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Publication Number
US-9526770-B2
Publication Date
2016-12-27
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 method of inhibiting unwanted bone resorption in an individual in need thereof. The method comprises contacting a bone or joint characterized by unwanted bone resorption with a therapeutically-effective amount of a fetal support tissue comprising cells, substantially all of which have been killed, and HC-HA, thereby inhibiting unwanted bone resorption.
The fetal support tissue includes HC-HA and is derived from placental amniotic membrane, umbilical cord amniotic membrane, placenta, umbilical cord, chorion, amnion-chorion, or combinations thereof. The document also describes cryopreserving, lyophilizing, terminally sterilizing, or combinations of these processing steps, and indicates pharmaceutical compositions and delivery formats intended to contact the bone or joint characterized by unwanted bone resorption.
Contacting can be implemented by injection into a joint or by use with a medical device selected from a patch, an implant, an orthopaedic prosthesis, or a bone stent. The disclosed use encompasses unwanted bone resorption associated with arthritis, osteoporosis, alveolar bone degradation, Paget’s disease, and bone tumors.
Claims Coverage
The claim coverage presents one central inventive concept: inhibiting unwanted bone resorption by contacting a bone or joint with a therapeutically-effective fetal support tissue containing substantially all killed cells and HC-HA. Six inventive features are recited across the claims, covering tissue source, processing, delivery, device format, and associated conditions.
Killed-cell fetal support tissue with HC-HA to inhibit bone resorption
A method of inhibiting unwanted bone resorption in an individual in need thereof by contacting a bone or joint characterized by unwanted bone resorption with a therapeutically-effective amount of a fetal support tissue comprising cells, substantially all of which have been killed, and HC-HA, thereby inhibiting unwanted bone resorption.
Fetal support tissue selected from specified fetal membrane and cord/placental types
The method further uses fetal support tissue selected from placental amniotic membrane (PAM), umbilical cord amniotic membrane (UCAM), placenta, umbilical cord, chorion, amnion-chorion, or combinations thereof.
Processing options for the fetal support tissue
The method further comprises cryopreserving, lyophilizing, terminally sterilizing, or using a combination of these steps.
Joint contacting by injection
The method further comprises injecting fetal support tissue into a joint to contact the joint with unwanted bone resorption.
Device-based delivery using patch, implant, orthopaedic prosthesis, or bone stent
The method is practiced using a medical device selected from a patch, an implant, an orthopaedic prosthesis, or a bone stent.
Application to unwanted bone resorption associated with specified conditions
The method is applied to unwanted bone resorption associated with arthritis, osteoporosis, a bone tumor, Paget’s disease, alveolar bone degradation, or combinations thereof.
The claim set centers on inhibiting unwanted bone resorption by contacting a bone or joint with a therapeutically-effective amount of fetal support tissue having substantially all killed cells and HC-HA. The dependent claims narrow the tissue source, specify processing options, define joint-contacting by injection, specify device-based delivery formats, and identify associated conditions.
Stated Advantages
Inhibits unwanted bone resorption.
Inhibition of osteoclast differentiation and bone resorption associated with the HC-HA complex.
Promotion of osteoblast mineralization.
Documented Applications
Inhibiting unwanted bone resorption associated with arthritis, including osteoarthritis, rheumatoid arthritis, and psoriatic arthritis.
Inhibiting unwanted bone resorption associated with osteoporosis.
Inhibiting unwanted bone resorption associated with alveolar bone degradation.
Inhibiting unwanted bone resorption associated with Paget’s disease.
Inhibiting unwanted bone resorption associated with bone tumors.
Contacting a bone or joint characterized by unwanted bone resorption using a fetal support tissue containing HC-HA and substantially killed cells, including in medical-device delivery formats such as a patch, implant, orthopaedic prosthesis, or bone stent.
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