IP Library › Granted Patent US 12,447,232
Granted Patent B2
US 12,447,232 · App. 18/220,928 · Granted Oct 21, 2025

Translucent, dehydrated placental tissue and methods of producing and using the same

Inventors: John Daniel (Milton, GA); Sarah Griffiths (Sandy Springs, GA); Annelise Mowry Roy (Cumming, GA)
Assignee: StimLabs LLC
A61L27/3604A61K35/50A61L27/3691A61L27/50A61L27/54A61P17/02A61L2430/40
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Quick Facts
Patent No.
US 12,447,232
App. No.
18/220,928
Granted
Oct 21, 2025
Kind
B2
Abstract

Compositions comprising translucent, dehydrated placental tissue and methods of preparing and using those tissues are provided. Repeated dehydration techniques may produce translucent, dehydrated placental tissues, including translucent, dehydrated placental membrane and umbilical cord, with improved visualization and/or handling characteristics. The present invention also includes methods of healing a wound of the skin, eye, nerve, tendon, muscle, dental region, or dura, including burns, comprising applying the translucent, dehydrated placental tissues of the invention to the wound.

Claims (29)

1. A method of preparing dehydrated umbilical cord or a composition thereof comprising:

a. obtaining an umbilical cord dissected away from the placental disc;

b. dissecting the umbilical cord to completely, substantially, or partially remove the vessel walls of the umbilical cord vein and arteries;

c. performing at least two washing steps to remove blood remnants, wherein at least one of the washing steps comprises washing the umbilical cord in a sodium chloride solution containing a w/v concentration of 18% to 30%, and at least one of the washing steps comprises washing the umbilical cord in purified water;

d. perforating the umbilical cord; and

e. dehydrating the umbilical cord in a dehydration environment;

wherein the umbilical cord and/or the dehydrated umbilical cord comprises Wharton's Jelly.

2. The method of claim 1 , further comprising hydrating the dehydrated umbilical cord in a hydration environment and dehydrating the umbilical cord in a second dehydration environment, wherein the second dehydration step comprises oven drying.

3. The method of claim 1 , wherein the dehydrating in step (e) comprises lyophilizing.

4. The method of claim 3 , wherein the method comprises a second dehydration step, a third dehydration step, a fourth dehydration step, a fifth dehydration step, a sixth dehydration step, a seventh dehydration step, and/or an eighth dehydration step before the final dehydration step; wherein the placental tissue is hydrated between any two dehydration steps; and wherein the second, third, fourth, fifth, sixth, seventh, and/or eighth dehydration steps comprise oven-drying.

5. The method of claim 1 , wherein the dehydrating in step (e) reduces the moisture content of the umbilical cord by 99.9%, 99.8%, 99.7%, 99.6%, 99.5%, 99.4%, 99.3%, 99.2%, 99.1%, 99%, 98.5%, 98%, 97%, 96%, 95%, 94%, 93%, 92%, 93%, 92%, 91%, 90%, 85%, or 80%.

6. The method of claim 1 , further comprising partially or substantially removing the epithelial layer and/or removing epithelial cells from the umbilical cord.

7. The method of claim 1 , wherein perforating occurs in between at least two washing steps.

8. The method of claim 1 , comprising pretreating the umbilical cord before performing any washing steps to remove material from the surface or loosen material from the interior of the umbilical cord.

9. The method of claim 1 , wherein the umbilical cord is washed in at least three washing steps, at least four washing steps, at least five washing steps, at least six washing steps, at least seven washing steps, at least eight washing steps, at least nine washing steps, or at least ten washing steps.

10. The method of claim 9 , wherein the at least one suitable washing medium for one of the additional washing steps is selected from water, a sodium chloride solution, a sodium hypochlorite solution, a hydrogen peroxide solution, Lactated Ringer's solution, Ringer's solution, phosphate-buffered saline (PBS), tris-buffered saline (TBS), Hank's balanced salt solution (HBSS), Dulbecco's phosphate-buffered saline (DPBS), Earle's balanced salt solution (EBSS), standard saline citrate (SSC), HEPES-buffered saline (HBS), Gey's balanced salt solution (GBSS), and a cell culture medium.

11. The method of claim 10 , wherein the sodium chloride solution contains a w/v concentration of NaCl of 24% to 28%.

12. The method of claim 11 , comprising a first washing step comprising washing the umbilical cord in a sodium chloride solution, a further washing step comprising washing the umbilical cord in purified water, a further washing step comprising washing the umbilical cord in a sodium chloride solution, and a further washing step comprising washing the umbilical cord in purified water, wherein the sodium chloride solution contains a w/v concentration of NaCl of about 26%.

13. The method of claim 12 , further comprising cutting the dehydrated umbilical cord to a diameter, length, or width of 3 mm, less than 3 mm, 2 mm, less than 2 mm, 1 mm, or less than 1 mm.

14. The method of claim 12 , further comprising cutting the dehydrated umbilical cord to a diameter, length, or width of 1 cm, 1.5 cm, 2 cm, 3 cm, 4 cm, 5 cm, or 6 cm.

15. The method of claim 12 , further comprising sterilizing the dehydrated umbilical cord.

16. The method of claim 1 , wherein the umbilical cord and/or the dehydrated umbilical cord comprises proteoglycans and/or glycosaminoglycans.

17. The method of claim 1 , wherein the umbilical cord is from a human donor.

18. A composition comprising dehydrated umbilical cord produced according to the method of claim 1 , wherein the dehydrated umbilical cord has a hemoglobin content of less than 13 ng/mg, less than 10 ng/mg, less than 5 ng/mg, less than 1 ng/mg, or less than 0.5 ng/mg of dry mass of the umbilical cord; or has a hemoglobin content that is reduced in an amount greater than about 50%, 60%, 70%, 80%, 90%, or 95%.

19. A method of treating or covering a wound of a subject comprising applying the composition of claim 18 to the wound of the subject.

20. A composition comprising dehydrated umbilical cord produced according to the method of claim 2 , wherein the dehydrated umbilical cord has a hemoglobin content of less than 13 ng/mg, less than 10 ng/mg, less than 5 ng/mg, less than 1 ng/mg, or less than 0.5 ng/mg of dry mass of the umbilical cord; or has a hemoglobin content that is reduced in an amount greater than about 50%, 60%, 70%, 80%, 90%, or 95%.

21. A method of treating or covering a wound of a subject comprising applying the composition of claim 20 to the wound of the subject.

22. A composition comprising dehydrated umbilical cord, wherein the dehydrated umbilical cord comprises Wharton's Jelly and is perforated, and wherein the dehydrated umbilical cord has a hemoglobin content of less than 13 ng/mg, less than 10 ng/mg, less than 5 ng/mg, less than 1 ng/mg, or less than 0.5 ng/mg of dry mass of the umbilical cord.

23. A method of treating or covering a wound of a subject comprising applying the composition of claim 22 to the wound of the subject.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 13, 2023
From: DANIEL, JOHN; GRIFFITHS, SARAH; ROY, ANNELISE MOWRY
To: STIMLABS LLC
Reel/Frame 064893/0939 →
Continuity (4)
Continuation 17486642 · Sep 27, 2021
Division 16225733 · Dec 19, 2018
Provisional Application 62609771 · Dec 22, 2017
Related Publication 20240024536A1 · Jan 25, 2024
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