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

Agency: National Institutes of Health

93.853 -- Extramural Research Programs in the Neurosciences and Neurological Disorders
93.173 -- Research Related to Deafness and Communication Disorders
93.847 -- Diabetes, Digestive, and Kidney Diseases Extramural Research
93.856 -- Microbiology and Infectious Diseases Research
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93.839 -- Blood Diseases and Resources Research
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93.242 -- Mental Health Research Grants
93.855 -- Allergy and Infectious Diseases Research
93.837 -- Cardiovascular Diseases Research
93.867 -- Vision Research
93.233 -- National Center on Sleep Disorders Research
93.840 -- Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders
93.846 -- Arthritis, Musculoskeletal and Skin Diseases Research
93.866 -- Aging Research

Archived opportunityLast Updated: May 13, 2026

Description

The National Institutes of Health (NIH), participating NIH Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite exploratory/developmental phased award cooperative agreement (UG3/UH3) applications to support investigator-initiated clinical trials (Phase I or later phase) aimed at furthering the field of regenerative medicine (RM) using adult stem cells. These applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that...

use RM products with demonstrated readiness to be advanced into clinical trials through appropriate product development and pre-clinical studies. Trials for which this FOA applies 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). This FOA utilizes a bi-phasic, milestone-driven cooperative agreement mechanism of award. This FOA seeks applications that present a strong scientific rationale for the clinical trial and a comprehensive scientific and operational plan. It is anticipated that applications will consist of plans for project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, data sharing, and dissemination of results. Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) application authorization or approval, respectively, to administer the product to humans. Due to the complex nature of conducting a clinical trial, applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application. Staff will be able to assist applicants in meeting the objectives of this FOA.

Eligibility

Eligible applicants

Education

Public and state institutions of higher education
Independent school districts
Private institutions of higher education

Nonprofit

Nonprofits non-higher education with 501(c)(3)
Other Native American tribal organizations
Nonprofits non-higher education without 501(c)(3)

Government

Federally recognized Native American tribal governments
County governments
Public and Indian housing authorities
State governments
Special district governments
City or township governments

Business

Small businesses
For-profit organizations other than small businesses

Miscellaneous

Other

Additional information

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Grantor contact information

Description

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV

Email

If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

FBOWebmaster@OD.NIH.GOV

Documents

No documents are currently available.

Link to additional information

http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-18-031.html

Archived: November 24, 2018

Application process

This site is a work in progress. Go to www.grants.gov to apply, track application status, and subscribe to updates.

Award

$--

Program Funding

Expected awards

$--

Award Minimum

$405,000

Award Maximum

Funding opportunity number:

RFA-HL-18-031

Cost sharing or matching requirement:

Funding instrument type:

Cooperative agreement

Opportunity Category:

Discretionary

Opportunity Category Explanation:

Category of Funding Activity:

Food and nutrition

Health

Category Explanation:

History

Version:

Posted date:

August 1, 2018

Archive date:

November 24, 2018