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A Phase II Controlled Trial of Allogeneic Mesenchymal Stem Cells for the Treatment of Refractory Lupus

Award Number: U01AI125159
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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This a Type 4 clinical trial extension for the MSC in SLE (MiSLE) trial to determine if MSCs provide a safe and effective alternative to current therapies in lupus. The proposed extension will enable completion of the data cleaning, statistical analysis and mechanistic studies. The monetary support for patient visits and MSC preparation is provided by the Lupus Foundation of America in a relatively unique collaborative arrangement making this trial possible. The five years of NIAID support end on 03/31/2023. A No Cost Extension was granted allowing carryover of funds to continue the trial and its components while awaiting the hoped for Title 4 approval. This extension is needed to offset the delays in enrollment in the trial due to the COVID pandemic. Enrollment slowed as the pandemic began due to patient concerns for coming to a medical center. The trial was closed to enrollment in abiding by local IRB determinations. Even after re-opening enrollment was slowed by ongoing patient concerns. Over the last 3-4 months enrollment has returned to pre-COVID rates. At this time, 56/81 patients are infused with investigational product in a 2/1 ratio of MSCs versus placebo in a double blind enrollment and randomization. We propose to complete enrollment in the first 12-18 months of the extension, with completion of the data analysis and mechanistic studies by the 36 month end of the extension. All aspects of the trial including recruitment, consent, infusion, followup, data entry and biologic sample handling have met pretrial goals. We added two new sites (Feinstein and Oklahoma Medical Research Foundation) to enhance enrollment. Our current enrollment rate is 2 patients per month. The two original aims of the study remain unchanged. Aim one is to complete the multicenter double blind placebo controlled trial of MSCs in standard of care refractory lupus patients. Aim two is to perform in depth immune phenotype of the patients pre and post treatment to determine the impacts of MSC infusions on B cell, T cell and mononuclear cell phenotypes and function. This trial will provide insight into the safety and efficacy of MSC infusion in lupus either confirming the positive results in unblinded trials from China. Mechanistic studies will inform immune mechanisms of MSCs.


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	2023	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Allergy and Infectious Diseases Research	001	6	10/22/2024	EXTENSION WITH OR WITHOUT FUNDS	$357,560
2025	2022	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Allergy and Infectious Diseases Research	000	5	10/22/2024	NON-COMPETING CONTINUATION	-$357,560
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $464,370 )
2023	2023	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Allergy and Infectious Diseases Research	002	6	8/15/2023	EXTENSION WITH OR WITHOUT FUNDS	$464,370
2023	2022	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Allergy and Infectious Diseases Research	000	5	11/10/2022	NON-COMPETING CONTINUATION	$0
2023	2022	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Allergy and Infectious Diseases Research	001	5	8/3/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $464,370

Issue Date FY: 2022 ( Subtotal = $707,818 )
2022	2022	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Allergy and Infectious Diseases Research	001	5	4/4/2022	NON-COMPETING CONTINUATION	$707,818
2022	2021	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Allergy and Infectious Diseases Research	000	4	10/29/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $707,818

Issue Date FY: 2021 ( Subtotal = $707,818 )
2021	2021	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Allergy and Infectious Diseases Research	001	4	2/19/2021	NON-COMPETING CONTINUATION	$707,818
2021	2020	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Allergy and Infectious Diseases Research	000	3	12/14/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $707,818

Issue Date FY: 2020 ( Subtotal = $707,818 )
2020	2020	MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Allergy and Infectious Diseases Research	000	3	2/12/2020	NON-COMPETING CONTINUATION	$707,818
														Subtotal = $707,818

Issue Date FY: 2019 ( Subtotal = $707,818 )
2019	2019	MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Allergy and Infectious Diseases Research	000	2	2/11/2019	NON-COMPETING CONTINUATION	$707,818
2019	2019	MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Allergy and Infectious Diseases Research	001	2	9/13/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $707,818

Issue Date FY: 2018 ( Subtotal = $720,193 )
2018	2018	MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Allergy and Infectious Diseases Research	000	1	3/19/2018	NEW	$720,193
														Subtotal = $720,193

Grand Total All Awards = $4,015,835

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A Phase II Controlled Trial of Allogeneic Mesenchymal Stem Cells for the Treatment of Refractory Lupus

Award Number: U01AI125159

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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