Wednesday, August 20, 2025 8/20/2025

BMT CTN Core - Mount Sinai Consortium

Award Number: UG1HL138645
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/27/2017
PERIOD OF PERFORMANCE END DATE: 06/30/2031

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BMT CTN Core - Mount Sinai Consortium - The Mount Sinai BMT CTN Consortium (MSBCC) combines three large blood and marrow transplant (BMT) centers (Mount Sinai, Vanderbilt, and the Mayo Clinic); >950 total annual HCTs including >250 allogeneic HCTs and >100 immune effector cell therapies. The MSBCC has a strong track record of BMT CTN productivity and possesses significant strengths to accomplish BMT CTN strategic goals. In terms of scientific leadership, Dr. Levine will be Steering Committee Chair starting in 2024. The MSBCC has provided extremely strong accrual to BMT CTN clinical trials, with a proven ability to enroll large numbers of participants. It possesses extensive expertise in transplant for non-malignant blood diseases (especially sickle cell disease). Graft versus host disease (GVHD) is a high priority for the BMT CTN and the MSBCC benefits from the successful collaborations of the Mount Sinai Acute GVHD International Consortium (MAGIC) which now houses a large natural history database (>6000 patients) that has enabled a highly innovative, biomarker-based approach to this major complication of allogeneic BMT. As shown in our preliminary data, steroid-refractory (SR) acute (a) GVHD remains an unmet medical need despite the fact that it has become less common and less lethal. Nearly half of patients with SR-aGVHD do not respond to ruxolitinib and these patients have a dismal 100 day survival rate of only 20%. Remestemcel-L, a bone marrow derived mesenchymal stromal cell (MSC) product has shown significant efficacy with virtually no toxicity in treating SR-aGVHD in children and adults. Although an earlier MSC product, Prochymal, did not prove effective for adults with SR-aGVHD, its lack of potency was a major contributor to its poor efficacy. The improved quality controlled product, Ryoncil, passes a potency assay before release; is available to be tested in a clinical trial. Our proposal shows that third line treatment with this new, high potency product increases day 100 survival of patients with SR-aGVHD to greater than 60%. We thus propose a clinical trial to improve day 100 survival in patients with acute GVHD resistant to both steroids and a second line of treatment. Our proposal is supported by the manufacturer, Mesoblast. Our specific aims are: (1) To participate vigorously in BMT CTN clinical trials and committees and (2) To treat resistant GVHD with high-potency remestemcel-L to improve survival.


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 = $219,211 )
2025	2025	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	1 GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Blood Diseases and Resources Research	002	9	8/6/2025	NON-COMPETING CONTINUATION	$219,211
2025	2024	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	1 GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Blood Diseases and Resources Research	001	8	2/24/2025	COMPETING CONTINUATION	$0
2025	2023	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	1 GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Blood Diseases and Resources Research	000	7	2/24/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $219,211

Issue Date FY: 2024 ( Subtotal = $251,775 )
2024	2024	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	1 GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Blood Diseases and Resources Research	001	8	8/12/2024	COMPETING CONTINUATION	$251,775
2024	2023	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	1 GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Blood Diseases and Resources Research	000	7	7/30/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $251,775

Issue Date FY: 2023 ( Subtotal = $173,337 )
2023	2023	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Blood Diseases and Resources Research	001	7	8/23/2023	NON-COMPETING CONTINUATION	$0
2023	2023	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Blood Diseases and Resources Research	000	7	6/29/2023	NON-COMPETING CONTINUATION	$173,337
														Subtotal = $173,337

Issue Date FY: 2022 ( Subtotal = $173,337 )
2022	2022	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Blood Diseases and Resources Research	001	6	7/1/2022	NON-COMPETING CONTINUATION	$173,337
2022	2021	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Blood Diseases and Resources Research	000	5	2/3/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $173,337

Issue Date FY: 2021 ( Subtotal = $173,337 )
2021	2021	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Blood Diseases and Resources Research	000	5	6/15/2021	NON-COMPETING CONTINUATION	$173,337
														Subtotal = $173,337

Issue Date FY: 2020 ( Subtotal = $173,337 )
2020	2020	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Blood Diseases and Resources Research	000	4	5/7/2020	NON-COMPETING CONTINUATION	$173,337
														Subtotal = $173,337

Issue Date FY: 2019 ( Subtotal = $173,337 )
2019	2019	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Blood Diseases and Resources Research	000	3	5/26/2019	NON-COMPETING CONTINUATION	$173,337
														Subtotal = $173,337

Issue Date FY: 2018 ( Subtotal = $170,861 )
2018	2018	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Blood Diseases and Resources Research	000	2	6/14/2018	NON-COMPETING CONTINUATION	$170,861
														Subtotal = $170,861

Issue Date FY: 2017 ( Subtotal = $193,233 )
2017	2017	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Blood Diseases and Resources Research	001	1	8/22/2017	NEW	$0
2017	2017	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	ONE GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Blood Diseases and Resources Research	000	1	7/27/2017	NEW	$193,233
														Subtotal = $193,233

Grand Total All Awards = $1,701,765

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BMT CTN Core - Mount Sinai Consortium

Award Number: UG1HL138645

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 07/27/2017

PERIOD OF PERFORMANCE END DATE: 06/30/2031

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