The Role of Stem/Progenitor Cells in the Pathogenesis and Treatment of Gynecologic Disorders (R01 - Clinical Trial Optional) | RFA HD 19 013

Opportunity Information: Apply for RFA HD 19 013

The funding opportunity titled "The Role of Stem/Progenitor Cells in the Pathogenesis and Treatment of Gynecologic Disorders (R01 - Clinical Trial Optional)" is a National Institutes of Health (NIH) research grant competition (Funding Opportunity Number: RFA-HD-19-013) focused on advancing scientific understanding of how pluripotent progenitor and stem cells contribute to both the development (pathogenesis) and potential treatment of several common gynecologic disorders. The FOA is framed around the idea that stem/progenitor cell populations may drive disease initiation, progression, recurrence, or treatment resistance, and that clarifying these mechanisms could open up new prevention strategies, diagnostics, or targeted therapies. While the mechanism is an R01 (a standard NIH research project grant), the announcement specifies that clinical trials are optional, meaning applicants may propose basic, translational, or clinically oriented studies, including clinical trials if appropriate, but they are not required.

The scientific scope is narrowly centered on five disorders: uterine fibroids, endometriosis, adenomyosis, endometrial polyps, and pelvic organ prolapse. In practical terms, proposals are expected to investigate stem/progenitor cell biology as it relates to these conditions, such as identifying relevant cell populations, mapping lineage relationships, characterizing signaling pathways that regulate abnormal growth or tissue remodeling, and exploring how microenvironmental factors (for example, inflammation, hormones, extracellular matrix cues, or mechanical forces) influence progenitor behavior in diseased tissue. The inclusion of both "pathogenesis" and "treatment" signals interest not only in descriptive or mechanistic studies, but also in work that can point toward interventions, such as ways to modulate progenitor cell activity, prevent lesion formation, reduce recurrence, or improve tissue repair and function.

From an administrative standpoint, this is a discretionary grant program in the Health, Income Security and Social Services category (CFDA number 93.865). The opportunity was created on 2017-12-08 and had an original closing date of 2018-03-30, indicating it is a time-limited competition from that period rather than an always-open solicitation. The listed award ceiling is $499,999, which sets an upper bound on funding per award under the terms shown in the provided source data. The number of expected awards is not specified in the excerpted information.

Eligibility is broad across many U.S.-based organizational types. Eligible applicants include state, county, and city/township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; and a wide variety of nonprofit organizations (including both 501(c)(3) and non-501(c)(3) nonprofits that are not institutions of higher education). The FOA also allows for-profit organizations (other than small businesses), small businesses, and an "other" category, which typically covers additional organization types permitted under NIH policy and the specific FOA language. It also explicitly highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. This emphasis suggests a desire to encourage wide participation, including institutions that serve groups historically underrepresented in biomedical research.

At the same time, there are clear restrictions regarding foreign involvement. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. In addition, foreign components as defined by the NIH Grants Policy Statement are not allowed under this FOA. In effect, the applicant organization and the project components must remain domestic, and collaborations cannot include foreign components in the NIH policy sense, even if they might be scientifically relevant.

Taken together, this FOA is best understood as a targeted NIH R01 initiative meant to push the field toward stem/progenitor cell-centered explanations and interventions for major gynecologic disorders that affect a large portion of the population and can cause chronic pain, abnormal bleeding, infertility, and reduced quality of life. Applicants would generally be expected to propose rigorous, hypothesis-driven research with clear relevance to one or more of the named disorders, using appropriate models and/or human tissues, and potentially including clinical research components when justified, all within the standard expectations of an NIH R01 award.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "The Role of Stem/Progenitor Cells in the Pathogenesis and Treatment of Gynecologic Disorders (R01 - Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
• This funding opportunity was created on 2017-12-08.
• Applicants must submit their applications by 2018-03-30. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $499,999.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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