LAMINATED TISSUE GRAFTS COMPOSED OF WHARTON'S JELLY AND METHODS OF MAKING AND USING THE SAME

• US 20190307921A1
• Filed: 05/23/2019
• Published: 10/10/2019
• Est. Priority Date: 02/14/2011
• Status: Active Grant

• Current Assignee: Mimedx Group Incorporated
• Original Assignee: Mimedx Group Incorporated
• Inventors: Morse, Brenda S., Sith, Somaly, Spencer, Randall, Daniel, John, Tofe, Robert
• Granted Patent: US 11,602,549 B2
• Time in Patent Office: Days
• CPC Class Codes: A61K 35/50 Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
• CPC Class Codes: A61L 2430/12 for dental implants or prostheses
• CPC Class Codes: A61L 2430/40 Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/365 Bones
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 27/16 Otologicals

Abstract

Described herein are tissue grafts derived from the placenta with improved physical and biological properties. In one aspect, the tissue graft includes a first membrane comprising Wharton'"'"'s jelly laminated with amnion, chorion, or a combination thereof. The presence of Wharton'"'"'s jelly in the grafts enhances the performance of allograft amniotic-derived, caderivic allograft, xenograft, or alloplast soft tissue substitutes.

Claims

1. A tissue graft comprising a first membrane comprising Wharton'"'"'s jelly laminated with amnion, chorion, or a combination thereof.

2. The graft of claim 1, wherein the graft comprises (1) a first membrane comprising Wharton'"'"'s jelly;

(2) chorion, wherein the chorion comprises a chorion stromal layer, wherein the chorion stromal layer is adjacent to the Wharton'"'"'s jelly; and

(3) amnion, wherein the amnion comprises an exposed basement membrane and an amnion stromal layer, wherein the amnion stromal layer is adjacent to the chorion.

3. The graft of claim 1, wherein the graft comprises (1) a first membrane comprising Wharton'"'"'s jelly;

and (2) amnion, wherein the amnion comprises an exposed basement membrane and an amnion stromal layer, wherein the amnion stromal layer is adjacent to the Wharton'"'"'s jelly.

4. The graft of claim 2, wherein the intermediate layer of the amnion has been substantially removed.

5. The graft of claim 3, wherein the intermediate layer of the amnion has been substantially removed.

6. The graft of claim 1, wherein the graft is embossed with a picture, letter or symbol to designate sidedness.

7. The graft of claim 1, wherein the graft is substantially dry prior to use.

8. The graft of claim 1, wherein the graft is hydrated prior to use.

9. The graft of claim 1, wherein the graft is hydrated with an aqueous solution comprising naturally occurring growth factors sourced from platelet concentrates, either using autologous blood collection and separation products, or xenograft sources such as fetal swine teeth and blood concentrates, purified natural bioactive agents, recombinant biological modifiers such as recombinant platelet derived growth factor and recombinant fibroblast growth factor, or any combination thereof.

10. The graft of claim 1, wherein the graft is between 0.1 to 2 mm in thickness.

11. The graft of claim 1, wherein the graft is about 1 mm in thickness.

12. The graft of claim 1, wherein the graft comprises laminin and laminin-5.

13. The graft of claim 1, wherein the graft is from about 1 cm×

1 cm to about 2 cm×

4 cm in size.

14. The graft of claim 1, wherein the graft is soaked in platelet concentrates prior to use sourced from expired banked blood.

15. The graft of claim 1, wherein the graft is soaked with a bioactive agent comprising naturally occurring growth factors sourced from platelet concentrates, either using autologous blood collection and separation products;

allograft placentas;

bone marrow aspirate;

a solution of purified natural bioactive agents, recombinant bioactive agents, or any combination thereof.

16. The graft of claim 1, wherein the graft comprises (1) a first membrane comprising Wharton'"'"'s jelly;

(2) a biologically compatible material adjacent to the Wharton'"'"'s jelly; and

(3) amnion, wherein the amnion comprises an exposed basement membrane and an amnion stromal layer, wherein the amnion stromal layer is adjacent to the biologically compatible material, wherein the biologically compatible material, comprises multiple layers of amnion, chorion, allograft pericardium, allograft acellular dermis, amniotic membrane (i.e., both amnion and chorion), umbilical vein, purified xenograft Type-1 collagen, biocellulose polymers or copolymers, biocompatible synthetic polymer or copolymer films, purified small intestinal submucosa, bladder acellular matrix, cadaveric fascia, or any combination thereof.

17. The graft of claim 1, wherein the graft further comprises one or more bone grafts.

18. A method for facilitating vascularization of a wounds and promote wound healing, the method comprising contacting the wound site with the graft of claim 1.

19. A method for facilitating cell migration of gingival epithelia cells and promote attachment of gingival epithelia direct attachment cells, the method comprising contacting the gingival epithelia cells with the graft of claim 1.

20. A method for promoting would healing associated with a dental surgical procedure, wherein the dental surgical procedure comprises contacting the wound with the graft of claim 1.

21. The method of claim 20, wherein the wound is at the oral mucosa, or alveolar bone or dental tissue (e.g., tooth, root or bone).

22. The method of claim 20, wherein the graft does not require sutures or staples, and wherein at least one side of the graft is adherent.

23. The method of claim 20, wherein the dental surgical procedure is for treating or preventing gingival recession;

for vertical or horizontal gingival augmentation;

for treating or tissue augmentation around dental implants;

periodontal plastic surgery;

for the elimination of frenum pull;

for the regeneration of papilla tissue;

vestibuloplasty;

guided tissue regeneration;

guided bone regeneration;

a grafting an extraction socket;

for the treatment of an intrabony osseous defect;

for primary or secondary ridge augmentation;

for fenestration and dehiscence osseous defect;

for covering the lateral window of the sinus;

for repairing a tear in the Schendiarn membrane;

for mouth treating sores and/oral lesions; and

for regenerating tissue lost through disease or traumatic injury.

24. A method for promoting would healing associated with a discontinuity in a structure, the method comprising covering the discontinuity with the graft of claim 1.

25. The method of claim 24, wherein the discontinuity is an exposed root;

an incision;

an osseous defect filled with bone graft, either autogenous bone or bone graft substitute;

an extraction socket;

an intrabony defect;

an osseous defect in primary or secondary ridge augmentation;

or a fenestration and dehiscence osseous defect

26. The method of claim 24, wherein the discontinuity is an incision made during a dental procedure adjacent to the defect and/or at the gingival margin, the method comprising lifting the tissue to permit direct access to the surgical area and positioning the graft over the exposed root surface in such a manner the amnion present in the graft faces the tooth surface.

27. The method of claim 24, wherein the discontinuity is an incision made during a dental procedure adjacent to the defect, the method comprising lifting the tissue and sliding or tunneling the graft underneath the tissue and positioned over the exposed root surface in such a manner that the amnion present in the graft faces the tooth surface.

28. The method of claim 24, wherein the discontinuity is an incision made at the gingival margin apical to the defect, the method comprising lifting the gingival tissue and sliding or poaching the graft underneath the tissue and positioned over the exposed root surface in such a manner that the amnion present in the graft faces the tooth surface.

29. A method for preventing or reducing scar formation on or near the spine after a surgical procedure, the method comprising applying to a subject a tissue graft of claim 1 directly to the spinal dura of the subject or a region near the spine.

30. The method of claim 29, wherein the surgical procedure comprises a posterior procedure.

31. The method of claim 30, wherein the posterior procedure is a laminectomy or discectomy.

32. The method of claim 30, wherein the posterior procedure is an Anterior Lumbar Interbody Fusion (ALIF) and Transforaminal Interbody Fusion (TLIF).

33. The method of claim 29, wherein the surgical procedure comprises an anterior procedure.

34. The method of claim 29, wherein the amnion present in the graft comprises an exposed basement layer.

35. A method for treating a dural tear in a subject, the method comprising applying directly to the dural tear a tissue graft of claim 1.

36. The method of claim 35, wherein the amnion present in the graft comprises an exposed basement layer.

37. A method for promoting wound healing associated with an orthopedic application, wherein the method comprises contacting the wound with the graft of claim 1.

38. The method of claim 37, wherein the graft is used in tendon repair, aiding in the repair of periostium, repairing ruptured/damaged bursa, or securing void filling materials during bone repair.

39. A method for promoting wound healing associated with an ENT application, wherein the method comprises contacting the wound with the graft of claim 1.

40. The method of claim 39, wherein the ENT application is tympanoplasty, a wound from an adenoidectomy, a wound from a tonsillectomy, or repair of the Sniderian membrane.

41. A method for promoting wound healing involving a subject'"'"'s extremities, wherein the method comprises contacting the wound with the graft of claim 1.

43. A method for promoting wound healing associated with an ophthalmological application, wherein the method comprises contacting the wound with the graft of claim 1.

44. The method of claim 43, wherein the graft is an on-lay graft for ocular surface repair.

45. A method for promoting wound healing associated with a gynecological application, wherein the method comprises contacting the wound with the graft of claim 1.

46. The method of claim 45, wherein the graft is an anti-adhesion barrier after removal of ovarian cyst or aids in the repair of vaginal wall erosion.

47. A method for promoting wound healing associated with an urological application, wherein the method comprises contacting the wound with the graft of claim 1.

48. The method of claim 47, wherein the graft facilitates closure of the vas deferens during vasectomy reversal or facilitates closure of the vas deferens resulting from trauma.

49. A method for promoting wound healing associated with general surgery, wherein the method comprises contacting the wound with the graft of claim 1.

50. The method of claim 49, wherein the graft facilitates closure of anastomosis, is an anti-adhesion barrier for anastomosis, or is an anti-adhesion barrier for hernia repair.

51. A method for promoting wound healing in the human mucosa in the oral cavity, nose, throat, vagina, and rectum, the method comprising contacting the wound site with the graft of claim 1.

52. A method for promoting the healing of a wound in a subject, the method comprising applying to the wound the graft of claim 1, wherein the wound is in the cranial dura, a wound resulting from a perioplastic procedure, for the elimination of a frenum pull, for the regeneration of lost patella tissue, for the repair of the Schneiderian membrane in the sinus cavity, or the soft tissue around dental implants.

53. A method for preventing or reducing scar formation on or near a wound, the method comprising applying to the wound the graft of claim 1.

54. The method of claim 53, wherein wound is associated with spinal surgery, repair of joints, ligaments, tendons, bone fractures, osteochondral defects, tympanic membrane repair, abdominal surgery, ophthalmic surgery, choric wounds, diabetic ulcers, burns, vascular surgery, rhinoplasty, tonsillectomies, and facial reconstruction.

55. The use of the graft of claim 1 as an adhesion barrier, spinal surgery, repair of joints, ligaments, tendons, bone fractures, osteochondral defects, tympanic membrane repair, abdominal surgery, ophthalmic surgery, choric wounds, diabetic ulcers, burns, vascular surgery, rhinoplasty, tonsillectomies, and facial reconstruction.

42. The method of claim 42, wherein the graft is an anti-adhesion barrier for small bone fixation, an anti-adhesion barrier where metal plating or hardware is used, or promote the repair of ruptured/damaged bursa.