Compositions comprising nanoparticles, method of making and uses thereof
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Publication Number
US-12377121-B2
Publication Date
2025-08-05
Expiration Date
Abstract
Presented herein, in certain aspects, are cell-free therapeutic composition derived from human amniotic fluid (HAF) and uses thereof for the prevention and treatment of selected diseases and disorders.
Core Innovation
A therapeutic composition is described that comprises a modified human amniotic fluid (HAF) and HAF-derived nanoparticles. The modified HAF comprises particles having a particulate size of less than about 200 nm and the composition is substantially free of cells, lanugo, and vernix. The HAF-derived nanoparticles are selected from exosomes, surface-bound proteins, and microRNAs (miRNAs).
Each HAF-derived nanoparticle has a diameter greater than about 30 nm, and the concentration of particles in the composition is at least about 1×10^8 particles/ml in the therapeutic composition. The described compositions include soluble factors such as hyaluronic acid and selected cytokines and growth factors, and include extensive characterization of nanoparticle/exosome size and concentration and cargo (protein and miRNA).
The document describes that the characterized HAF-derived nanoparticles and exosomes include exosome markers CD63, CD81, and CD9 and surface markers including CD133 and CD326, along with protein cargo and miRNA cargo identification. It also reports documented in vivo and clinical use cases, including rat bronchopulmonary dysplasia models and osteoarthritis assessment with WOMAC improvements, and compassionate-use COVID-19 cases with improved SOFA scores and changes in inflammatory biomarkers after administration of the claimed composition.
Claims Coverage
The document includes two independent claims covering therapeutic and pharmaceutical compositions based on modified human amniotic fluid (HAF) and HAF-derived nanoparticles. Each independent claim contains multiple inventive composition-defining features, including particulate size constraints, specific nanoparticle classes, substantial freedom from cells/lanugo/vernix, nanoparticle diameter constraints, and defined particle concentration thresholds, with the pharmaceutical claim further requiring pharmaceutically acceptable ingredients and excipients/additives.
Modified human amniotic fluid particles below 200 nm
A therapeutic composition comprising a modified human amniotic fluid (HAF), the modified HAF comprising particles having a particulate size of less than about 200 nm.
HAF-derived nanoparticles selected from exosomes, surface-bound proteins, and microRNAs
HAF-derived nanoparticles selected from a list of nanoparticles consisting of exosomes, surface-bound proteins, and microRNAs (miRNAs).
Substantially free of cells, lanugo, and vernix
Wherein said composition is substantially free of cells, lanugo, and vernix.
Nanoparticle diameter greater than 30 nm
Wherein each of the HAF-derived nanoparticles has a diameter greater than about 30 nm.
Particle concentration at least 1×10^8 particles/ml
Wherein the concentration of particles in said composition is at least about 1×10^8 particles/ml.
Pharmaceutical composition with pharmaceutically acceptable ingredients
A pharmaceutical composition comprising (iii) one or more pharmaceutically acceptable ingredients, the one or more pharmaceutically acceptable ingredients comprising excipients and additives.
Particle concentration at least 1×10^9 particles/ml for pharmaceutical composition
Wherein the concentration of particles in said composition is at least about 1×10^9 particles/ml.
Overall, the independent claims define compositions using modified HAF with sub-200 nm particulate size, substantially excluding cells/lanugo/vernix, and incorporating HAF-derived nanoparticles of exosomes/surface-bound proteins/miRNAs with nanoparticle diameter greater than about 30 nm and specified particle concentration thresholds (at least about 1×10^8 particles/ml for the therapeutic composition and at least about 1×10^9 particles/ml for the pharmaceutical composition), with the pharmaceutical claim additionally requiring pharmaceutically acceptable ingredients comprising excipients and additives.
Stated Advantages
Improved survival and reduced pulmonary hypertension and muscularization in a rat bronchopulmonary dysplasia hyperoxia study after administration of Organicell Flow-XL.
Reduced macrophage infiltration in the rat bronchopulmonary dysplasia hyperoxia study after administration of Organicell Flow-XL.
Improved WOMAC outcomes in an osteoarthritis study after an intravenous infusion.
Improved SOFA scores in compassionate-use COVID-19 cases after administration of Organicell Flow.
Improved respiratory status and imaging findings in compassionate-use COVID-19 cases after administration of Organicell Flow.
Changes in inflammatory biomarkers (including D-dimer, CRP, IL-6, and TNFα) in compassionate-use COVID-19 cases after administration of Organicell Flow.
Documented Applications
Rat bronchopulmonary dysplasia hyperoxia study using Organicell Flow-XL, reporting improved survival and reduced pulmonary hypertension/muscularization and reduced macrophage infiltration.
Osteoarthritis study reporting WOMAC improvements after an intravenous infusion.
Compassionate-use COVID-19 cases using Organicell Flow, reporting improved SOFA score, respiratory status, imaging findings, and trends in inflammatory biomarkers.
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