amniocyte plus tm - predictive biotech · mesenchymal stem cell attributes viable msc: plastic...

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Revolutionary Regenerative Therapeutic Product Portfolio Predictive Biotech tissue sources and product contents. Tissue Source Products Fetuin-A Interleukin 37 Macrophage Colony Stimulating Factor Serpin A4 Syndecan - 4 Bone Morphogenic Protein - 7 Complement Component 5a Fibroblast Growth Factor Platelet Derived Growth Factor - AA Thrombospondin - 2 Adhesion G Protein Collagen 1, 2, 3 Elastin Fibronectin Hyaluronic Acid Cystatin - B Galectin - 9 Granulysin Lipocalin - 2 Intracellular Adhesion Molecule 1 Placenta Placenta Umbilical Cord Umbilical Cord Cytokines ISCT Standards AmnioCyte Amniotic Fluid Allograft AmnioCyte Plus Amniotic Matrix Allograft TM TM TM TM CoreCyte PolyCyte Wharton’s Jelly Allograft Wharton’s Jelly Allograft Mesenchymal Stem Cells (MSC) Biologically Young Source Viable MSC Cell Count Positive Expression of CD73 Positive Expression of CD90 Positive Expression of CD105 Lack Expression of CD14 Lack Expression of CD34 Lack Expression of CD45 Lack Expression of HLA-DR Lack Expression of CD19 Viable MSC: Plastic Adherent Mesenchymal Stem Cell Attributes Predictive Biotech’s products are processed from donated human tissue from full term deliveries in accordance with FDA guidelines. Predictive Biotech’s products are regulated as a human cell, tissue, or cellular or tissue-based products (HCT/P) under 21 CFR Part 1271 and Section 361 of the Public Health Service Act. All of Predictive Biotech’s human cell and tissue products are intended for homologous use. Number of check marks reflect relative factor amounts as compared to other Predictive Biotech products. All data represented on this grid is informed by either or all available literature, external validation and internal testing. Empty data fields indicate quantities either found in trace amounts, or quantities not specified in literature. Citations and references on file with Predictive Biotech. Scaffolding Cytokines Homeostatic Cytokines Growth Factor Cytokines General Cytokines MKT-0025, 28 May 2019

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Page 1: AmnioCyte Plus TM - Predictive Biotech · Mesenchymal Stem Cell Attributes Viable MSC: Plastic Adherent ISCT Standards International Society for Cellular Therapy Minimal criteria

R e v o l u t i o n a r y • R e g e n e r a t i v e • T h e r a p e u t i c

Product Portfolio

Predictive Biotech tissue sources and product contents.

R e v o l u t i o n a r y • R e g e n e r a t i v e • T h e r a p e u t i c

AmnioticFluid

LipoaspirateBone MarrowAspirate

AmnioticMatrix

AmnioticMembrane

Platelet RichPlasma

Umbilical CordMatrix

Platelet Rich Plasma - Heated

Umbilical CordBlood

Steroid, NSAID,Synthetic HA...

Peripheral BloodPharma Placenta Umbilical Cord Bone Marrow Adipose Tissue Source

Products

Fetuin-A

Interleukin 37

Macrophage Colony

Serpin A4

Syndecan -4

Bone Morphogenic Protein - 7

Complement Component 5a

Fibroblast Growth Factor

Platelet Derived Growth Factor

Thrombospondin - 2

Adhesion G Protein

Collagen 1,2,3

Elastin

Fibronectin

Hyaluronic Acid

Cystatin - B

Galectin - 9

Granulysin

Lipocalin - 2

Syndecan - 4

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MS

CG

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Mesenchymal Stem Cells (MSC)

Viable MSC Counts

Biologically Young Source

Tissue

SignalingPathway forCytokines

New TissueRecruitedTissue

Cytokines Cytokines

PBIO-DOC-CYTOGRID, v1,10/30/2017

AmnioticFluid

LipoaspirateBone MarrowAspirate

AmnioticMatrix

AmnioticMembrane

Platelet RichPlasma

Umbilical CordMatrix

Platelet RichPlasma - Heated

Umbilical CordBlood

Steroid, NSAID,Synthetic HA...

General Cytokines

Growth Factor Cytokines

Scaffolding Cytokines

Homeostatic Cytokines

Peripheral BloodPharma Placenta Umbilical Cord Bone Marrow Adipose Tissue Source

Products

Mesenchymal Stem Cells (MSC)

Biologically Young Source

Viable MSC Cell Count

Positive Expression of CD73

Positive Expression of CD90

Positive Expression of CD105

Lack Expression of CD14

Lack Expression of CD34

Lack Expression of CD45

Lack Expression of HLA-DR

Viable MSC: Plastic AdherentMe

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ISCT StandardsInternational Society for Cellular Therapy

Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement

Authors: Dominici MD, K. Le Blanc, Mueller, Slaper-Cortenbach, CMarini, D.S.Krause, R.J.Deans, A.Keating, D.J.Prockop, E.M.Horwitz

The considerable therapeutic potential of human multipotent mesenchymal stromal cells (MSC) has generated markedly increasing interest in a wide variety of biomedical disciplines. However, investigators report studies of MSC using different methods of isolation and expansion, and different approaches to characterizing the cells. Thus it is increasingly difficult to compare and contrast study outcomes, which hinders progress in the field.

To begin to address this issue, the Mesenchymal and Tissue Stem Cell Committee of the International Society for Cellular Therapy proposes minimal criteria to define human MSC.

1. MSC must be plastic-adherent when maintained in standard culture conditions 2. MSC must express CD105, CD73 and CD90, and lack expression of CD45, CD34, CD14 or CD11b, CD79α or CD19 and HLA-DR surface molecules 3. MSC must differentiate to osteoblasts, adipocytes and chondroblasts in vitro

While these criteria will probably require modification as new knowledge unfolds, we believe this minimal set of standard criteria will foster a more uniform characterization of MSC and facilitate the exchange of data among investigators.

Positive Expression Plastic-Adherent in Standard Cultures

MSC Must Differentiate

Negative Expression

Adipocytes

OsteoblastsChondroblasts

CD73 CD90 CD105

CD14 CD34 CD45

CD19 HLA-DR

MSC

Cyto

kin

es

PBIO-DOC-ISCTGRID, v1,10/30/2017

Tissue Source

Products

Fetuin-A

Interleukin 37

Macrophage Colony Stimulating Factor

Serpin A4

Syndecan - 4

Bone Morphogenic Protein - 7

Complement Component 5a

Fibroblast Growth Factor

Platelet Derived Growth Factor - AA

Thrombospondin - 2

Adhesion G Protein

Collagen 1, 2, 3

Elastin

Fibronectin

Hyaluronic Acid

Cystatin - B

Galectin - 9

Granulysin

Lipocalin - 2

Intracellular Adhesion Molecule 1

PlacentaPlacenta Umbilical CordUmbilical Cord

Cy

tokin

es

ISC

T S

tan

dard

s

AmnioCyteAmniotic Fluid Allograft

AmnioCyte PlusAmniotic Matrix Allograft

TM TM TM TM

CoreCytePolyCyte Wharton’s Jelly Allograft Wharton’s Jelly Allograft

Mesenchymal Stem Cells (MSC)

Biologically Young Source

Viable MSC Cell Count

Positive Expression of CD73

Positive Expression of CD90

Positive Expression of CD105

Lack Expression of CD14

Lack Expression of CD34

Lack Expression of CD45

Lack Expression of HLA-DR

Lack Expression of CD19

Viable MSC: Plastic Adherent

Me

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Att

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Predictive Biotech’s products are processed from donated human tissue from full term deliveries in accordance with FDA guidelines. Predictive Biotech’s products are regulated as a human cell, tissue, or cellular or tissue-based products (HCT/P) under 21 CFR Part 1271 and Section 361 of the Public Health Service Act. All of Predictive Biotech’s human cell and tissue products are intended for homologous use.

Number of check marks reflect relative factor amounts as compared to other Predictive Biotech products. All data represented on this grid is informed by either or all available literature, external validation and internal testing. Empty data fields indicate quantities either found in trace amounts, or quantities not specified in literature. Citations and references on file with Predictive Biotech.

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MKT-0025, 28 May 2019