. The purpose of this FOA is to encourage applications that seek to conduct studies of the visual system. This FOA will support applications that either Those that involve human subjects, but are not NIH-defined clinical trials (see NOT-OD-15-015); or Those that are NIH-defined clinical trials and are designed to address either: 1) mechanisms underlying human vision in health and disease; or 2) interventions that entail procedures with minimal risk to subjects. A mechanistic trial is defined as "A study designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. "Minimal risk" means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. NIH-defined clinical trial applications that are neither mechanistic nor minimal risk are not eligible for this FOA. Large-scale clinical trials, human gene-transfer and stem cell therapy trials, and other complex or high resource- or safety-risk clinical trials are not appropriate for this FOA. Applicants are strongly advised to consult with NEI program staff prior to submitting an application with human subjects to determine the appropriate funding opportunity.
Source: NIH Funding Opportunities (Notices, PA, RFA) - Category: Research Source Type: funding

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Abstract Human-induced pluripotent stem cell-derived hepatocyte-like cells (iHeps) constitute a powerful tool for modeling hepatotropic pathogen infections in cell culture. Meanwhile, CRISPR-Cas9 technology enables precise editing of stem cell genomes to generate patient-specific disease models and thus development of personalized experimental systems. Here we present a detailed stepwise protocol for the differentiation of stem cells to hepatocyte-like cells for HCV studies in cell culture. We also outline the use of an inducible iCRISPR platform for the rapid and efficient modification of host factors of interest...
Source: Mol Biol Cell - Category: Molecular Biology Authors: Tags: Methods Mol Biol Source Type: research
Authors: Johnen S, Koutsonas A Abstract The growing incidence of neurodegenerative diseases is based on our increasingly aging society as well as the difficulties in establishing defined therapy regimens. For dry age-related macular degeneration (AMD) and the later stage of geographic atrophy (GA), various treatment options exist that only decelerate the progression of the disease. However, no therapy is currently available that can restore the degenerated retinal pigment epithelium (RPE) and/or photoreceptor cells. Cellular and gene-based approaches aim for the regeneration of the degenerated cells and/or the cont...
Source: Klinische Monatsblatter fur Augenheilkunde - Category: Opthalmology Tags: Klin Monbl Augenheilkd Source Type: research
DiscussionThe improved stability obtained here will allow development of CiPA-compliant automated patch-clamp assays on hiPSC-CM. Future applications include the study of multi ion-channel blocking properties of drugs using dynamic-clamp protocols, adding a valuable new tool to the arsenal of safety-pharmacology.
Source: Journal of Pharmacological and Toxicological Methods - Category: Drugs & Pharmacology Source Type: research
This study demonstrates the notable potential of M-MSNs in promoting bone regeneration during DO by enhancing the osteogenic differentiation of MSCs, paving the way for clinical translation of M-MSNs in DO to repair large bone defects.Graphical AbstractTranslational potential of mesoporous silica coated iron oxide nanoparticles (M-MSNs) in regenerating long bone defects during distraction osteogenesis. Local injection of M-MSNs to the distraction gap promotes new bone formation and consolidation through enhancing the osteogenic differentiation of mesenchymal stem cells via the Wnt/β-catenin signaling pathway.
Source: Nanomedicine: Nanotechnology, Biology and Medicine - Category: Nanotechnology Source Type: research
Publication date: November 2019Source: Carbon, Volume 152Author(s): Tomáš Malina, Kateřina Poláková, Josef Skopalík, Věra Milotová, Kateřina Holá, Markéta Havrdová, Kateřina Bartoň Tománková, Vratislav Čmiel, Luděk Šefc, Radek ZbořilAbstractTissue regeneration based on stem cell therapy is one of the most rapidly developing fields of modern medicine. Several properties of human mesenchymal stromal cells (MSCs), such as tropism toward a tumor or injury site, make them promising candidates for regenerative medicine, targeted therapy, ...
Source: Carbon - Category: Materials Science Source Type: research
Authors: Zhou J, Liu HX, Li SH, Gong YS, Zhou MW, Zhang JH, Zhu GY Abstract OBJECTIVE: To investigate the role of human umbilical cord mesenchymal stem cell (hucMSC)-derived exosomes in the Wnt signaling pathway and their effects on fracture healing in rats. MATERIALS AND METHODS: A total of 24 healthy male Sprague-Dawley (SD) rats were randomly divided into 3 groups, of which the experimental groups were injected with Phosphate-Buffered Saline (PBS) and hUCMSC-derived exosomes, respectively, at the fracture site, and a blank control group was set. At 2 and 3 w after treatment, respectively, the healing conditi...
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
CONCLUSIONS: LncRNA MALAT1 was lowly expressed in OP rats. Moreover, it inhibited osteogenic differentiation of BMSCs by enhancing the activation of the MAPK signaling pathway, thereby promoting OP progression. PMID: 31210287 [PubMed - in process]
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
CONCLUSIONS: microRNA-1297 could regulate the osteogenesis of BMSCs by combining with WNT5A so as to accelerate the progression of osteoporosis. PMID: 31210281 [PubMed - in process]
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
Publication date: Available online 20 June 2019Source: Research in Veterinary ScienceAuthor(s): Woo-Jin Song, Qiang Li, Min-Ok Ryu, Aryung Nam, Ju-Hyun An, Yun Chan Jung, Jin-Ok Ahn, Hwa-Young YounAbstractCanine inflammatory bowel disease (IBD) is an intractable autoimmune disorder that results in various gastrointestinal and systemic symptoms. Mesenchymal stem cells (MSCs), which release immunomodulatory factors such as tumor necrosis factor-α (TNF-α)-induced gene/protein 6 (TSG-6) and prostaglandin E2 (PGE2), have been suggested as an alternative therapeutic option for IBD treatment in veterinary medicine. Fu...
Source: Research in Veterinary Science - Category: Veterinary Research Source Type: research
Publication date: Available online 19 June 2019Source: Journal of Microbiology, Immunology and InfectionAuthor(s): Kyoung Hwa Lee, Seul Gi Yoo, Yonggeun Cho, Da Eun Kwon, Yeonju La, Sang Hoon Han, Myoung Soo Kim, Jin Sub Choi, Soon Il Kim, Yu Seun Kim, Yoo Hong Min, June-Won Cheong, Jin Seok Kim, Yong Goo SongAbstractBackground/Purpose: Transplant recipients are vulnerable to life-threatening community-acquired respiratory viruses (CA-RVs) infection (CA-RVI). Even if non-transplant critically ill patients in intensive care unit (ICU) have serious CA-RVI, comparison between these groups remains unclear. We aimed to evaluate...
Source: Journal of Microbiology, Immunology and Infection - Category: Microbiology Source Type: research
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