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The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seeks highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Applications submitted in response to this bi-phasic, milestone-driven cooperative agreement FOA are expected to propose highly innovative projects with a focus on solutions to widely recognized issues in the development of safe and effective RM therapies. Of particular interest are projects using RM products that have undergone appropriate product development and pre-clinical studies and have demonstrated readiness to advance into clinical trials.

The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seeks highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Applications submitted in response to this bi-phasic, milestone-driven cooperative agreement FOA are expected to propose highly innovative projects with a focus on solutions to widely-recognized issues in the development of safe and effective RM therapies. Of particular interest are projects using RM products that have undergone appropriate product development and pre-clinical studies and have demonstrated readiness to advance into clinical trials. This FOA seeks Phase I and beyond clinical trial applications that present a strong scientific rationale for the proposed clinical trial and a comprehensive scientific and operational plan. Trials must be relevant to the research mission of one or more participating NIH Institutes and Centers and meet the NIH definition of a clinical trial (see NOT-OD-15-015). Applications are expected to include plans for project management, participant recruitment and retention, performance milestones, conduct of the trial, and dissemination of results. Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) authorization or Investigational New Device Exemption (IDE) approval to administer the product to humans.

This FOA encourages Research Project Grant (R01) applications from institutions and organizations proposing research aimed at characterizing animal stem cells and improving existing, and creating new, animal models for human disease conditions.The intent of this initiative is to facilitate the use of stem cell-based therapies for regenerative medicine. The initiative focuses on the following areas: 1) comparative analysis of animal and human stem cells to provide information for selection of the most predictive and informative model systems; 2) development of new technologies for stem cell characterization and transplantation; and 3) improvement of animal disease models for stem cell-based therapeutic applications.

This FOA encourages Research Project Grant (R01) applications from institutions and organizations proposing research aimed at characterizing animal stem cells and improving existing, and creating new, animal models for human disease conditions.The intent of this initiative is to facilitate the use of stem cell-based therapies for regenerative medicine. The initiative focuses on the following areas: 1) comparative analysis of animal and human stem cells to provide information for selection of the most predictive and informative model systems; 2) development of new technologies for stem cell characterization and transplantation; and 3) improvement of animal disease models for stem cell-based therapeutic applications.

The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite cooperative agreement (U01) applications to support investigator-initiated clinical research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. These applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that address critical issues in product development relevant for regulatory submissions. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of in-depth product characterization, manufacturing, potency, identity, quality, safety, in vivo function and integration, or effectiveness. Toward these ends, the NIH will consider applications for late-stage preclinical research studies involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development, including, but not limited to, the submission of an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) package; or to support such research conducted under an authorized IND or IDE.

Papers can be submitted in the following categories of nanomedicine research: Bioimaging & Drug Delivery Biosensing & Biophotonics Biophysics Modeling Instrumentation Regenerative Medicine Rehabilitative Engineering Tissue Engineering Biomaterials Biomechanics & Mechanobiology Biofuels & Bioenergy Molecular Cell Engineering Synthetic Biology Quantitative Systems Biology Stem Cells Bioengineering Education Education Start-up Companies Any research area of interest at the intersection of nanotechnology and medicine. The conference will be held on the campus of Northeastern University in Boston, MA, USA. The conference will include plenary speakers, oral and poster presentations, and numerous activities specifically for undergraduate and graduate students. As the focus of the conference is to highlight translational nanomedicine research, we will also focus on highlighting start-up companies and well-established companies in the nanomedicine sectors.

This FOA encourages Resource-Related Research Project Grant (R24) applications from institutions and organizations proposing research aimed at characterizing animal stem cells and improving existing and creating new animal models for human disease conditions. The intent of this initiative is to facilitate the use of stem cell-based therapies for regenerative medicine. The initiative focuses on the following areas: 1) comparative analysis of animal and human stem cells to provide information for selection of the most predictive and informative model systems; 2) development of new technologies for stem cell characterization and transplantation; and 3) improvement of animal disease models for stem cell-based therapeutic applications.

The mission of the Biomedical Engineering (BME) program is to provide opportunities to develop novel ideas into discovery-level and transformative projects that integrate engineering and life science principles in solving biomedical problems that serve humanity in the long-term.  The Biomedical Engineering (BME) program supports fundamental research in the following BME themes: Neural engineering (brain science, computational neuroscience, brain-computer interface, neurotech, cognitive engineering) Cellular biomechanics (motion, deformation, and forces in biological systems; how mechanical forces alter cell growth, differentiation, movement, signal transduction, transport, cell adhesion, cell cytoskeleton dynamics, cell-cell and cell-ECM interactions; genetically engineered stem cell differentiation with long-term impact in tissue repair and regenerative medicine) The BME projects must be at the interface of engineering and life sciences, and advance both engineering and life sciences.  The projects should focus on high impact transforming methods and technologies. The project should include methods, models and tools of understanding and controlling of living systems; fundamental improvements in deriving information from cells, tissues, organs, and organ systems; new approaches to the design of structures and materials for eventual medical use in the long-term; and new novel methods of reducing health care costs through new technologies. The projects should emphasize the advancement of fundamental engineering knowledge, possibly leading to the development of new methods and technologies in the long-term; and highlight multi-disciplinary nature, integrating engineering and the sciences. The long-term impact of the projects can be related to disease diagnosis and/or treatment, improved health care delivery, or product development.

The mission of the Biomedical Engineering (BME) program is to provide opportunities to develop novel ideas into discovery-level and transformative projects that integrate engineering and life science principles in solving biomedical problems that serve humanity in the long-term.  The Biomedical Engineering (BME) program supports fundamental research in the following BME themes: Neural engineering (brain science, computational neuroscience, brain-computer interface, neurotech, cognitive engineering) Cellular biomechanics (motion, deformation, and forces in biological systems; how mechanical forces alter cell growth, differentiation, movement, signal transduction, transport, cell adhesion, cell cytoskeleton dynamics, cell-cell and cell-ECM interactions; genetically engineered stem cell differentiation with long-term impact in tissue repair and regenerative medicine) The BME projects must be at the interface of engineering and life sciences, and advance both engineering and life sciences.  The projects should focus on high impact transforming methods and technologies. The project should include methods, models and tools of understanding and controlling of living systems; fundamental improvements in deriving information from cells, tissues, organs, and organ systems; new approaches to the design of structures and materials for eventual medical use in the long-term; and new novel methods of reducing health care costs through new technologies.

This Funding Opportunity Announcement (FOA) invites new research project applications to participate in the NIDDK (Re)Building a Kidney Consortium. The projects will be part of a research network focused on the expansion of tools, resources, and knowledge that will guide studies on the in vivo regeneration of functional nephrons or in vitro generation of nephrons for kidney transplant. Funds will be made available through the UH2/UH3 cooperative agreement award mechanism. The initial UH2 phase will support milestone-driven projects that will inform strategies for the enhancement of endogenous regenerative repair processes and generation of cell types important for the development of functional nephrons. UH2 projects that have met their scientific milestones will be eligible for transition to the second UH3 phase after NIH administrative review. The UH3 award is to provide a second phase for the support for innovative exploratory and development research activities initiated under the UH2 mechanism. UH3 phase will support milestone-driven projects. It is anticipated that relevant projects will be integrated as appropriate to further synergistic interactions and collaborations.

The FY15 JPC-8/CRMRP ERI is intended to support Phase I, II, or pivotal clinical trial phase development projects focused on extremity regeneration. The focus is on bone and soft tissue reconstruction, limb and tissue salvage technologies, and regenerative medicine technologies for the treatment of trauma-induced damage.

The Fiscal Year 2015 (FY15) Joint Program Committee 8/Clinical and Rehabilitative Medicine Research Program (JPC-8/CRMRP) Extremity Regeneration Technology/Therapeutic Development Award (ERTTDA) is intended to support the translation of promising preclinical findings into products focused on extremity regeneration. The focus is on bone and soft tissue reconstruction, limb and tissue salvage technologies, and regenerative medicine technologies for the treatment of trauma-induced damage.

The intent of this award is to fund an organization that can provide collaborative research assistance under three research focus areas:1) undersea medicine research, 2) regenerative medicine research and 3) neurotrauma research. The award will be issued as a cooperative agreement between the recipient and the Government (OUMD-NMRC (Operational and Undersea Medicine Directorate at Naval Medical Research Center)). The award recipient (awardee) will collaborate with OUMD-NMRC to develop and implement scientific research efforts and share substantial programmatic involvement with OUMD-NMRC.

þffThe National Institute of Dental and Craniofacial Research (NIDCR) is firmly committed to facilitating clinical translation of the most promising scientific and technological advances in tissue engineering and regenerative medicine (TE/RM) to safely and efficaciously regenerate and reconstruct dental, oral and craniofacial (DOC) tissues. Toward achieving this goal, NIDCR had established a multidisciplinary DOC Tissue Regeneration Consortium (DOCTRC) that consists of three Stages. For Stage 1, one year of support was provided under RFA-DE-15-005 through the R34 Planning Grant funding mechanism to develop an overall vision, roadmap, organizational structure, operational procedures and detailed plans for establishing centralized Resource Centers (RCs).

The purpose of this Funding Opportunity Announcement (FOA) is to invite applications for short-term, proof-of-principle research projects that will provide preliminary data for a future FOA aimed at the development of new models that emulate human visual system anatomy, physiology and disease processes. The model system might involve specific defects generated by transgenic gene insertion and/or deletion, gene editing, chemical/physical means, and/or other approaches to emulate characteristics of human disease or create defects amenable to cell-replacement and/or regenerative therapy. Using non-human primates or other cone-dominant species that are more representative of the anatomy and physiology of the human retina are highly encouraged. Other biological models are acceptable provided they meet the overall objectives of the FOA.

The purpose of this FOA is to stimulate development of translation-enabling models for evaluating survival and integration of regenerated photoreceptors (PRCs) and retinal ganglion cells (RGCs) in model systems that are closer to human visual anatomy, function and/or disease than current models. The development of these models, tools, devices, novel therapies and/or other resources is expected to provide a resource to vision researchers developing cell-replacement therapies for visual system diseases and disorders. This FOA seeks to develop models that emulate critical aspects of a human blinding disease that might be amenable to regenerative therapy. The model system might involve specific defects generated by transgenic gene insertion and/or deletion, gene editing, chemical/physical means, and/or other approaches to emulate characteristics of human disease or create defects amenable to cell-replacement therapy. Model systems using non-human primates or other cone-dominant species that are more representative of the anatomy and physiology of the human retina are highly encouraged. Other biological models are acceptable provided they meet the overall objectives of the FOA.

The Foundation Fighting Blindness, the world's leading organization searching for treatments and cures for inherited retinal diseases, is launching a new Translational Research Acceleration Program (TRAP) to help advance vision-saving research toward the clinical usage. The Foundation is accepting applications for retinal degeneration treatment approaches, including but not limited to: genetic therapies, regenerative treatments, and novel medical therapies. There are a variety of TRAP grant mechanisms that can provide up to $1.5 million in funding over three years.