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Methods and articles of manufacture for the treatment of animals

a technology of animal and article manufacture, applied in the field of methods and articles of manufacture for the treatment of animals, can solve the problems of animal and human injuries that are difficult to treat, animal or individual in jeopardy with potential loss of function, failure to adequately, etc., and achieve the effect of promoting healing and promoting healing

Pending Publication Date: 2018-11-08
ANICELL BIOTECH LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0007]The fetal tissue and cellular compositions disclosed herein have many advantages for use in promoting healing of injuries including immune privilege, an absence of associated ethical issues, and no requirement of invasive procedures for harvesting the cells and tissues. In addition, the treatment regimen disclosed herein is remarkably effective at promoting the rapid healing of open wounds within one to two weeks.
[0008]One embodiment is directed to an article of manufacture. The article comprises a dried particulate mixture of mechanically decellularized amnion obtained from one or more animals compatible with a subject animal. The dried particulate mixture is capable of reconstitution to form a reconstituted medicament for administration to the subject animal to promote healing.
[0018]A further embodiment of the kit comprises fetal cells obtained from one or more animals compatible with a subject animal that are compatible with a particulate mixture obtained from the mechanical decellularization of amnion isolated from one or more animals. The fetal cells are applied in cooperation or concurrently with the reconstituted medicament or form a combined medicament comprising a particulate cellular suspension and / or amniotic liquid medicament for administration to the subject animal to promote healing.
[0019]A further embodiment of the kit comprises a tissue wrap obtained from one or more animals compatible with a subject animal. The tissue wrap comprises amnion tissue constructed and arranged for placement in juxtaposition with the site of injury. The tissue wrap is applied in cooperation or concurrently with the reconstituted medicament or a combined medicament comprising a particulate cellular or acellular suspension medicament with or without mechanically decellularized amnion and / or amniotic liquid for administration to the subject animal to promote healing.
[0026]A further embodiment is directed to a method of making a particulate cellular suspension medicament. The method comprises the steps of providing a dried particulate mixture of mechanically decellularized amnion obtained from one or more animals compatible with a subject animal, and fetal cells obtained from one or more animals compatible with a subject animal to form a particulate cellular suspension medicament and forming a particulate cellular suspension. The particulate cellular suspension medicament is administered to a subject animal to promote healing.

Problems solved by technology

Wounds and injuries in animals and humans can sometimes be difficult to treat.
Failure to adequately treat and promote healing can place the animal or individual in jeopardy with potential loss of function in an effected limb or amputation, or even loss of life.

Method used

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  • Methods and articles of manufacture for the treatment of animals
  • Methods and articles of manufacture for the treatment of animals
  • Methods and articles of manufacture for the treatment of animals

Examples

Experimental program
Comparison scheme
Effect test

example 1

Material Processing

[0078]This procedure defines the aseptic collection of amniotic material (amnion and amniotic fluid) for injection at the site of an injury.

[0079]Amnion Tissue

[0080]The amnion container was picked up and sampled for Bioburden. The amnion was aseptically transferred into the sterile field (laminar flow hood). The amnion transport packaging (previously disinfected, i.e. with 70% ETOH) was opened.

[0081]A 50 mL sample of the Amnion Transport Solution was aseptically transferred into a 30 to 60 mL conical tube for pre-processing bioburden testing. The vial was labeled with sample description, batch number, date and time and placed in a designated refrigerator.

[0082](1) Amnion Preparation

[0083]The amnion from the incoming container was transferred into approximately 200 mL of Plasma Lyte-A in a sterile bioassay dish where it was gently rinsed. A piece of amnion was then spread evenly on a sterile cutting board carefully avoiding any overlaps. A record was made of the am...

example 2

rocessing of the Amniotic Material

[0093](1) Aseptic Cryofractionation of Amnion

[0094]After at least one hour, the amnion was removed from the drying rack and transferred into the milling chambers having an impactor. The milling chambers were placed into the Cryomill and cryofractionated using the following settings:

[0095]Number of Cycles: 4

[0096]Frequency 1 / s: 10 CPS—

[0097]Precooling Time: 10 minutes

[0098]Grinding Time: 4 minutes

[0099]Intermediate Cooling: 3 minutes

[0100]Once grinding was complete, the milling chambers were allowed to warm to room temperature for approximately two hours. The start and stop times were recorded.

[0101]Approximately 50 mL of the amnion suspension solution was dispensed into each milling chamber. The inside milling chamber and the impactor were rinsed with the solution multiple times until the ground amnion (dried particulate mixture) was re-suspended and collected in the bottom of the chamber. The impactor was removed using the magnet pen. The cryofract...

example 3

Tissue Wrap Preparation

[0111]After confirming the amniotic tissue source and donor mare ID and recording the time of receipt, the amnion transport packaging (previously disinfected, i.e. with 70% ethanol, methanol, etc.) was aseptically transferred into the sterile field (a laminar flow hood). A sample of the Amnion Transport Solution was first transferred into a 50 mL conical tube for Bioburden testing. The vial was then labeled with sample description, batch number, date and time and placed in designated refrigerator.

[0112](1) Amniotic Membrane Wrap Preparation

[0113]Saline was aseptically added into a second receiving pan in the sterile field (i.e. laminar flow hood) and the amnion tissue was taken from incoming receiving pan to the second receiving pan containing the sterile saline. Any remaining blood was rinsed with sterile saline. After documenting the amnion preparation start time, sterile gauze or laps was used to remove any remaining debris / blood from the surface of the amn...

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Abstract

Methods are disclosed for the collection and processing of amniotic material in animals. These methods involve collection of amniotic material directly during parturition or caesarian section in animals for the processing of regenerative wound treatments and tissue repairs without culturing or utilization of any excess manipulation of tissue.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority to U.S. Provisional Application 62 / 234,354, filed Sep. 29, 2015, entitled “Methods and Articles of Manufacture for the Treatment of Animals, the contents of which are incorporated herein by reference in their entirety.STATEMENT REGARDING FEDERAL SPONSORSHIP[0002]Inventions described herein were not conceived or reduced to practice with Federal sponsorship.FIELD OF THE INVENTION[0003]The present disclosure provides processed fetal tissues and cells suitable for promoting healing and methods of using these fetal tissues and cells to promote healing at the site of an injury.BACKGROUND OF THE INVENTION[0004]Wounds and injuries in animals and humans can sometimes be difficult to treat. Failure to adequately treat and promote healing can place the animal or individual in jeopardy with potential loss of function in an effected limb or amputation, or even loss of life.[0005]It would be useful to have methods and a...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K35/50A61K9/00A61K9/08A61K35/54A61K45/06A61K9/06A61L15/40A61L15/44A61L27/26A61L27/36A61L27/38A61L27/54
CPCA61K35/50A61K9/0019A61K9/08A61K35/54A61K45/06A61K9/06A61K9/0048A61L15/40A61L15/44A61L27/26A61L27/3604A61L27/3804A61L27/54A61K2800/412A61K9/0051A61K8/0212A61K8/0241A61K8/982A61Q19/08
Inventor AMES, BRANDONBARCELO-FIMBRES, MOISES
Owner ANICELL BIOTECH LLC
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