Regenerative strategies may include the use of stem cell-derived precursors and/or progenitor cells as well as adult stem cells and products derived from these cells (e.g., exosomes or conditioned media) and/or employ methods for converting endogenous cells such as glia into PRCs or RGCs.
#Free clinical trials mop trial#
Applicants may use this grant to support the development of a detailed MOP, to collect safety/toxicity data, to conduct preliminary studies evaluating feasibility, or collecting other pre-clinical data of regenerative strategies as part of the planning process.Īn important aspect of this grant is that the research team is expected to plan for a treatment trial that addresses loss of vision using an approach that involves regenerating PRCs, RGCs and their connections, and/or regenerating optic nerve fibers. This Funding Opportunity Announcement (FOA) provides support for activities central to the refinement and completion of a study protocol and procedures necessary for implementing a clinical trial to evaluate interventions (or new treatments) that restore vision in humans through regeneration of cells.
These activities are often costly and time-consuming, and they may involve collection of preliminary data to assess feasibility. Additionally, there are other elements essential to the launching of a trial, such as obtaining regulatory authorizations or approvals and establishing agreements with requisite partners including cell manufacturing and production facilities, assay or cell analysis centers, and data coordinating centers.
#Free clinical trials mop manual#
Before a research team undertakes a clinical trial, it is critical to have clear delineation and documentation of the trial’s rationale, design, analytic techniques, protocols, and procedures in a Manual of Procedures (MOP). For example, AGI functional imaging projects developed new methods to noninvasively image cells and tissues of the visual system to evaluate the effects of regenerative therapies AGI discovery-based projects have identified factors such as genes, proteins, and other cellular messengers that are important for neural regeneration and could serve as interventional targets and AGI translation-enabling models projects are bridging the gap between basic and clinical research.Įxperimental interventions are evaluated in clinical trials. Although there has been some success in regenerating retinal neurons and connections in fish, mice, and other systems, the ultimate goal of the AGI is to restore vision in humans.ĪGI research has been laying the groundwork for clinical studies of new interventional strategies for reversing vision loss in humans. The retinal ganglion cells carry these signals from the photoreceptors to the brain. Photoreceptors - often called rods and cones - are cells in the retina that, when stimulated by light, generate signals the brain perceives as images. AGI research specifically targets photoreceptors (PRCs) and retinal ganglion cells (RGCs) in the eye. The National Eye Institute (NEI) Audacious Goal Initiative (AGI) is an effort to push the boundaries of vision science and restore vision through regeneration of cells in the retina. Renewal / Resubmission / Revision (as allowed) The following table includes NIH standard due dates marked with an asterisk.
These activities are often costly and time-consuming, and they may involve collection of preliminary data to assess feasibility. The Regenerative Medicine Clinical Trial Planning Grant may be used by applicants to support the preparation of a clinical trial MOP and procedures necessary for implementing a clinical trial to evaluate interventions (or new treatments) that restore vision in humans through regeneration of cells. The National Eye Institute (NEI) supports regenerative medicine clinical trials. Before a research team undertakes a clinical trial, it is critical to have clear delineation and documentation of the trial’s rationale, design, analytic techniques, protocols, and procedures in a Manual of Procedures (MOP).
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