Decellularized human amniotic membrane for cell delivery, cell culture and inflammation prevention

Patent metadata

Field	Value
Publication number	US-11028362-B2
Application number	US-201615567058-A
Country	US
Kind code	B2
Filing date	Apr 15, 2016
Priority date	Apr 17, 2015
Publication date	Jun 8, 2021
Grant date	Jun 8, 2021

Abstract

Provided herein is an isolated decelluarized amniotic membrane (DCM) and methods for using same therapeutically in vivo and in vitro. In one aspect, the isolated DCM is further processed, freezing, freeze drying, lyophilization micronized into powder or treatment with pepsin to create a hydrogel.

First claim

What is claimed is:

1. A hydrogel composition comprising:
a powdered and freeze dried decellularized amniotic membrane (DCM), the amniotic membrane being decellularized using a method comprising:
adding to the amniotic membrane about a 3% detergent solution comprising t-octylphenoxypolyethoxyethanol solution to lyse the cells,
rinsing with de-ionized water to remove the detergent solution,
adding about a 4% sodium deoxycholic acid solution to further decellularize the membrane,
rinsing with de-ionized water to remove the acid solution,
adding a solution of about 0.1% peracetic acid/4% ethanol solution to remove residual nucleic acids,
rinsing with a composition comprising phosphate buffered saline and subsequently de-ionized water, and
removing excess water;

stem cells;
a non-cytotoxic cross-linking agent; and
a carrier comprising buffered saline.

2. The hydrogel composition of claim 1 , wherein the DCM is processed by lyophilization and micronized into powder.

3. The hydrogel composition of claim 1 , wherein the DCM is derived from placenta isolated from a human, an ovine, a porcine, a bovine, an equine, a feline, a canine or a murine.

4. The hydrogel composition of claim 1 , wherein the carrier is a pharmaceutically acceptable carrier comprising buffered saline.

5. The hydrogel composition of claim 4 , wherein the pharmaceutically acceptable carrier further comprises deionized water or a collagen-based product.

6. The hydrogel composition of claim 1 , wherein the stem cells comprise mesenchymal stem cells, bone marrow stem cells, or placental derived mesenchymal stem cells (PMSCs).

7. The hydrogel composition of claim 1 , further comprising pepsin.

8. The hydrogel composition of claim 1 , wherein the hydrogel composition is a topical gel.

9. The hydrogel composition of claim 1 , further comprising one or more antibiotics, anti-inflammatory agents or growth factors.

10. A kit comprising the hydrogel composition of claim 1 .

11. The kit of claim 10 , further comprising instructions for use.

12. The kit of claim 10 , further comprising instructions for administration by one or more of topical, intraperitoneal, implantation, local, or systemic administration route.

13. A method to culture a cell, comprising mixing an exogenous cell with the hydrogel composition of claim 1 , and culturing the exogenous cell under conditions that favor growth and expansion of the exogenous cell.

14. The method of claim 13 , wherein the mixing is in vitro or in vivo.

15. The method of claim 13 , wherein the exogenous cell is selected from the group consisting of a stem cell and a mesenchymal stem cell.

16. A method to treat a wound, comprising administering to a subject in need thereof, an effective amount of the hydrogel composition of claim 1 , thereby treating the wound.

17. A method for regulating, treating or preventing inflammation in a subject in need thereof, comprising administering to the subject in need thereof, an effective amount of the hydrogel composition of claim 1 , thereby regulating, treating or preventing inflammation.

18. A method for treating or preventing adhesion or scar formation in a subject in need thereof, comprising administering to the subject in need thereof, an effective amount of the hydrogel composition of claim 1 , thereby treating or preventing adhesion or scar formation.

19. A method to treat spinal cord injury or Spina bifida , comprising administering to a subject in need thereof an effective amount of the hydrogel composition of claim 1 , thereby treating spinal cord injury or Spina bifida.

20. A method to promote vascularization in a subject in need thereof, comprising administering to the subject in need thereof, an effective amount of the hydrogel composition of claim 1 , thereby promoting vascularization in the subject.

21. The method of any one of claims 16 to 18 , wherein administration comprises one or more of topical, intraperitoneal, implantation, local, or systemic.

22. The method of claim 21 , wherein the stem cells are autologous or allogeneic to the subject being treated.

23. The method of any one of claims 16 to 20 , wherein the subject is a human, a bovine, an equine, a feline, a canine or a murine.

24. The method of any one of claims 16 to 20 , wherein the composition further comprises one or more antibiotics, anti-inflammatory agents or growth factors.

25. A method to promote neural tissue repair or regeneration, comprising administering to a subject in need thereof an effective amount of the hydrogel composition of claim 1 , thereby promoting neural tissue repair or regeneration.

Assignees

• Univ California

Inventors

• Ryzhuk Volodymyr
• Wang Aijun
• Farmer Diana
• Keller Benjamin

Classifications

• C12N5/0605 Primary

  Cells from extra-embryonic tissues, e.g. placenta, amnion, yolk sac, Wharton's jelly · CPC title

• A61L2430/38

  for reconstruction of the spine, vertebrae or intervertebral discs · CPC title

• A61L27/52

  Hydrogels or hydrocolloids · CPC title

• A61K35/50

  Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells · CPC title

• A61P29/00

  Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] · CPC title