# US 11,077,147 B2 · Acellular biologic composition and method of manufacture

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- Number: US 11,077,147 B2
- Document ID: US11077147B2
- Status: Granted
- Kind: B2
- Application number: 14/810,003
- Filed: 2015-07-27
- Published: 2017-01-26
- Granted: 2021-08-03
- Earliest claimed: 2015-07-20
- Assignees: Vivex Biologics Group, Inc.
- Applicants: Vivex Biologics Group, Inc.
- Inventors: Timothy Ganey; Wendy W. Weston; Gaëtan Jean-Robert Delcroix
- Web page: https://patentgrep.com/patent/US11077147B2

## CPC

- A61K 35/50: Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
- C12N 5/00: Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor; (plant reproduction by tissue culture techniques A01H4/00)
- C12N 5/0605: {Cells from extra-embryonic tissues, e.g. placenta, amnion, yolk sac, Wharton's jelly}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

A biological composition has a mixture of mechanically selected allogeneic biologic material derived from placental tissue. The mixture has non-whole cellular components including vesicular components and active and inactive components of biological activity, cell fragments, cellular excretions, cellular derivatives, and extracellular components. The mixture including non-whole cell fractions including one or more of exosomes, transcriptosomes, proteasomes, membrane rafts, lipid rafts. The mixture is compatible with biologic function.

## Claims

### Claim 1

An implantable acellular freeze-dried biological composition comprising:
a mixture of mechanically selected biologic material derived and separated from placental tissue wherein the mixture and whole cells taken directly from the placental tissue has the whole cells deliberately removed to form the mixture having non-whole cellular components including vesicular components and active and inactive components of biological activity, cell fragments, cellular excretions, cellular derivatives, and extracellular components; wherein the mixture having the non-whole cellular components is further filtered by filtration consisting of filtering through a 0.45 micron filter; wherein the mixture is compatible with biologic function to support new tissue formed independent of mesenchymal cells and further includes a select number of non-whole cell fractions including one or more of exosomes, transcriptosomes, proteasomes, membrane rafts, lipid rafts;
a polyampholyte protectant configured for direct implantation;
and wherein the composition is freeze-dried and has the mixture added to the polyampholyte protectant at ambient temperature prior to freeze-drying which forms a polyampholyte protectant physical gradient in the mixture and the mixture and polyampholyte protectant is thereafter freeze-dried forming the freeze-dried composition, which after freeze-drying the composition is diluted for direct implantation into a patient.

### Claim 2 (depends on 1)

The implantable acellular biological composition of claim 1 further comprises non whole materials including matrices, membranes, and materials added to the mixture derived from placental tissues.

### Claim 3 (depends on 1)

The implantable acellular biological composition of claim 1 wherein the combination of non-whole cell components with a select number of the non-whole cell fractions sustains pluripotency in both graft or host cells or combinations thereof.

### Claim 4 (depends on 1)

The implantable acellular biological composition of claim 1 wherein protectant in the mixture additionally creates an electrical or chemical gradient or combination thereof for tissue regeneration.

### Claim 5 (depends on 4)

The implantable acellular biological composition of claim 4 wherein the gradient has a physical characteristic such as modulus or topography.

### Claim 6 (depends on 1)

The implantable acellular biological composition of claim 1 wherein the mixture is kept at ambient temperature prior to adding the protectant and freeze-drying.