Placental tissue grafts produced by chemical dehydration/freeze-drying and methods for making and using the same

Patent metadata

Field	Value
Publication number	US-9687588-B2
Application number	US-201514932874-A
Country	US
Kind code	B2
Filing date	Nov 4, 2015
Priority date	Dec 2, 2011
Publication date	Jun 27, 2017
Grant date	Jun 27, 2017

Abstract

Described herein are placental tissue grafts produced by chemical dehydration followed by freeze-drying the placental tissue to produce the tissue graft. The tissue grafts retain their biological properties preferably at the same level as the placental tissues before they are processed. The placental tissue grafts have numerous medical applications. Methods for making the tissue graft compositions are also described herein.

First claim

What is claimed:

1. A method for enhancing wound healing in a subject comprising applying to the wound a placental tissue graft produced by the method comprising:
a) laminating at least two placental tissues together;
b) chemically dehydrating the placental tissues; and
c) freeze-drying the placental tissues to produce the tissue graft,
wherein the at least two placental tissues are selected from the group consisting of: (1) at least two layers of chorion, (2) at least two layers of cellularized amnion membrane, and (3) at least one layer of chorion and at least one layer of cellularized amnion membrane.

2. The method of claim 1 , wherein the wound is a chronic wound.

3. The method of claim 1 , wherein the wound is an acute wound.

4. A method for preventing or reducing scar formation on or near the spine of a subject after a surgical procedure, the method comprising applying directly to the spinal dura of the subject or a region near the spine a placental tissue graft produced by the method comprising:
a) laminating at least two placental tissues together;
b) chemically dehydrating the placental tissues; and
c) freeze-drying the placental tissues to produce the tissue graft,
wherein the at least two placental tissues are selected from the group consisting of: (1) at least two layers of chorion, (2) at least two layers of cellularized amnion membrane, and (3) at least one layer of chorion and at least one layer of cellularized amnion.

5. The method of claim 4 , wherein the surgical procedure comprises a posterior approach spinal procedure.

6. The method of claim 5 , wherein the posterior approach spinal procedure is a laminectomy or discectomy.

7. The method of claim 5 , wherein the posterior approach spinal procedure is an Anterior Lumbar Interbody Fusion (ALIF) or Transforaminal Lumbar Interbody Fusion (TLIF).

8. The method of claim 4 , wherein the surgical procedure comprises an anterior approach spinal procedure.

9. The method of claim 4 , wherein the surgical procedure comprises a lateral approach spinal procedure.

10. A method for regenerating and/or repairing tissue in a subject, the method comprising applying to the tissue in need of regeneration and/or repair a placental tissue graft produced by the method comprising:
a) laminating at least two placental tissues together;
b) chemically dehydrating the placental tissues; and
c) freeze-drying the placental tissues to produce the tissue graft,
wherein the at least two placental tissues are selected from the group consisting of: (1) at least two layers of chorion, (2) at least two layers of cellularized amnion membrane, and (3) at least one layer of chorion and at least one layer of cellularized amnion; and
wherein the method for regenerating and/or repairing a tissue is selected from the group consisting of repairing a dural tear, eliminating a frenum pull, regenerating lost patella tissue, repairing damaged Schneiderian membrane in the sinus cavity, regenerating soft tissue around dental implants, performing a vestibuloplasty, repairing periosteum, repairing ruptured or damaged bursa, reinforcing rotator cuffs, performing a tympanoplasty, repairing ocular surfaces, facilitating closure of the vas deferens facilitating closure of anastomosis, patching vasculature and/or cardiac defects, and promoting wound healing after plastic surgery.

11. The method of claim 10 , wherein the placental tissue graft is applied directly to spinal dura, a surrounding region of a spine including nerve roots, or a combination thereof.

12. The method of claim 10 , wherein the placental tissue graft is applied directly to a bone.

13. The method of claim 12 , wherein the bone is a vertebra.

Assignees

• Mimedx Group Inc

Inventors

• Daniel John
• Spencer Randall
• Ray Steven

Classifications

• A61K35/50 Primary

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

• A61L2430/02

  for reconstruction of bones; weight-bearing implants · CPC title

• A61L27/3691

  characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation · CPC title

• A61L2430/16

  for reconstruction of eye parts, e.g. intraocular lens, cornea · CPC title

• A61L27/3604 Primary

  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 title