Funding Resources 2019-08-23T19:40:00+00:00

Funding Resources Available

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Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 – Clinical Trial Required)

The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seek 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 will be required 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. Successful applicants proposing the use of adult stem cells as a clinical intervention will be asked to make available representative samples of the source stem cell and clinical-grade stem cell-derived product for in-depth and independent characterization through the RM Innovation Catalyst (see description in Section I).

Due to the complex nature of requirements in this FOA (e.g., 1:1 matching funds, resource sharing), applicants are strongly encouraged to communicate with the appropriate NIH Scientific/Research Contact and review online Frequently Asked Questions (FAQs) prior to submitting an application. Staff will be able to advise applicants in determining if their research meets the requirements and objectives of this FOA. 08-14-19 10-18-19
Methods to Improve Reproducibility of Human iPSC Derivation, Growth and Differentiation (SBIR) (R44 – Clinical Trial Not Allowed) Human induced pluripotent stem cells (iPSCs) have been used with great success to mimic the differentiation of a variety of tissues, understand early development and study human diseases. Despite approaches that have made the derivation, growth and differentiation of iPSCs more efficient, there remains significant variability in reprogramming efficacy, genomic integrity and developmental potential of iPSCs derived from a single fibroblast or tissue sample. Thus, iPSCs derived from the same sample may differ in their in vitro growth characteristics and their ability to re-differentiate into the desired tissue type. A variety of issues may affect derivation of the iPSCs and their growth, stability and differentiation, including the specific characteristics of the starting cell or tissue sample (e.g., age of donor, tissue type and anatomical location, physiological and disease state), the methods and protocols used to induce pluripotency (e.g., transcription factors, small molecules, cell fusion), the choice of growth factors and other culture conditions, method of storage of cell lines, etc. Further challenges include growing and maintaining sufficient quantities of iPSC lines in culture without changes in their properties, as well as the ability of multiple investigators to identify and authenticate iPSC lines as part of their research. This Funding Opportunity Announcement (FOA) will support SBIR projects to develop novel, reliable and cost-effective methods to standardize and increase the utility and reproducibility of iPSCs at all stages, from their derivation to their research and clinical applications. 12-06-19 01-06-20
Sartorius & Science Prize for Regenerative Medicine & Cell Therapy The Sartorius & Science Prize for Regenerative Medicine & Cell Therapy is an annual prize geared toward researchers focused on basic or translational research that advances regenerative medicine and cell therapy; for example cell-, gene-, or immunotherapy, tissue engineering, and materials engineering. Established in 2017, the prize is awarded for outstanding research performed by the applicant and as described in a 1,000 word essay.
The winner of the Sartorius & Science Prize for Regenerative Medicine & Cell Therapy is awarded US$25,000 and publication of his or her essay in Science. The Grand Prize essay and that of the Runner-up are also published on Science Online. The award is announced and presented at a ceremony for which Sartorius will provide financial support to help enable the grand prize winner to attend the ceremony Now 10-01-19
PAR-18-547: UG3/UH3 NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) 01-23-18 01-08-21
PAR-18-530: R01 Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 – Clinical Trial Optional) 02-28-18 01-08-21
PAR-16-093: R01 Improvement of Animal Models for Stem Cell-Based Regenerative Medicine (R01) 05-05-16 05-08-19
PAR-16-094: R21 Improvement of Animal Models for Stem Cell-Based Regenerative Medicine (R21) 03-08-16 05-08-19
PA-18-574: R43, R44 PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) 03-05-18 04-06-19
PA 18-575: R41, R42 PHS 2018-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed) 03-05-18 04-06-19
NOT-EB-18-026: R01 Notice of Intent to Issue the Funding Opportunity Announcement for Bioengineering Research Grants (BRG) (R01 Clinical Trial Not Allowed) 02-19-18 TBD
PA-19-075, R41 /R42 Enabling Technologies to Accelerate Development of Oral Biodevices (R41/R42 Clinical Trial Not Allowed) 03-05-19 01-06-2022
PA-19-076, R43/R44 Enabling Technologies to Accelerate Development of Oral Biodevices (R43/R44 Clinical Trial Not Allowed) 03-05-19 01-06-2022

To view background information regarding the Regenerative Medicine Innovation Project see NIH website here.