Treatment of inflammatory bowel disease with long acting glatiramer and adipose-derived stem cells
Inventors
Marom, Ehud • BLEICH KIMELMAN, Nadav • Grynspan, Frida
Assignees
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Publication Number
US-12161688-B2
Publication Date
2024-12-10
Expiration Date
Abstract
Methods for treating inflammatory bowel disease are provided, comprising administration of glatiramer acetate in a sustained-release depot form and administration of adipose-derived stem cells.
Core Innovation
The document describes a combination therapy for inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, using glatiramer acetate in a long-acting sustained-release depot form together with human adipose-derived stem cells. The glatiramer acetate is provided in a PLGA-based injectable depot, including PLGA-based microparticles formed by water-in-oil-in-water double emulsification depot formulations and other sustained-release depot forms described in the document.
The approach is described as administering the combination to reduce severity of IBD-related symptoms. The problem addressed in the background is the need to reduce severity of ulcerative colitis symptoms, specifically including rectal bleeding, colon length shortening, and colonic histological changes.
The document reports results in a mouse DSS-induced IBD study showing improved outcomes compared with either treatment alone, including rectal bleeding, colon shortening, daily activity index, and histological score. It also describes that hADSCs are characterized by immunophenotyping markers including CD44/CD73/CD90 positivity and CD105 positivity, with negativity for CD45/CD19/CD11B/HLADR, and optional CD34 positivity.
Claims Coverage
The partial content includes two independent claims directed to reducing ulcerative colitis symptom severity and delivering the stated combination to a subject in need. Across the independent claims, the main inventive features are the specific combination format and the defined co-administration with hADSCs, including the intended symptom scope.
Plga-based sustained-release injectable depot of glatiramer acetate co-administered with hADSCs
A method of reducing severity of one or more ulcerative colitis symptoms in a subject by administering a combination of a pharmaceutical composition comprising glatiramer acetate in a sustained release depot form, wherein the sustained-release depot form is a poly (D,L-lactide-co-glycolide) (PLGA)-based injectable depot, together with human adipose-derived stem cells (hADSCs).
Delivery to subjects at risk of or experiencing rectal bleeding and/or colon shortening
A method of delivering a combination of PLGA-based injectable depot glatiramer acetate and hADSCs to a subject in need thereof, wherein the subject is at risk of rectal bleeding and colon shortening, or experiencing rectal bleeding and/or colon shortening.
Both independent claims focus on administering a defined combination of PLGA-based sustained-release injectable depot glatiramer acetate together with human adipose-derived stem cells to reduce ulcerative colitis symptom severity, including rectal bleeding and colon shortening.
Stated Advantages
Reduces severity of ulcerative colitis symptoms, including rectal bleeding, colon length shortening and colonic histological changes, in a subject receiving the combination.
Demonstrates synergistic reduction in reported measures in a mouse DSS-induced IBD study versus either treatment alone, including rectal bleeding, colon shortening, daily activity index, and histological score.
Documented Applications
Treatment/reduction of severity of ulcerative colitis symptoms in a subject, including rectal bleeding, colon length shortening, and colonic histological changes.
Delivery to a subject in need that is at risk of rectal bleeding and colon shortening, or experiencing rectal bleeding and/or colon shortening.
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