Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12397086-B2
Publication Date
2025-08-26
Expiration Date
Abstract
Disclosed herein, in certain instances, are methods of inhibiting osteoclast differentiation, bone resorption, bone formation, and bone remodeling in an individual in need thereof, comprising administering to the individual a composition comprising substantially fetal support tissue product including amniotic membrane and umbilical cord or an extract thereof, or a composition comprising substantially isolated HC-HA complex.
Core Innovation
The invention relates to a bone implant comprising a fetal support tissue product comprising umbilical cord amniotic membrane (UCAM) or an extract thereof, where the UCAM or the extract thereof is cryopreserved, lyophilized, terminally sterilized, or a combination thereof. The UCAM or the extract thereof does not comprise placental amniotic membrane, and the implant comprises at least 0.08 μg/ml heavy chain (HC) of inter-alpha-inhibitor (IαI), hyaluronan (HA), and PTX3 (HC-HA/PTX3) complex.
The UCAM or the extract thereof comprises HC-HA/PTX3 complex and the bone implant inhibits osteoclast formation. The disclosed compositions maintain an HC-HA complex with HA and PTX3 as part of an HC-HA/PTX3 complex present at the defined level in the implant.
The invention further relates to therapeutic bone implants and methods for modulating bone remodeling by administering fetal support tissue products. The disclosed uses include treatment of arthritis, osteoporosis, Paget’s disease, alveolar bone degradation, and bone tumors, with administration formats including injection, patches, and implants/orthopaedic prostheses/bone stents.
Claims Coverage
The independent claim covers a bone implant defined by specific fetal support tissue material processing, exclusion of placental amniotic membrane, incorporation of an HC-HA/PTX3 complex at a stated minimum level, and inhibition of osteoclast formation. Four inventive features are identified.
Bone implant with UCAM or extract processed and excluding placental amniotic membrane
A bone implant comprising a fetal support tissue product comprising umbilical cord amniotic membrane (UCAM) or an extract thereof, wherein the UCAM or the extract thereof is cryopreserved, lyophilized, terminally sterilized, or a combination thereof, and wherein the UCAM or the extract thereof does not comprise placental amniotic membrane.
Defined HC-HA/PTX3 complex content
The UCAM or the extract thereof comprises at least 0.08 μg/ml heavy chain (HC) of inter-alpha-inhibitor (IαI), hyaluronan (HA), and PTX3 (HC-HA/PTX3) complex.
Osteoclast formation inhibition
The bone implant inhibits osteoclast formation.
Overall, the claims center on a UCAM-based bone implant or extract that is processed, excludes placental amniotic membrane, contains at least a defined HC-HA/PTX3 complex level, and inhibits osteoclast formation.
Stated Advantages
Inhibits osteoclast formation.
Supports osteoblast mineralization.
Supports balancing bone resorption and bone formation and promoting mineralization/bone formation.
Documented Applications
Arthritis contexts including osteoarthritis, rheumatoid arthritis, psoriatic arthritis, or combinations thereof.
Osteoclast formation inhibition associated with bone-related conditions described in the document, including osteoporosis, Paget's disease, alveolar bone degradation, bone tumor, osteolysis, and osteoarthritis.
Bone implant use in connection with osteoblast mineralization.
Treatment of osteoporosis.
Treatment of Paget’s disease.
Treatment of alveolar bone degradation.
Treatment of bone tumors.
Interested in licensing this patent?