Treatment of fistula with bone marrow mesenchymal stem cell derived extracellular vesicles
Inventors
MOSELEY, Timothy Alexander • Pettine, Kenneth Allen
Assignees
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Publication Number
US-12502407-B2
Publication Date
2025-12-23
Expiration Date
Abstract
Disclosed are methods of treating perianal fistula a subject by administering a therapeutic MSC secretome product made by a method comprising culturing bone marrow-derived MSCs under conditions that include oxygen tension below 5% and a culture media with a pH below 7.
Core Innovation
The disclosed invention relates to a method of treating perianal fistula in a subject having ulcerative colitis or Crohn's disease by administering a therapeutic bone marrow mesenchymal stem cell (MSC) secretome composition comprising extracellular vesicles. In the therapeutic composition, at least 80% of the extracellular vesicles are CD63+ CD9− CD81−, defining an extracellular vesicle phenotype. The secretome composition contains therapeutic cargo, including proteins and nucleic acids.
The therapeutic bone marrow MSC secretome composition is produced as a secretome derived from bone marrow-derived MSCs. The production method includes culturing bone marrow-derived MSCs under conditions including oxygen tension below 5% and culture media having a pH below 7, harvesting bone marrow MSC conditioned media, and formulating the conditioned media to produce the therapeutic bone marrow MSC secretome composition.
The composition comprises proteins and extracellular vesicles produced by the bone marrow-derived MSCs in the culturing step. The document also references evaluation in studies for Crohn's disease-associated perianal fistulizing disease and for cryptoglandular perianal fistula using an allogeneic hBM-MSC EV isolate product.
Claims Coverage
The independent claims cover three core inventive areas: treatment of perianal fistula in ulcerative colitis or Crohn's disease with a bone marrow MSC secretome having a defined extracellular vesicle marker phenotype; treatment of perianal fistula with a bone marrow MSC secretome composition containing VEGF, TIMP1, and IGFBP4; and treatment of perianal fistula with a therapeutic bone marrow MSC secretome composition produced by culturing bone marrow-derived MSCs under oxygen tension below 5% and culture media pH below 7, then harvesting and formulating conditioned media.
Treating perianal fistula with CD63+ CD9− CD81− MSC secretome extracellular vesicles
A method of treating perianal fistula in a subject having ulcerative colitis or Crohn's disease by administering a therapeutic bone marrow MSC secretome composition comprising extracellular vesicles, wherein at least 80% of the extracellular vesicles are CD63+ CD9− CD81−.
MSC secretome composition including VEGF, TIMP1, and IGFBP4
A method of treating perianal fistula in a subject in need thereof by administering a therapeutic bone marrow MSC secretome composition comprising extracellular vesicles, wherein the therapeutic bone marrow MSC secretome composition comprises VEGF, TIMP1, and IGFBP4.
Secretome produced under oxygen tension below 5% and culture media pH below 7
A method of treating perianal fistula in a subject having Crohn's disease or ulcerative colitis by administering a composition comprising a therapeutic bone marrow MSC secretome composition made by culturing bone marrow-derived MSCs under oxygen tension below 5% and culture media having a pH below 7, harvesting the bone marrow MSC conditioned media, and formulating the conditioned media to produce the therapeutic bone marrow MSC secretome composition comprising proteins and extracellular vesicles produced by the bone marrow-derived MSCs.
Across the independent claims, the therapeutic approach is based on administering a bone marrow MSC secretome containing extracellular vesicles, with key definitional constraints including an extracellular vesicle marker phenotype (CD63+ CD9− CD81−), specified secretome cargo constituents (VEGF, TIMP1, and IGFBP4), and a production method using oxygen tension below 5% and culture media pH below 7.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Studying treatment of Crohn's disease-associated perianal fistulizing disease using an allogeneic hBM-MSC EV isolate product (ExoFlo).
Studying cryptoglandular perianal fistula using the described allogeneic hBM-MSC EV isolate product (ExoFlo).
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