Opportunity Information: Apply for RFA RM 12 001
Apply for RFA RM 12 001
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Stem/Progenitor Cell Derived Human Micro organs and tissues (U18)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.310 Trans NIH Research Support.
- This funding opportunity was created on Nov 23, 2011 and posted on Nov 23, 2011.
- Applicants must submit their applications by Jan 26, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following For a Diversity FOA that restricts eligibility by targeting diverse institutions, insert standard Diversity language regarding eligible institutions here. (see Lisa Evans,OER). Note that FOAs can target institutions or individuals but not both.
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Opportunity Summary:
The NIH funding opportunity "Stem/Progenitor Cell Derived Human Micro-organs and Tissues (U18)" (RFA-RM-12-001) sought projects that could build advanced, human, multi-cellular in vitro models that reproduce meaningful aspects of real human organ physiology. The central idea was to move beyond basic 3D culture and toward micro-organs or tissue modules derived from stem or progenitor cells that capture key biological features seen in living organs, including multiple interacting cell types, appropriate tissue architecture, and measurable, repeatable functional outputs under normal (physiological) conditions. These models were expected to address challenging elements of human biology that often limit traditional cell culture systems, such as disease mechanisms (pathogenesis), cell-type diversity, genomic complexity, and the ability to monitor and control cell-to-cell, cell-to-matrix, and microenvironmental interactions that shape tissue behavior.
A major emphasis of the FOA was on building systems that are not only biologically credible but also reproducible and useful as platforms for testing therapies. Applicants were expected to demonstrate that their micro-tissue models produce consistent cellular signatures (for example, stable marker profiles and gene expression patterns) and reliable functional readouts relevant to the organ being modeled (such as contractility for cardiac tissues, secretion and metabolic function for endocrine tissues, barrier properties for gut or lung tissues, or electrophysiological activity for neural tissues). The longer-range vision described in the announcement was commercialization and broader adoption: NIH anticipated that successful projects could lead to standardized 3D cellular modules that might later be combined into more integrated organ-system platforms, enabling faster and higher-fidelity screening for drug safety and efficacy than existing approaches.
The FOA made clear what would not be supported. Projects focused on producing 3D tissues intended for transplantation were considered nonresponsive, as were efforts to engineer non-human tissue models. Also nonresponsive were "simple" 3D models that did not substantially advance beyond what was already widely available and in routine use at the time. In other words, the program was aiming for a step-change in capability, not incremental variations on standard spheroids or basic scaffold cultures without meaningful increases in physiological relevance, complexity, or functional validation.
From a disease relevance standpoint, the announcement highlighted strong interest in microphysiological models that mirror human disease pathology. Examples listed included cardiomyopathy; endocrine disorders; type 1 and type 2 diabetes; inflammatory bowel disease; pancreatitis; autoimmunity; fibrosis; muscular dystrophies; neuromuscular disorders; neurodevelopmental disorders; seizures; pulmonary hypertension; and cystic fibrosis. This emphasis signaled that the program valued models capable of reflecting not just healthy organ function but also disease-specific phenotypes that could be used to understand mechanisms and evaluate potential interventions.
Administratively, the awards were made using the U18 cooperative agreement mechanism, meaning NIH expected substantial programmatic involvement compared with a standard grant. The projects were structured as two-year awards intended to support development work demonstrating the cellular diversity, genomic complexity, architecture, and functional characteristics of the modeled tissues or organs. The total estimated funding listed was $2,000,000, with an award ceiling of $250,000. The opportunity did not require cost sharing or matching funds. The eligible applicants field lists small businesses, with additional eligibility notes referenced in the source text.
The FOA also stood out for its coordination across agencies. NIH indicated collaboration with the Defense Advanced Research Projects Agency (DARPA) and the US Food and Drug Administration (FDA) to align separate but parallel efforts in developing in vitro microphysiological systems, particularly where they intersect with regulatory science. This reflects an intent to steer model development toward platforms that could ultimately inform decision-making around therapeutic safety and efficacy, potentially easing translation from research tools into more standardized, regulator-relevant testing systems.
Key dates provided in the source include a posted and created date of November 23, 2011, with an original and current closing date of January 26, 2012, and an archive date of February 26, 2012. The program was released under CFDA 93.310 (Trans-NIH Research Support). The full announcement was linked through the NIH grants site at the time via the provided URL.
Frequently Asked Questions (FAQs)
What is the title and identifier of this NIH funding opportunity?
The funding opportunity is titled "Stem/Progenitor Cell Derived Human Micro-organs and Tissues (U18)" and is identified as RFA-RM-12-001.
What is the main goal of this funding opportunity?
The goal is to build advanced, human, multi-cellular in vitro models that reproduce meaningful aspects of real human organ physiology. The program specifically aimed to move beyond basic 3D culture systems toward stem/progenitor cell-derived micro-organs or tissue modules that capture key biological features of living organs.
What kinds of models was NIH looking for under this FOA?
NIH sought micro-organs or micro-tissues derived from stem or progenitor cells that include multiple interacting cell types, appropriate tissue architecture, and measurable, repeatable functional outputs under normal (physiological) conditions.
How is this different from standard 3D culture models?
This FOA emphasized a step-change beyond routine 3D systems. Projects needed to substantially advance physiological relevance, complexity, and functional validation beyond commonly available approaches at the time (for example, not just incremental variations on typical spheroids or basic scaffold cultures).
What biological features were applicants expected to demonstrate?
Projects were expected to demonstrate cellular diversity, genomic complexity, tissue architecture, and functional characteristics that resemble real human organs. The FOA also emphasized the importance of being able to monitor and control interactions such as cell-to-cell, cell-to-matrix, and microenvironmental effects that shape tissue behavior.
What does NIH mean by "reproducible" in this context?
Reproducibility in this FOA focused on showing consistent cellular signatures (such as stable marker profiles and gene expression patterns) and reliable functional readouts that are relevant to the organ being modeled.
What are examples of functional readouts NIH expected?
The FOA gave organ-relevant examples, including contractility for cardiac tissues, secretion and metabolic function for endocrine tissues, barrier properties for gut or lung tissues, and electrophysiological activity for neural tissues.
Why was reproducibility and functional validation such a major emphasis?
The models were expected to be useful platforms for testing therapies. NIH highlighted the need for biologically credible, repeatable systems that could support testing for drug safety and efficacy more effectively than existing approaches.
Were disease-focused models encouraged?
Yes. The FOA highlighted strong interest in microphysiological models that mirror human disease pathology, not only healthy organ function.
What disease areas were specifically highlighted as examples of interest?
Examples listed included cardiomyopathy; endocrine disorders; type 1 and type 2 diabetes; inflammatory bowel disease; pancreatitis; autoimmunity; fibrosis; muscular dystrophies; neuromuscular disorders; neurodevelopmental disorders; seizures; pulmonary hypertension; and cystic fibrosis.
What types of projects were explicitly not supported (nonresponsive)?
The FOA stated that projects focused on producing 3D tissues intended for transplantation were nonresponsive. Efforts to engineer non-human tissue models were also nonresponsive. In addition, "simple" 3D models that did not substantially advance beyond widely available, routine approaches at the time were considered nonresponsive.
Is this funding meant to support tissue engineering for transplantation?
No. The FOA explicitly indicated that projects intended to produce 3D tissues for transplantation were considered nonresponsive.
Are non-human tissue models allowed?
No. The FOA indicated that efforts to engineer non-human tissue models were nonresponsive.
What is the longer-range vision NIH described for successful projects?
The FOA described a longer-range vision that includes commercialization and broader adoption. NIH anticipated that successful projects could lead to standardized 3D cellular modules that might later be combined into more integrated organ-system platforms, supporting faster and higher-fidelity screening for drug safety and efficacy.
What funding mechanism was used for this opportunity?
Awards were made using the U18 cooperative agreement mechanism.
What does the U18 cooperative agreement imply about NIH involvement?
The FOA noted that U18 is a cooperative agreement mechanism, meaning NIH expected substantial programmatic involvement compared with a standard grant.
How long were the awards intended to last?
The projects were structured as two-year awards intended to support development work demonstrating key attributes of the modeled tissues or organs.
What was the total estimated funding and the maximum award amount?
The total estimated funding listed was $2,000,000, and the award ceiling was $250,000.
Was cost sharing or matching funds required?
No. The opportunity did not require cost sharing or matching funds.
Who was eligible to apply based on the information provided?
The eligible applicants field lists small businesses, with additional eligibility notes referenced in the source text.
Which agencies were mentioned as coordinating or collaborating around this effort?
NIH indicated collaboration with the Defense Advanced Research Projects Agency (DARPA) and the US Food and Drug Administration (FDA) to align separate but parallel efforts in developing in vitro microphysiological systems, including intersections with regulatory science.
Why was coordination with FDA and DARPA mentioned?
The FOA connected this coordination to aligning model development with microphysiological systems efforts and to supporting platforms that could ultimately inform decision-making around therapeutic safety and efficacy, potentially helping move tools toward more standardized, regulator-relevant testing systems.
What were the key dates for this funding opportunity?
The posted and created date was November 23, 2011. The original and current closing date was January 26, 2012. The archive date was February 26, 2012.
What CFDA number was associated with this program?
The program was released under CFDA 93.310 (Trans-NIH Research Support).
Where was the full announcement available?
The full announcement was linked through the NIH grants website at the time via the provided URL in the source.
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