OSSM-001 / Ossium Health - LARVOL DELTA

Tissue Distribution and Pharmacokinetics of Repeatedly Intravenously Dosed Mesenchymal Stem Cells in Severely Immunocompromised Mice (TCT-ASTCT-CIBMTR 2024) - "We conducted a biodistribution study in mice to (1) determine the total body exposure and persistence of OSSM-007 with intravenous administration at a dose of 2 million cells/mouse and (2) to determine the effects of IFNg priming by comparing to unprimed MSC (OSSM-001). Furthermore, incubation with IFNg (OSSM-007) did not appear to have a noticeable impact on the biodistribution or persistence of BM-MSC administered intravenously. Combined with contemporaneous tumorigenicity and toxicity study, these results indicate that systemic exposure of multiple OSSM-007 doses that are equivalent to 4.8 billion/60 kg patient is transient and safe."

PK/PD data • Preclinical • Acute Graft versus Host Disease • Aplastic Anemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Oncology • Transplantation • IFNG

Mesenchymal Stem Cells (MSCs) for Perianal Fistula (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Ossium Health, Inc. | N=16 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

Mesenchymal Stem Cells (MSCs) for Steroid Refractory Acute GVHD (SR-aGVHD) (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Ossium Health, Inc. | N=12 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology

Mesenchymal Stem Cells (MSCs) for Steroid Refractory Acute GVHD (SR-aGVHD) (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Ossium Health, Inc.

New P1 trial • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology

Mesenchymal Stem Cells (MSCs) for Perianal Fistula (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Ossium Health, Inc.

New P1 trial • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

Ossium Health Announces FDA Clearance of its Investigational New Drug Application for Treatment of Perianal Fistulizing Crohn’s Disease (Businesswire) - "Ossium Health, Inc...announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for OSSM-001, a mesenchymal stem cell (MSC) product, for the treatment of refractory perianal fistulas in patients with Crohn’s disease. Ossium plans to initiate patient screening and enrollment in a multi-center Phase 1 clinical trial evaluating OSSM-001 by the end of 2022."

IND • New P1 trial • Crohn's disease • Inflammatory Bowel Disease