Formulations involving solvent/detergent-treated plasma (S/D plasma) and uses thereof
Inventors
Bastianelli, Enrico • Albarani, Valentina
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11458166-B2
Publication Date
2022-10-04
Expiration Date
Abstract
The invention concerns pharmaceutical formulations comprising solvent/detergent (S/D)-treated plasma and a glycosaminoglycan such as hyaluronic acid, and their use for treating diseases, particularly musculoskeletal diseases.
Core Innovation
The invention relates to pharmaceutical formulations comprising solvent/detergent treated plasma (S/D plasma) and hyaluronic acid or a derivative thereof, with the hyaluronic acid or derivative in a concentration ranging from about 1 mg/ml to about 20 mg/ml. The formulations are intended for local treatment of musculoskeletal, bone, and joint diseases, including tendon and ligament diseases, using combinations that include S/D plasma together with the glycosaminoglycan hyaluronic acid or derivative.
A central aspect of the disclosed approach is gelification in situ upon contact with body fluids such as serum, synovial fluid, or whole blood. This gelification forms a viscous or gel matrix that enables localized delivery and/or sustained or slow release of S/D plasma components, including endogenous growth factors, together with hyaluronic acid. The formulation is also described as potentially protecting components from degradation during local use.
The combination is disclosed to be usable with additional components, including serum or whole blood, and with optional active agents. The disclosure further includes cell compositions, such as mesenchymal stem cells (MSC) and osteo- or chondro-lineage cells, and active agents including anti-inflammatory alpha-2 adrenergic receptor agonists such as clonidine and derivatives, and osteogenic or growth factors such as IL-8, FGF-2, TGFβ-1, PDGF, BMPs, PTH, PTHrp, and SCF.
Claims Coverage
The partial content identifies 1 independent claim. The independent claim covers a pharmaceutical formulation defined by the combination of S/D plasma and hyaluronic acid (or derivative) at a specified concentration range, with further claim coverage for administration contexts, osteoarthritis treatment, production by combining the components, and optional inclusion of defined cell compositions and human serum.
S/D plasma combined with hyaluronic acid derivative at specified concentration
A pharmaceutical formulation comprising solvent/detergent treated plasma (S/D plasma) and hyaluronic acid or a derivative thereof, wherein the hyaluronic acid or derivative thereof is in a concentration ranging from about 1 mg/ml to about 20 mg/ml.
Specified peri-/intra tissue administration routes
The formulation is administered via one of several specified routes, including intra-osseous, peri-osseous, intra-articular, peri-articular, intra-tendon, peri-tendon, intra-ligament, or peri-ligament administration.
Osteoarthritis treatment via intra-articular administration
A method for treating osteoarthritis by administering to a subject a therapeutically or prophylactically effective amount of the pharmaceutical formulation via intra-articular administration.
Formulation produced by combining S/D plasma with hyaluronic acid
The pharmaceutical formulation is produced by combining the S/D plasma with hyaluronic acid or a derivative thereof.
Formulation including MSC and specified bone/cartilage cell types
The pharmaceutical formulation includes pharmaceutically active ingredients selected from a group consisting of a cell composition, a pharmaceutically active compound, a protein, a peptide, and a small organic molecule, where the cell composition contains mesenchymal stem cells (MSC) and specified bone and cartilage-related cell types.
Formulation including human serum
The pharmaceutical formulation is further defined as including human serum.
Across the identified independent and dependent coverage, the inventive concept centers on combining S/D plasma with hyaluronic acid (or derivative) within a defined concentration range, with further coverage for particular peri-/intra administration routes, osteoarthritis via intra-articular use, production by combining S/D plasma with hyaluronic acid, and optional inclusion of defined cell compositions and/or human serum.
Stated Advantages
Local treatment via gelification in situ upon contact with body fluids, forming viscous or gel matrices for localized delivery and/or sustained or slow release.
Potential protection of S/D plasma components from degradation.
Documented Applications
Local treatment of musculoskeletal, bone, and joint diseases, including tendon and ligament diseases.
Treatment of osteoarthritis using intra-articular administration of the formulation.
Use as sustained or slow release excipient and as a cell culture medium supplement.
Bone repair in a calvaria osteotomy context using formulations containing S/D plasma, IL-8, and calcium chloride.
Interested in licensing this patent?