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Biomarkers for Therapy of FSHD (U54)

Award Number: U54HD060848
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/10/2008
PERIOD OF PERFORMANCE END DATE: 08/31/2013

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Biomarkers for Therapy of FSHD (U54) - A multi-center team proposes to establish a Wellstone Cooperating Research Center focused on identifying biomarkers to evaluate outcomes of clinical trials for facioscapulohumeral muscular dystrophy (FSHD). In Project 1, Dr. K. Wagner (Johns Hopkins Med Sen) will lead a Phase I clinical trial with Acceleron to assess the effects of its myostatin inhibitor, ACE-031, on healthy human subjects, preparatory to assessing its use in FSHD. In Project 2, Drs. L.M. Kunkel (Harvard Med Sch), M. Zatz (U Sao Paolo), and R.J. Bloch (U Maryland Sch Med) will use biopsy samples to identify changes in RNAs and proteins in FSHD, with the aims of identifying additional disease biomarkers and learning how they are altered in healthy human muscle upon myostatin blockade. Project 3, led by Drs. C.P. Emerson Jr. (Boston Biomedical Research Institute: BBRI) and W. Wright (U Texas Southwestern Medical Center), will derive primary and immortal myogenic cell lines from FSHD and normal biopsies to identify biomarkers and examine their role in proliferation, differentiation, and pathogenesis of muscle cells. Project 4, led by Dr. J.B. Miller (BBRI) in collaboration with Dr. Bloch, will use mouse models and cultured human cells to analyze FSHD biomarkers and identify disease mechanisms. The Cell and Tissue Core (Core C) will work with collaborating physicians to collect and curate muscle biopsies from FSHD patients and healthy volunteers. The Core will also be an international resource to maintain and distribute FSHD and normal myogenic cell lines developed in the Center. An Administrative Core (Core A) led by Dr. Emerson will organize regular meetings among the project scientists and will work with Mr. D. Perez (The FSH Society) for community outreach and to organize an annual open scientific meeting on FSHD. Core A will coordinate this activity with the Education and Training Core (Core B), led by Dr. Bloch, which will support two trainees/yr and will organize an annual Center retreat. The Center's research, core, and training activities are thus aimed at identifying and testing FSHD biomarkers for development of new therapies, providing novel reagents for FSHD researchers worldwide, assessing myostatin inhibitors as a potential FSHD therapeutic, and structuring an outstanding environment for training young scientists. Relevance to Public Health. The proposed Wellstone Center will identify biomarkers for FSHD that can be used for evaluating outcomes in clinical trials.


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: 2019 ( Subtotal = -$30,166 )
2019	2017	UNIVERSITY OF MASSACHUSETTS	55 LAKE AVE NORTH	WORCESTER	MA	01655	WORCESTER	USA	Child Health and Human Development Extramural Research	000	11	1/25/2019	NON-COMPETING CONTINUATION	-$30,166
														Subtotal = -$30,166

Issue Date FY: 2018 ( Subtotal = $0 )
2018	2017	UNIVERSITY OF MASSACHUSETTS	55 LAKE AVE N	WORCESTER	MA	01655	WORCESTER	USA	Child Health and Human Development Extramural Research	000	11	9/13/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $1,387,935 )
2017	2017	UNIVERSITY OF MASSACHUSETTS	55 LAKE AVE N	WORCESTER	MA	01655	WORCESTER	USA	Child Health and Human Development Extramural Research	002	11	7/3/2017	NON-COMPETING CONTINUATION	$1,387,935
2017	2016	UNIVERSITY OF MASSACHUSETTS	55 LAKE AVE N	WORCESTER	MA	01655	WORCESTER	USA	Child Health and Human Development Extramural Research	001	10	11/14/2016	EXTENSION WITH OR WITHOUT FUNDS	$310,813
2017	2015	UNIVERSITY OF MASSACHUSETTS	55 LAKE AVE N	WORCESTER	MA	01655	WORCESTER	USA	Child Health and Human Development Extramural Research	000	9	11/14/2016	NON-COMPETING CONTINUATION	-$310,813
														Subtotal = $1,387,935

Issue Date FY: 2016 ( Subtotal = $1,376,163 )
2016	2016	UNIVERSITY OF MASSACHUSETTS	406 GOODELL BLDG, BOX 33210	AMHERST	MA	01003	HAMPSHIRE	USA	Child Health and Human Development Extramural Research	000	10	6/20/2016	EXTENSION WITH OR WITHOUT FUNDS	$1,376,163
														Subtotal = $1,376,163

Issue Date FY: 2015 ( Subtotal = $1,392,508 )
2015	2015	UNIVERSITY OF MASSACHUSETTS	406 GOODELL BLDG, BOX 33210	AMHERST	MA	01003	HAMPSHIRE	USA	Child Health and Human Development Extramural Research	000	9	5/21/2015	NON-COMPETING CONTINUATION	$1,392,508
														Subtotal = $1,392,508

Issue Date FY: 2014 ( Subtotal = $1,363,623 )
2014	2014	UNIVERSITY OF MASSACHUSETTS	406 GOODELL BLDG, BOX 33210	AMHERST	MA	01003	HAMPSHIRE	USA	Child Health and Human Development Extramural Research	000	8	6/27/2014	NON-COMPETING CONTINUATION	$1,363,623
														Subtotal = $1,363,623

Issue Date FY: 2013 ( Subtotal = $1,500,000 )
2013	2013	UNIVERSITY OF MASSACHUSETTS	406 GOODELL BLDG, BOX 33210	AMHERST	MA	01003	HAMPSHIRE	USA	Child Health and Human Development Extramural Research	002	7	9/13/2013	COMPETING CONTINUATION	$1,500,000
2013	2012	BOSTON BIOMEDICAL RESEARCH INSTITUTE	64 GROVE STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Child Health and Human Development Extramural Research	001	5	7/22/2013	NON-COMPETING CONTINUATION	-$1,086,205
2013	2012	UNIVERSITY OF MASSACHUSETTS	406 GOODELL BLDG, BOX 33210	AMHERST	MA	01003	HAMPSHIRE	USA	Child Health and Human Development Extramural Research	000	6	7/22/2013	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,086,205
														Subtotal = $1,500,000

Issue Date FY: 2012 ( Subtotal = $1,737,284 )
2012	2012	BOSTON BIOMEDICAL RESEARCH INSTITUTE	64 GROVE STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Child Health and Human Development Extramural Research	000	5	8/10/2012	NON-COMPETING CONTINUATION	$1,737,284
														Subtotal = $1,737,284

Issue Date FY: 2011 ( Subtotal = $1,766,112 )
2011	2011	BOSTON BIOMEDICAL RESEARCH INSTITUTE	64 GROVE STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Child Health and Human Development Extramural Research	001	4	9/21/2011	NON-COMPETING CONTINUATION	$1,766,112
2011	2009	BOSTON BIOMEDICAL RESEARCH INSTITUTE	64 GROVE STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Trans-NIH Recovery Act Research Support	000	2	9/21/2011	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $1,766,112

Issue Date FY: 2010 ( Subtotal = $1,731,891 )
2010	2010	BOSTON BIOMEDICAL RESEARCH INSTITUTE	64 GROVE STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Child Health and Human Development Extramural Research	002	3	9/7/2010	NON-COMPETING CONTINUATION	$1,731,891
2010	2009	BOSTON BIOMEDICAL RESEARCH INSTITUTE	64 GROVE STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Child Health and Human Development Extramural Research	001	2	6/14/2010	NON-COMPETING CONTINUATION	$0
2010	2008	BOSTON BIOMEDICAL RESEARCH INSTITUTE	64 GROVE STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Child Health and Human Development Extramural Research	000	1	6/14/2010	NEW	$0
														Subtotal = $1,731,891

Issue Date FY: 2009 ( Subtotal = $2,104,462 )
2009	2009	BOSTON BIOMEDICAL RESEARCH INSTITUTE	64 GROVE STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Trans-NIH Recovery Act Research Support	003	2	9/23/2009	SUPPLEMENT FOR EXPANSION	$342,766
2009	2009	BOSTON BIOMEDICAL RESEARCH INSTITUTE	64 GROVE STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Child Health and Human Development Extramural Research	002	2	8/14/2009	NON-COMPETING CONTINUATION	$1,744,087
2009	2008	BOSTON BIOMEDICAL RESEARCH INSTITUTE	64 GROVE STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Child Health and Human Development Extramural Research	000	1	5/6/2009	NEW	$17,609
2009	2008	BOSTON BIOMEDICAL RESEARCH INSTITUTE	64 GROVE STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Child Health and Human Development Extramural Research	001	1	8/14/2009	NEW	$0
														Subtotal = $2,104,462

Issue Date FY: 2008 ( Subtotal = $1,726,476 )
2008	2008	BOSTON BIOMEDICAL RESEARCH INSTITUTE	64 GROVE STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Child Health and Human Development Extramural Research	000	1	9/5/2008	NEW	$1,726,476
														Subtotal = $1,726,476

Grand Total All Awards = $16,056,288

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Biomarkers for Therapy of FSHD (U54)

Award Number: U54HD060848

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/10/2008

PERIOD OF PERFORMANCE END DATE: 08/31/2013

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