IP Library › Granted Patent US 12,247,225
Granted Patent B2
US 12,247,225 · App. 17/183,927 · Granted Mar 11, 2025

Placental tissue compositions and methods

Inventors: Ji Zhang (North Potomac, MD); Daniel Deegan (Silver Spring, MD); Darryl Roberts (Doylestown, PA)
Assignee: ELUTIA INC.
C12N5/0682C12M3/04C12N2533/92
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Quick Facts
Patent No.
US 12,247,225
App. No.
17/183,927
Granted
Mar 11, 2025
Kind
B2
Abstract

Disclosed herein are methods and compositions of decellularized preterm placental tissue. Compositions comprise decellularized regenerative tissue derived from animal placentas that are harvested preterm, i.e., before the completion of the normal duration of gestation. Preterm placental tissue may contain a high level of growth factors and other beneficial components that aid in tissue regeneration and healing.

Claims (15)

1. A composition comprising decellularized preterm placental tissue, wherein the preterm placental tissue is obtained from an animal in gestation having at least about 1 week to about 20 weeks remaining in a normal gestation period of the animal, wherein at least about 80% of a normal gestation period is complete, and wherein the animal is a mammal selected from the group consisting of bovine, equine, ovine, or porcine.

2. The composition of claim 1 , wherein the decellularized preterm placental tissue comprises one or more of an amnion layer, a chorion layer, and an allantois layer.

3. The composition of claim 1 , wherein the decellularized preterm placental tissue is acellular.

4. The composition of claim 1 , further comprising one or more cells.

5. The composition of claim 4 , wherein the cells are selected from the group consisting of embryonic stem cells, mesenchymal stem cells, progenitor cells, hematopoietic stem cells, other tissue specific stem cells, induced pluripotent stem cells, endothelial cells, smooth muscle cells, cardiomyocyte, fibroblasts, beta cells, white blood cells, macrophage, neurons, Schwann cells, chondrocytes, satellite cells, and combinations thereof.

6. The composition of claim 5 , wherein the cells are human cells.

7. The composition of claim 1 , wherein the decellularized preterm placental tissue comprises one or more growth factors in an amount at least about at least about 120% of the amount of growth factors present in decellularized placental tissue obtained from a full-term placenta of the same animal.

8. The composition of claim 1 , wherein the decellularized preterm placental tissue comprises one or more extracellular matrix components in an amount that is at least about 120% of the amount of extracellular matrix components present in decellularized placental tissue obtained from a full-term placenta of the same animal.

9. The composition of claim 1 , wherein the composition further comprises one or more of an active agent selected from the group consisting of an antibiotic, antifungal agent, anti-viral agent, anti-pain agent, anesthetic, analgesic, steroidal anti-inflammatory, non-steroidal anti-inflammatory, anti-neoplastic, anti-spasmodic, hormone, enzyme, enzyme inhibitor, anticoagulant, antithrombic agent, polypeptide, oligonucleotide, polynucleotide, nucleoprotein, compound modulating cell migration, compound modulating proliferation and growth of tissue, and vasodilating agent.

10. A scaffold comprising decellularized preterm placental tissue incorporated into an encasement structure, wherein the preterm placental tissue is obtained from an animal in gestation having at least about 1 week to about 20 weeks remaining in a normal gestation period of the animal, wherein at least about 80% of a normal gestation period is complete, wherein the animal is a mammal selected from the group consisting of bovine, equine, ovine, or porcine, and wherein the scaffold has a three-dimensional shape that is stable under mechanical stress.

11. The scaffold of claim 10 , wherein the decellularized preterm placental tissue comprises one or more of an amnion layer, a chorion layer, and an allantois layer.

12. The scaffold of claim 10 , wherein the decellularized preterm placental tissue is acellular.

13. The scaffold of claim 10 , further comprising one or more cells.

14. The scaffold of claim 13 , wherein the cells are selected from the group consisting of embryonic stem cells, mesenchymal stem cells, progenitor cells, hematopoietic stem cells, other tissue specific stem cells, induced pluripotent stem cells, endothelial cells, smooth muscle cells, cardiomyocyte, fibroblasts, beta cells, and combinations thereof.

15. The scaffold of claim 14 , wherein the cells are human cells.

Assignments (6)
SECURITY INTEREST Recorded Aug 11, 2026
From: ELUTIA INC.
To: AVENUE VENTURE OPPORTUNITIES FUND II, L.P.
Reel/Frame 075616/0070 →
CHANGE OF NAME Recorded Dec 11, 2023
From: AZIYO BIOLOGICS, INC.
To: ELUTIA INC.
Reel/Frame 065852/0357 →
SECURITY INTEREST Recorded Aug 12, 2022
From: AZIYO BIOLOGICS, INC.; AZIYO MED, LLC
To: SWK FUNDING LLC
Reel/Frame 060792/0045 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 28, 2021
From: ZHANG, JI
To: AZIYO BIOLOGICS INC.
Reel/Frame 056072/0790 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 28, 2021
From: DEEGAN, DANIEL
To: AZIYO BIOLOGICS INC.
Reel/Frame 056072/0856 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 28, 2021
From: ROBERTS, DARRYL
To: AZIYO BIOLOGICS INC.
Reel/Frame 056072/0901 →
Continuity (2)
Provisional Application 62983060 · Feb 28, 2020
Related Publication 20210269775A1 · Sep 2, 2021
References Cited (46)
US 4902508A · Badylak et al. · 1990 [cited by applicant]
US 5281422A · Badylak et al. · 1994 [cited by applicant]
US 5554389A · Badylak et al. · 1996 [cited by applicant]
US 8231908B2 · Kinoshita et al. · 2012 [cited by applicant]
US 8372439B2 · Daniel et al. · 2013 [cited by applicant]
US 8735054B1 · Sun et al. · 2014 [cited by applicant]
US 10052351B2 · Koob · 2018 [cited by applicant]
US 20090246773A1 · Caniggia et al. · 2009 [cited by applicant]
US 20100028306A1 · Clarke et al. · 2010 [cited by applicant]
US 20140271728A1 · Koob et al. · 2014 [cited by applicant]
US 20150216912A1 · Koob · 2015 [cited by applicant]
US 20150306150A1 · Zhang et al. · 2015 [cited by applicant]
US 20150320906A1 · Broussard · 2015 [cited by applicant]
US 20190365948A1 · Deegan et al. · 2019 [cited by applicant]
CN 105688287A · 2016 [cited by applicant]
WO 2017112934A1 · 2017 [cited by applicant]
Fratini et al., Canine placenta recellualrized using yolk sac cells with vascular endothelial growth factor. BioResearch Open Access, vol. 7, No. 1 (Jul. 1, 2018) pp. 101-106 (Year: 2018). [cited by examiner]
Burke, A., “How long are dogs pregnant” American Kennel Club (May 3, 2021, [online], [retrieved on May 12, 2023]. Retrieved from the Internet: <URL: https://www.akc.org/expert-advice/dog-breeding/how-long-are-dogs-pregn… [cited by examiner]
Barreto et al., Decellularlized bovine cotyledons may serve as biological scaffolds with preserved vascular arrangement. Tissue Engineering and Regenerative Medicine, vol. 12, No. 4 (Apr. 2018) e1880-e1888 (Year: 2018). [cited by examiner]
Pregnant cows, timing of pregnancy, open cows, pregnancy rate. University of Nebraska, Lincoln [online], 2023 [retrieved on May 12, 2023]. Retrieved from the Internet: <URL: https://beef.unl.edu/faq/pregnant-cows> (Year… [cited by examiner]
Devi et al., Expression and functional role of fibroblast growth factors (FGF) in placenta during different stages of pregnancy in water buffalo ( [cited by examiner]
Flynn et al., Decellularized placental matrices for adipose tissue engineering. Journal of Biomedical Materials Research, vol. 79A, No. 2 (Nov. 2006) pp. 359-369 (Year: 2006). [cited by examiner]
Barreto et al., Mouse placental scaffolds: a three-dimensional environment model for recellularization. Journal of Tissue Engineering. vol. 10 (2019) doi:10.1177/2041731419867962 (Year: 2019). [cited by examiner]
Queensberry et al., Breeding and Reproduction of Mice. Merck Manual (2020) (Year: 2020). [cited by examiner]
Shakouri-Motlagh et al., The application of decellularized human term fetal membranes in tissue engineering and regenerative medicine (TERM). Placenta, vol. 59 (2017) pp. 124-130 (Year: 2017). [cited by examiner]
Badylak et al., “Progress in Tissue Engineering and Regenerative Medicine,” Proc Natl Acad Sci USA, 107 (8):3285-3286 (2010). [cited by applicant]
International Preliminary Report on Patentability for International PCT Application No. PCT/US2018/014742 dated Feb. 1, 2019. [cited by applicant]
International Search Report and Written Opinion for International PCT Application No. PCT/US2018/014742 dated Mar. 26, 2018. [cited by applicant]
Quinby, “Plastic and Reconstructive Surgery,” 1982, 70, 6, 711-716. [cited by applicant]
Sheridan et al., “Tissue Engineering: Part C,” 2013, 19, 12, 981-990. [cited by applicant]
Barreto et al., “Decellularized Bovine Cotyledons May Serve as Biological Scaffolds with Preserved Vascular Arrangement,” J Tissue Eng Regen Med, 2018, 12, e1880-e1888. [cited by applicant]
Devi et al., “Expression and Functional Role of Fibroblast Growth Factors (FGF) in Placenta During Different Stages of Pregnancy in Water Buffalo ( [cited by applicant]
Faulk et al., “Human Amnion as an Adjunct in Wound Healing,” The Lancet, 1980, 1156-1158. [cited by applicant]
Favaron et al., “Establishment of 3-Dimensional Scaffolds from Hemochorial Placentas,” Placenta, 2019, 81, 32-41. [cited by applicant]
Fratini et al., “Canine Placenta Recellularized Using Yolk Sac Cells with Vascular Endothelial Growth Factor,” BioResearch Open Access, 2018, 7:1, 101-106. [cited by applicant]
InnovaMatrix 510(k) FDA Pre-market Notification ID K193552 dated Dec. 20, 2019 filed by Triad Life Sciences, Inc. [cited by applicant]
Matias et al., “Optimization of Canine Placenta Decellularization: An Alternative Source of Biological Scaffolds for Regenerative Medicine,” Cells Tissues Organs, 2018, 205, 217-225. [cited by applicant]
Oliveira et al., “Composition and Significance of Glycosaminoglycans in the Uterus and Placenta of Mammals,” Braz Arch Biol Technol, 2015, 58:4, 512-520. [cited by applicant]
Third Party Observation re: International Application No. PCT/US2021/019389 submitted to the International Bureau on Jun. 20, 2022. [cited by applicant]
Elshenawy et al., “The Metabolic Signature of the Placenta in Spontaneous Preterm Birth,” International Journal of Molecular Sciences (Feb. 4, 2020) vol. 21, No. 3, Article 1043, pp. 1-21. [cited by applicant]
International Search Report and Written Opinion for International PCT Patent Application No. PCT/US2021/019389 dated May 24, 2021. [cited by applicant]
Schneider et al., “Decellularized human placenta chorion matrix as a favorable source of small-diameter vascular grafts”, Acta Biomaterialia, 29, pp. 125-134, Jan. 29, 2016. [cited by applicant]
Benson-Martin et al., “The Young's modulus of fetal preterm and term amniotic membranes,” European Journal of Obstetrics & Gynecology and Reproductive Biology, Elservier Ireland Ltd., IE, vol. 128, No. 1-2, Sep. 1, 2006… [cited by applicant]
Extended European Search Report for EP 21760549.2 dated Mar. 15, 2024 (9 pages). [cited by applicant]
Leonel et al., “Decellularization of placentas: establishing a protocol,” Brazilian Journal of Medical and Biological Research, Dec. 2010, vol. 51, No. 1, Nov. 17, 2017, p. e6382, XP009514687. [cited by applicant]
Portmann-Lanz et al., “Manufacture of a Cell-free Amnion Matrix Scaffold that Supports Amnion Cell Outgrowth In Vitro,” Placenta, WB Saunders GB vol. 28, No. 1, Nov. 17, 2006 pp. 6-13, XP005739883. [cited by applicant]