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Phase I/II Randomized, Prospective, Double-blinded, Sham-controlled Cross-over Study of Intravitreal Autologous Bone Marrow CD34+ Stem Cell Therapy for Retinal Vein Occlusion

Award Number: UG1EY028517
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/15/2018
PERIOD OF PERFORMANCE END DATE: 05/31/2026

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Phase I/II Randomized, Prospective, Double-blinded, Sham-controlled Cross-over Study of Intravitreal Autologous Bone Marrow CD34+ Stem Cell Therapy for Retinal Vein Occlusion - PROJECT ABSTRACT The CD34RVO trial is a phase I/II randomized, prospective, double-masked, sham-controlled study with cross- over to determine the feasibility, safety and potential efficacy of intravitreal injection of autologous adult CD34+ cells from bone marrow in subjects with vision loss from retinal vein occlusion. The Emmes Corporation will serve as the Data Coordinating Center (DCC) for the CD34RVO study. In collaboration with the Study Chair, the DCC provides overall study leadership to CD34RVO mainly in areas of data management, statistical and operational support to include: statistical leadership in the study design; interim safety and study data reports to the Data and Safety Monitoring Committee; preparation of study results in collaboration with other study leadership and dissemination of findings; design and implementation of a web-based data collection system; support of the Clinical Center from study initiation to study closeout, including site monitoring to ensure proper conduct of the study and good quality data; provision of quality assurance and quality control oversight, and provision of administrative and meeting support.


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: 2025 ( Subtotal = $0 )
2025	2022	THE EMMES COMPANY LLC	401 N WASHINGTON ST, STE 700	ROCKVILLE	MD	20850	MONTGOMERY	USA	Vision Research	001	5	4/10/2025	NON-COMPETING CONTINUATION	$0
2025	2022	THE EMMES COMPANY, LLC	401 N WASHINGTON ST, STE 700	ROCKVILLE	MD	20850	MONTGOMERY	USA	Vision Research	002	5	7/28/2025	NON-COMPETING CONTINUATION	$0
2025	2022	THE EMMES COMPANY LLC	401 N WASHINGTON ST, STE 700	ROCKVILLE	MD	20850	MONTGOMERY	USA	Vision Research	000	5	3/21/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	THE EMMES COMPANY LLC	401 N WASHINGTON ST, STE 700	ROCKVILLE	MD	20850	MONTGOMERY	USA	Vision Research	000	5	2/23/2024	NON-COMPETING CONTINUATION	$0
2024	2022	THE EMMES COMPANY LLC	401 N WASHINGTON ST, STE 700	ROCKVILLE	MD	20850	MONTGOMERY	USA	Vision Research	001	5	8/21/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	THE EMMES COMPANY LLC	401 N WASHINGTON ST, STE 700	ROCKVILLE	MD	20850	MONTGOMERY	USA	Vision Research	000	5	8/21/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $315,485 )
2022	2022	THE EMMES COMPANY LLC	401 N WASHINGTON ST STE 700	ROCKVILLE	MD	20850	MONTGOMERY	USA	Vision Research	000	5	8/29/2022	NON-COMPETING CONTINUATION	$315,485
														Subtotal = $315,485

Issue Date FY: 2021 ( Subtotal = $283,361 )
2021	2021	EMMES COMPANY, LLC, THE	401 N WASHINGTON ST STE 700	ROCKVILLE	MD	20850	MONTGOMERY	USA	Vision Research	001	4	5/20/2021	NON-COMPETING CONTINUATION	$283,361
2021	2020	EMMES COMPANY, LLC, THE	401 N WASHINGTON ST STE 700	ROCKVILLE	MD	20850	MONTGOMERY	USA	Vision Research	000	3	4/6/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $283,361

Issue Date FY: 2020 ( Subtotal = $431,909 )
2020	2020	EMMES COMPANY, LLC, THE	401 N WASHINGTON ST STE 700	ROCKVILLE	MD	20850	MONTGOMERY	USA	Vision Research	000	3	6/1/2020	NON-COMPETING CONTINUATION	$431,909
														Subtotal = $431,909

Issue Date FY: 2019 ( Subtotal = $433,262 )
2019	2019	EMMES COMPANY, LLC, THE	401 N WASHINGTON ST STE 700	ROCKVILLE	MD	20850	MONTGOMERY	USA	Vision Research	001	2	7/26/2019	NON-COMPETING CONTINUATION	$433,262
2019	2018	EMMES COMPANY, LLC, THE	401 N WASHINGTON ST STE 700	ROCKVILLE	MD	20850	MONTGOMERY	USA	Vision Research	000	1	5/24/2019	NEW	$0
														Subtotal = $433,262

Issue Date FY: 2018 ( Subtotal = $474,723 )
2018	2018	EMMES CORPORATION, THE	401 N WASHINGTON ST STE 700	ROCKVILLE	MD	20850	MONTGOMERY	USA	Vision Research	000	1	6/13/2018	NEW	$474,723
														Subtotal = $474,723

Grand Total All Awards = $1,938,740

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Phase I/II Randomized, Prospective, Double-blinded, Sham-controlled Cross-over Study of Intravitreal Autologous Bone Marrow CD34+ Stem Cell Therapy for Retinal Vein Occlusion

Award Number: UG1EY028517

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 06/15/2018

PERIOD OF PERFORMANCE END DATE: 05/31/2026

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