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Complex 3-Dimensional in vitro Human Skin Tissue Models for Scleroderma

Award Number: R44AR072170
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/14/2018
PERIOD OF PERFORMANCE END DATE: 08/31/2021

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Complex 3-Dimensional in vitro Human Skin Tissue Models for Scleroderma - PROJECT SUMMARY Scleroderma (systemic sclerosis; SSc) is an autoimmune disease of unknown etiology that is characterized by vascular dysfunction, fibrosis, and inflammation. One in three patients dies within 10 years of diagnosis, giving SSc the highest case fatality rate of any systemic autoimmune disease. A lack of biologically-relevant SSc disease models has created a critical unmet need for more efficient preclinical drug screening models that can provide faster, more cost-effective ways of predicting the success or failure of drugs designed to treat SSc. Recent advances in tissue engineering have resulted in 3-D skin tissue-based disease models that can closely mimic SSc in humans. This advancement will shorten the preclinical drug development timeline, save animal lives, increase drug success rates, and inform FDA decision-making for the development of new and effective disease therapeutics. In phase-I SBIR work, the Celdara Medical research team developed 3-D skin-like tissue models that accurately recapitulate the SSc phenotype and are an important advancement over the currently available monolayer, 2-D tissue cultures. Phase-II work is now proposed to develop this into a commercial, pre- clinical drug screening platform, named SclerEx. By developing 3-D skin models at Celdara, this promising in vitro system can now be paired with Celdara’s existing portfolio of SSc diagnostics and SSc, fibrosis, and cancer drug development efforts. It can also be provided to Celdara’s pharma partners for pre-clinical drug testing of anti-fibrotic compounds that exist in their development pipelines. This work will leverage SclerEx skin-like models for drug screening, which will advance complex tissue models for other organ systems, such as lung and esophagus. By using multiple, patient-derived cell types to optimize 3-D tissues to establish robust, SSc-specific, 3-D tissue models that can serve as preclinical drug screening platforms for new therapeutic agents for SSc, this project will advance the identification of anti-fibrotic therapies. The aims of the work proposed are to: (1) evaluate the reproducibility of the previously optimized 3-D tissue model for SSc by performing assay validation and consistent benchmark measures that are reproducible and reliable; (2) demonstrate and evaluate the utility of the model for drug screening by performing proof-of-concept screening using known SSc therapies and therapies currently in clinical trials; and (3) identify and control for the circulating factor(s) in plasma/sera that result in increased skin thickness and/or impact monocyte differentiation by Luminex assays or high-throughput protein screening, so it will generate a highly reproducible 3-D tissue model system.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = -$9,174 )
2023	2019	CELDARA MEDICAL	16 CAVENDISH CT	LEBANON	NH	03766	GRAFTON	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	2/2/2023	NON-COMPETING CONTINUATION	-$9,174
														Subtotal = -$9,174

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2019	CELDARA MEDICAL, LLC	16 CAVENDISH CT	LEBANON	NH	03766	GRAFTON	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	2/18/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	CELDARA MEDICAL, LLC	16 CAVENDISH CT	LEBANON	NH	03766	GRAFTON	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	4/6/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	CELDARA MEDICAL, LLC	16 CAVENDISH CT	LEBANON	NH	03766	GRAFTON	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	3	5/19/2020	NON-COMPETING CONTINUATION	$0
2020	2019	CELDARA MEDICAL, LLC	16 CAVENDISH CT	LEBANON	NH	03766	GRAFTON	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	12/17/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $747,276 )
2019	2019	CELDARA MEDICAL, LLC	16 CAVENDISH CT	LEBANON	NH	03766	GRAFTON	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	3	9/16/2019	NON-COMPETING CONTINUATION	$738,102
2019	2018	CELDARA MEDICAL, LLC	16 CAVENDISH CT	LEBANON	NH	03766	GRAFTON	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	2/1/2019	COMPETING CONTINUATION	$9,174
														Subtotal = $747,276

Issue Date FY: 2018 ( Subtotal = $749,999 )
2018	2018	CELDARA MEDICAL, LLC	16 CAVENDISH CT	LEBANON	NH	03766	GRAFTON	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	9/14/2018	COMPETING CONTINUATION	$749,999
														Subtotal = $749,999

Grand Total All Awards = $1,488,101

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Complex 3-Dimensional in vitro Human Skin Tissue Models for Scleroderma

Award Number: R44AR072170

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/14/2018

PERIOD OF PERFORMANCE END DATE: 08/31/2021

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