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The National Institutes of Health (NIH) and participating NIH Institutes and Centers (ICs) and the U.S. Food and Drug Administration (FDA), through this Funding Opportunity Announcement (FOA), invite revision applications, from investigators with active R01 research project awards that will support clinical research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. A competing revision is a request for an increase in support in a current budget period for expansion of the project's approved scope or research protocol. These revision applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective regenerative medicine 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 product manufacturing, quality, safety, or effectiveness.

The National Institutes of Health (NIH) and participating NIH Institutes and Centers (ICs) and the U.S. Food and Drug Administration (FDA), through this Funding Opportunity Announcement (FOA), invite revision applications, from investigators with active R24 research project awards that will support clinical research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. A competing revision is a request for an increase in support in a current budget period for expansion of the project's approved scope or research protocol. These revision applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective regenerative medicine 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 product manufacturing, quality, safety, or effectiveness.

The National Institutes of Health (NIH) and participating NIH Institutes and Centers (ICs) and the U.S. Food and Drug Administration (FDA), through this Funding Opportunity Announcement (FOA), invite revision applications from investigators with active UM2 Program Project or Center with Complex Structure Cooperative Agreement awards that will support clinical research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. A competing revision is a request for an increase in support in a current budget period for expansion of the project's approved scope or research protocol. These revision applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective regenerative medicine 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 product manufacturing, quality, safety, or effectiveness.

The National Institutes of Health (NIH) and participating NIH Institutes and Centers (ICs) and the U.S. Food and Drug Administration (FDA), through this Funding Opportunity Announcement (FOA), invite revision applications from investigators with active P50 specialized center awards that will support clinical research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. A competing revision is a request for an increase in support in a current budget period for expansion of the project's approved scope or research protocol. These revision applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective regenerative medicine 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 product manufacturing, quality, safety, or effectiveness.

The National Institutes of Health (NIH) and participating NIH Institutes and Centers (ICs) and the U.S. Food and Drug Administration (FDA), through this Funding Opportunity Announcement (FOA), invite revision applications from investigators with active P41 research project awards that will support clinical research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. A competing revision is a request for an increase in support in a current budget period for expansion of the project's approved scope or research protocol. These revision applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective regenerative medicine 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 product manufacturing, quality, safety, or effectiveness.

The National Institutes of Health (NIH) and participating NIH Institutes and Centers (ICs) and the U.S. Food and Drug Administration (FDA), through this Funding Opportunity Announcement (FOA), invite revision applications, from investigators with active U01 research project awards that will support clinical research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. A competing revision is a request for an increase in support in a current budget period for expansion of the project's approved scope or research protocol. These revision applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective regenerative medicine 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 product manufacturing, quality, safety, or effectiveness.

The purpose of this FOA is to support the development and validation of pathophysiologically based preclinical outcome measures or functional markers that align closely with practical clinical assessments in spinal cord injury (SCI) and/or traumatic brain injury (TBI). Bedside knowledge and experience will be leveraged to create better assessment tools for preclinical studies, and the resulting data will be made available to researchers. The goal is to improve the value of preclinical studies to inform clinical diagnoses and prognoses and therapeutic translation.

This Limited Competition Funding Opportunity Announcement (FOA) invites applications to continue the activities of the National NeuroAIDS Tissue Consortium (NNTC) Clinical Sites as previously funded under RFA-MH-13-070. The NNTC Clinical Sites will function as part of the NNTC, a national resource that provides clinical data and biological specimens to NeuroAIDS investigators interested in conducting research toward a cure of Human Immunodeficiency Virus (HIV-1) infection from the central nervous system (CNS), and research on the neuropathogenesis of HIV-1 induced CNS and peripheral nervous system (PNS) dysfunction in the context of anti-retroviral therapy (ART). The NNTC Clinical Sites collect neuromedical and neuropsychiatric data from late stage, HIV-1 infected subjects who have indicated a willingness to participate in organ donation. The NNTC Clinical Sites are responsible for the following: 1) recruitment, clinical assessment and follow-up of the late-stage NNTC cohort; and 2) collection, maintenance and distribution of specimen resources. All data generated from these activities are transferred to the NNTC Data Coordinating Center (DCC). The NNTC Clinical Sites work cooperatively with the DCC to provide the clinical data and specimen resources to research investigators. A limited competition for the NNTC DCC is being sought under a separate but related companion FOA (RFA-MH-18-251).

This Limited Competition Funding Opportunity Announcement (FOA) invites one application to continue the activities of the Data Coordinating Center (DCC) of the National NeuroAIDS Tissue Consortium as previously funded under RFA-MH-13-071. The DCC will function as part of the NNTC, a national resource that provides clinical data and biological specimens to NeuroAIDS investigators interested in conducting research toward a cure of Human Immunodeficiency Virus (HIV-1) infection from the central nervous system (CNS), and research on the neuropathogenesis of HIV-1 induced CNS and peripheral nervous system (PNS) dysfunction in the context of anti-retroviral therapy (ART). The DCC works cooperatively with the NNTC-affiliated clinical sites to provide the following: 1) management and database capabilities to ensure effective clinical and brain banking operations, and to serve as the data repository for the NNTC; 2) scientific expertise in biostatistics and HIV-1 epidemiology to enable broad analyses of the NNTC clinical database, and to aid in statistical analysis of recruitment and retention goals for the clinical sites affiliated with the NNTC; and 3) expanding the capability to include coordinating the distribution of data and specimens stored at other national and international clinical sites to ensure that NeuroAIDS investigators have access to CNS and PNS resources that are difficult to obtain from HIV-1 infected individuals across the lifespan. The clinical sites affiliated with the NNTC will have all patient contact which will include all clinical assessments ante mortem. The clinical sites will also be responsible for the collection and housing of post mortem clinical specimens. The DCC will serve as a NeuroAIDS data repository which will include the clinical assessment data and data obtained post mortem including brain pathology reports, laboratory tests conducted on the collected specimens/fluids, a comprehensive inventory of those specimens housed at each clinical site, and research data, such as bioinformatics datasets. A limited competition application for the NNTC DCC is being sought under a separate but related companion FOA (RFA-MH-18-250)

This FOA encourages applications for the Lasker Clinical Research Scholars Program for the purpose of supporting the research activities during the early stage careers of independent clinical researchers.