Notice Number: NOT-HL-19-679
Release Date : February 07, 2019
Response Date : April 15, 2019
National Heart, Lung, and Blood Institute (NHLBI)
National Eye Institute (NEI)
National Institute on Aging (NIA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS )
National Center for Advancing Translational Sciences (NCATS)
This RFI is for information and planning purposes only, and should not be construed as a solicitation or an obligation on the part of the Federal Government and participating NIH Institutes and Centers (ICs). The participating NIH ICs do not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information. As part of NIH’s commitment to implementing the Regenerative Medicine Innovation Project (RMIP) established by the 21st Century Cures Act, the participating NIH ICs are soliciting input regarding in-depth cell characterization of human adult stem cells which are not of embryonic or fetal origin, including induced pluripotent stem cells (iPSCs) and mesenchymal stem cells (MSCs). The participating NIH ICs intend to apply state-of-the-art methods and approaches to the characterization of adult stem cells and derived cell products. This information will inform future strategies for assessing the safety and effectiveness of these cell products being developed for clinical applications. Toward this end, the participating NIH ICs are seeking input on which cell characteristics should be analyzed and the optimal methods/technologies for conducting these analyses. The information obtained from the in-depth characterization will help advance the field of regenerative medicine in numerous ways, including enhancing our scientific and clinical understanding of:
Current RM strategies focus on the delivery of therapeutic cells that restore normal structure and function as well as on leveraging and enhancing the body’s own innate healing capacity. A widely acknowledged challenge in stem cell research is that there are important cellular features that are not fully characterized beyond the quality attributes that are commonly used for assessing clinical grade products.1, 2 To address this knowledge gap and inform future avenues of scientific inquiry, the participating NIH ICs intend to analyze adult stem cells for key cell characteristics that can be correlated to the cells’ biological function, potency, and clinical efficacy. The participating NIH ICs will use the information submitted in response to this RFI at their discretion.
1. Regenerative Medicine Innovation Workshop – December 6-7, 2017
2. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: A Workshop – October 18, 2018
As part of its ongoing efforts to advance the field of RM, NIH RMIP will support in-depth cell characterization of human adult stem cell products (from non-embryonic or non-fetal sources but including iPSCs and MSCs) that have been developed for clinical application. The results of the in-depth cell characterization assays performed will be shared with the scientific community to increase understanding of adult stem cell and derived cell product characteristics and how they may predict clinical outcomes and safety. Toward this end, the participating NIH ICs seek input from the biomedical research community, small businesses, and other interested organizations and stakeholders on the best approaches to molecularly and functionally characterize adult stem cells used for clinical applications.
Participating NIH ICs seek comments on any or all of the following topics (where applicable, please include pertinent references and/or names of key experts):
How to Submit a Response
All responses to the RFI must be submitted via email to Joel Islam (firstname.lastname@example.org) by April 15, 2019. Please include the Notice Number, NOT-HL-19-679, in the subject line.
Responses to this RFI are voluntary. Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response. The responses will be reviewed by NIH staff, and individual feedback will not be provided to any responder. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public NIH websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.
This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government, the NIH, or individual NIH Institutes and Centers to provide support for any ideas identified in response to it. The Government will not pay for the preparation of any information submitted or for the Government’s use of such information. No basis for claims against the U.S. Government shall arise as a result of a response to this RFI or from the Government’s use of such information.
The participating NIH ICs look forward to your input and we hope that you will share this RFI document with your colleagues.
Please direct all inquiries to:
Joel Islam, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)