Allografts 101

Question 1

What is bone grafting?

Answer 1

The healing of two bones to one another.
(Stops motion and thereby pain.)
Or to fill a void (restore bone strength)

Question 2

What are the two primary types of grafts?

Answer 2

Structural-struts, shafts, etc…

And osteobiologics - more regenerative and not structural

Question 3

What are the reasons for bone grafting? 5

Answer 3

Trauma
Degeneration
Osteolytic Neoplasm - destructive tumor
Iatrogenic - caused by surgery
Implant failure - joint reconstruction failure

Question 4

Whats the bone graft market in 2017

Answer 4

2.3 Billion
80% spine
10-15% foot and ankle
Average age for fusion is 54.2

Question 5

What 3 characteristics does autograft provide?

Answer 5

1. Scaffold - provides structure to guide the formation of new bone
2. Signal - Naturally occurring growth factors recruit host cells and guide the formation of new bone
3. Cells - Host cell population to support bone growth

Question 6

Why was allostem developed?

Answer 6

To approximate the desired qualities of autograft bone

Question 7

What are the 3 characteristics of allostem?

Answer 7

1. Cells - Replace natural cell population to support bone growth
2. Scaffold - Allograft bone provides ideal structure to guide the formation of new bone.
3. Signal - Naturally occurring growth factors present in allograft bone recruit host cells and encourage the formation of new bone

Question 8

Types of autograft

Answer 8

Source: patient
Iliac crest
Spinous process

Question 9

Types of Demineralized Bone Matrix Putty

Answer 9

Source: Allograft donor
AlloFuse
Grafton
DBX

Question 10

Types of Demineralized Bone Fibers

Answer 10

Source: Allograft Donor
3Demin
Vesuvis

Question 11

Types of Synthetics

Answer 11

Source: Various
ViToss
TCP
HA

Question 12

Types of Bone Morphogenic Protein

Answer 12

Source: Grown in mammalian model

InFuse

Question 13

Types of Cellular Allograft

Answer 13

Source: Allograft donor
AlloStem
OsteoCel
Trinity

Question 14

Types of Bone Marrow Aspirate

Answer 14

Source: Patient
ProCuRE
Retrieve

Question 15

Types of Platelet Rich Plasma

Answer 15

Source: Patient
Harvest
Angel

Question 16

Amniotic Derived Cells

Answer 16

Source: Allograft donor
BioD
NuCel

Question 17

What are Embryonic Stem Cell characteristics?

Answer 17

Harvested from human embryos
Pluripotent - can become any type of cell
Uncontrolled growth an issue
Can become liver, spleen, kidney, etc…

Question 18

What are Adult Stem Cell characteristics?

Answer 18

Recovered from adult tissue
Multipotent
Limited growth
Can only differentiate into fat, cartilage or bone

Question 19

What is a mesenchymal stem cell?

Answer 19

1. Capable of repairing and/or differentiating into fat, cartilage/muscle, or bone
2. Can be transplanted from donor to recipient without stimulating and immune response
3. Must be able to attach to a viable substrate

Question 20

How are cells and DBM substrate combined?

Answer 20

Single donor
Adipose recovery/washing
Enzymatic digestion
Centrifutgation

/

Cancellous bone recovery
Demineralization process

/

Combined cells onto bone grafts
Cell selection and bonding
Rinse
Cryopreservation

Question 21

How many products have a super concentration of mesenchymal stem cells adhered to a demineralized bone scaffold?

Answer 21

Only 1 - Allostem

Question 22

How do we know that it’s MSC that are adhering to the DBM?

Answer 22

Defined by the International Society of Cellular Therapy to have 3 characteristics

1. must adhere to scaffold
2. Must stain positive for certain surface markers
3. Must be able to differentiate into bone, fat or cartilage cells

Question 23

How many MSC’s per cc in Allostem?

Answer 23

66,255k

Question 24

How many MSC’s do you need per cc of cellular allograft?

Answer 24

We don’t know

One study suggested 30k per cc

Question 25

Allostem vs. Bone Marrow Aspirate concentration

Answer 25

Allostem 66k | Bone-Marrow Aspirate BMAC 2500/cc upon implantation

Question 26

Allostem lacks immunogenic components

Answer 26

Our adipose cell concentration, or stromal vascular fraction, contains MSC's, leukocytes, erythrocites, etc Allostem combines the SVF onto the bone graft MSC's adhere to the substrate Therefor most immunogenic components wash off in the rinse leaving behind a high concentraiton of MSC's that adhere to the bone.

Question 27

How do we know MSC's adhered and the immunogenic components rinsed off?

Answer 27

We took a picture under a high powered microscope

Question 28

What are leukocytes?

Answer 28

White Blood Cells are the cells of the immune system that are involved in defending the body against both infectious disease and foreign invaders.

Question 29

What are erythrocytes?

Answer 29

Red blood cells, also called erythrocytes, are the most common type of blood cell and the vertebrate organism's principal means of delivering oxygen to the body tissues via the blood flow through the circulatory system.

Question 30

What do MSC's on allostem Show?

Answer 30

Strong osteogenic proliferative ability

Question 31

Adipose cells vs Bone Marrow Cells

Answer 31

Equally good at producing bone They both contain MSCs The difference is there are many more MSCs in Adipose tissue when compared to Bone Marrow Cells. Typical bone marrow will have 250,000 MSCs and Adipose will have 18,000,000 MSCs from Adipose

Question 32

Even in ideal conditions, what needs time to adhere to the scaffold?

Answer 32

MSCs | Important when considering irrigation

Question 33

How long is typical graft prep?

Answer 33

10-15 minutes | Only 6.2% will stick to the desired scaffold

Question 34

What type of scaffold does Allostem use?

Answer 34

Nature's scaffold | Cells prefer the naturally occuring boney nanostructure to synthetics by nearly 2x the rate of leading synthetics

Question 35

Does Allostem adapt to different cage designs?

Answer 35

Yes. Whether you perform cervical, deformity, MIS, lateral, stand-alone, etc, Allostem has a product to fit their needs

Question 36

What does demineralization create?

Answer 36

A more biologically active graft with all-natural growth factors in quantities safe for bone growth

Question 37

Where are BMPs found?

Answer 37

Naturally in demineralized bone

Question 38

What are the BMPs key in growing new bone?

Answer 38

BMP 2 and BMP 7

Question 39

How long has DBM been used?

Answer 39

40+ years

Question 40

What type of BMP is InFuse?

Answer 40

rhBMP

Question 41

What are the down sides of InFuse?

Answer 41

Can create too much bone growth | Linked to a number of cancer, ectopic bone growth and sterility

Question 42

How much more BMP is there in rhBMP than in standard DBM?

Answer 42

1,000,000x more

Question 43

What is the Allostem quality process?

Answer 43

``` Tissue donation Rigorous donor screening Rigid recovery procedures Extensive donor testing Aseptic processing Post-processing review Terminal sterilization - where appropriate Allograft distribution ```