IP Library Granted Patent US 12,397,086
Granted Patent B2
US 12,397,086 · App. 15/588,331 · Granted Aug 26, 2025

Methods of modulating bone remodeling

Inventors: Scheffer Tseng (Pinecrest, FL); Ek Kia Tan (Miami, FL); Hua He (Miami, FL)
Assignee: BIOTISSUE HOLDINGS INC.
A61L27/365A61K9/0019A61K31/728A61K33/06A61K35/50A61K35/51A61K35/54A61K38/57A61L27/20A61L27/26A61L27/34A61L27/3604A61L27/3847A61L27/54A61L2300/236A61L2300/252A61L2300/434A61L2300/45A61L2300/606A61L2430/02
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Quick Facts
Patent No.
US 12,397,086
App. No.
15/588,331
Granted
Aug 26, 2025
Kind
B2
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.

Claims (21)

1. 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, wherein the UCAM or an extract thereof does not comprise placental amniotic membrane; and wherein 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, wherein the bone implant inhibits osteoclast formation.

2. The bone implant of claim 1 , wherein UCAM or the extract thereof comprises at least 25.0 μg/ml of HC-HA/PTX3 complex.

3. The bone implant of claim 1 , wherein the UCAM or the extract thereof is formulated as a sheet, a pulverized powder, or a homogenate.

4. The bone implant of claim 1 , wherein the UCAM or the extract thereof comprises a pharmaceutically acceptable diluent, excipient, or carrier.

5. The bone implant of claim 1 , wherein the UCAM or the extract thereof is formulated as a solution, suspension, paste, ointment, oil, emulsion, microemulsion, cream, lotion, gel, or any combination thereof.

6. The bone implant of claim 1 , wherein the UCAM or the extract thereof is a sheet.

7. The bone implant of claim 1 , wherein the UCAM or the extract thereof is coated onto an outside surface of the bone implant.

8. The bone implant of claim 1 , wherein the UCAM or the extract thereof is configured to elute from the bone implant.

9. The bone implant of claim 6 , wherein the sheet is wrapped around an osteolytic bone or osteolytic joint.

10. The bone implant of claim 1 , wherein the bone implant is formulated for injection at arthritic joints of an individual.

11. The bone implant of claim 1 , wherein the bone implant is further formulated for administration by an implant or by a patch.

12. The bone implant of claim 1 , wherein the UCAM or the extract thereof inhibits undesired osteoclast differentiation.

13. The bone implant of claim 12 , wherein the undesired osteoclast differentiation causes arthritis, osteoporosis, bone tumor, Paget's disease, alveolar bone degradation, or any combination thereof.

14. The bone implant of claim 13 , wherein the arthritis comprises osteoarthritis, rheumatoid arthritis, psoriatic arthritis, or any combination thereof.

15. The bone implant of claim 1 , wherein the UCAM or the extract thereof inhibits osteoclast activity.

16. The bone implant of claim 15 , wherein the osteoclast activity causes arthritis, osteoporosis, bone tumor, Paget's disease, alveolar bone degradation, or any combination thereof.

17. The bone implant of claim 1 , wherein the UCAM or extract thereof is water-soluble.

18. The bone implant of claim 1 , wherein the bone implant is formed or formulated as a bone stent, an osseointegrated implant, a micronized powder, a sheet, or an orthopedic prosthesis.

19. The bone implant of claim 1 , wherein UCAM or the extract thereof comprises at least 0.2 μg/ml of HC-HA/PTX3 complex.

20. The bone implant of claim 1 , wherein UCAM or the extract thereof comprises at least 1.0 μg/ml of HC-HA/PTX3 complex.

21. The bone implant of claim 1 , wherein UCAM or the extract thereof comprises at least 5.0 μg/ml of HC-HA/PTX3 complex.

Assignments (7)
RELEASE OF SECURITY INTEREST Recorded Jun 7, 2024
From: MIDCAP FUNDING IV TRUST
To: BIOTISSUE HOLDINGS INC. (F/K/A TISSUE TECH, INC.); BIOTISSUE OCULAR INC. (F/K/A BIO-TISSUE, INC.); BIOTISSUE SURGICAL INC. (F/K/A AMNIOX MEDICAL, INC.)
Reel/Frame 067666/0200 →
RELEASE OF SECURITY INTEREST Recorded Jun 7, 2024
From: MIDCAP FINANCIAL TRUST
To: BIOTISSUE HOLDINGS INC. (F/K/A TISSUE TECH, INC.); BIOTISSUE OCULAR INC. (F/K/A BIO-TISSUE, INC.); BIOTISSUE SURGICAL INC. (F/K/A AMNIOX MEDICAL, INC.)
Reel/Frame 067666/0165 →
SECURITY INTEREST Recorded Jun 7, 2024
From: BIOTISSUE HOLDINGS INC.; BIOTISSUE OCULAR INC.; BIOTISSUE SURGICAL INC.
To: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 067666/0235 →
CHANGE OF NAME Recorded May 10, 2023
From: TISSUETECH, INC.
To: BIOTISSUE HOLDINGS INC.
Reel/Frame 063600/0798 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT - REVOLVING LOAN Recorded May 18, 2022
From: TISSUETECH, INC.; BIO-TISSUE, INC.; AMNIOX MEDICAL, INC.
To: MIDCAP FUNDING IV TRUST
Reel/Frame 060116/0468 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT - TERM LOAN Recorded May 18, 2022
From: TISSUETECH, INC.; BIO-TISSUE, INC.; AMNIOX MEDICAL, INC.
To: MIDCAP FINANCIAL TRUST
Reel/Frame 060116/0413 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 9, 2017
From: TSENG, SCHEFFER; TAN, EK KIA; HE, HUA
To: TISSUETECH, INC.
Reel/Frame 042294/0446 →
Continuity (4)
Continuation 15348736 · Nov 10, 2016
Continuation 14004992
Provisional Application 61480281 · Apr 28, 2011
Related Publication 20170239389A1 · Aug 24, 2017
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