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A Phase II Controlled Trial of Allogeneic Mesenchymal Stromal Cells for the Treatment of Refractory Lupus (MiSLE)

Award Number: U01AI184159
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2024
PERIOD OF PERFORMANCE END DATE: 05/31/2027

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A Phase II Controlled Trial of Allogeneic Mesenchymal Stromal Cells for the Treatment of Refractory Lupus (MiSLE) - Abstract Cellular therapies for the treatment of autoimmune diseases offers a novel treatment option with possible increased efficacy and decreased toxicity. We are performing the first multi-center double blind placebo controlled dose escalation trial of mesenchymal stromal cells (MSCs) for standard of care refractory lupus. This Phase II trial is based on promising data from open label trials in China and our own Phase I trial. Response rates very from 65-75% in reports from China while we saw an SRI-4 response in 5/6 patients we treated with umbilical cord derived MSCs. There are nine US centers participating in the MiSLE trial. Due to impact of the COVID-19 pandemic, we were unable to reach our goal of 81 patients during a previously funded NIAID U01 grant that expired in March, 2023. Sixty two of the 81 patients are either randomized or treated as of now. We were meeting our benchmarks of 1.98 patients per month until a COVID induced shutdown the trial for months. We are recruiting patients at this rate again. In the trial to this point, we have had no safety signals, no issues with infrastructure and patients meeting the primary study endpoint of the SRI-4. This is a critical trial to finish to definitely show if there is a treatment effect of MSCs in lupus and to delineate the mechanisms by which MSCs impact disease. In the Phase I trial we found marked impacts on extra follicular derived B cells. We are seeing similar trends in preliminary analysis of the Phase II trial, though we are blinded as to treatment group. We have introduced novel methods of multi-parameter statistical analysis to enhance detecting a treatment effect. In mechanistic studies we will complete the analyses of B and T cell subsets, receptor diversity and epigenetics over the course of the trial. Based on the development of new technology, we will perform CyTOF on mononuclear cell populations, Cite Seq single cell analysis and plasma microbiome assays. These assays will be performed at weeks 0, 4, 8 and 24. We have sufficient stored samples to perform the proposed assays. This highly impactful trial will provide important insight into changes over time of key immune mediators of lupus, perhaps allowing pre-treatment identification of patients most likely to respond to MSC treatment.


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 = $1,459,720 )
2025	2025	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Allergy and Infectious Diseases Research	001	2	5/22/2025	NON-COMPETING CONTINUATION	$1,459,720
2025	2024	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Allergy and Infectious Diseases Research	000	1	11/12/2024	NEW	$0
														Subtotal = $1,459,720

Issue Date FY: 2024 ( Subtotal = $1,225,013 )
2024	2024	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Allergy and Infectious Diseases Research	000	1	8/1/2024	NEW	$1,225,013
														Subtotal = $1,225,013

Grand Total All Awards = $2,684,733

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A Phase II Controlled Trial of Allogeneic Mesenchymal Stromal Cells for the Treatment of Refractory Lupus (MiSLE)

Award Number: U01AI184159

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 08/01/2024

PERIOD OF PERFORMANCE END DATE: 05/31/2027

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