What patients are best candidates for stem cell therapy for arthritis of the knee, hip, shoulder and ankle.

1. Qualifying for Cell
Therapy
Edward G. Loniewski, DO , FACOS, FAOAO
Brighton, Michigan
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2. Detroit- The Birthplace of:
•Motown Sound- Barry Gordy
•Techno- Derrick May, Kevin
Saunderson and Juan Atkins
•Punk – MC5, Iggy Pop, Radio Birdman,
Death (First all Black Punk),
Degenerates
•Funkadelic- Parliament, George
Clinton.
•Early Rock- Bill Haley, Del Shannon
•Garage Rock- Suzi Quartro, Patti
Smith, Ted Nuggent, Glen Frey. Gretta
Van Fleet.
•Glam Rock- Alice Cooper
•The Queen of Soul- Aretha Franklin
•Creem Magazine – “America’s Only
Rock and Roll Magazine.”

3. And…. Dancing with the Stars
Dru Dunworth
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4. Famous Panel of Experts
Godfather of Bone Marrow Carlton
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5. Learn New
Stuff!
https://youtu.be/HvQZ-4hasUk

6. Summary Points
• Cell therapy corrects biochemical
problems
• Cell therapy is chosen by exclusion and
absence of:
• Bone and blood disease
• Mechanical disease
• Referred pain
• Unrealistic expectations
• Review ALL options and make a shared
decision
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7. Disclosures
• Consultant for Celling Biosciences – ART BMC™ - Austin, Tx.
2015- Present
• Consultant, Principle Investigator and Stockholder- Augmenstem™
and Plenastem™ AVM Biotechnology- Seattle Wa.- 2016- Present
• Former Consultants for:
• Biomet Biologics – GPS system
• Lilly – Forteo
• Bionicare – PEMF Knee brace
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8. What are cell based therapies?
• Types -
• — somatic cell technologies
• — cell immortalization technologies
• — ex vivo gene modification of cells using viral vector
technologies
• — in vivo gene modification of cells using viral vector
technologies
• — genome editing technologies
• — cell plasticity technologies
• — three-dimensional technologies
• — combinations of the above
• Orthopedics will normally use Somatic Cell Technologies:
• This technology uses cells from the human body that are purified,
propagated and/or differentiated to a specific cell product that
subsequently is administered to a patient for a specific therapeutic
treatment without further technological input.
• Components for use in orthopedics
• Platelets
• Plasma proteins
• Stem cells
• Chondrocytes – ACI
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9. REDUCE
IL-1B
REGENERATE
Normal
Homeostasis
RESTORE
CELL TO CELL
COMMUNICATION
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10. BMC is for Biochemical problems and not
Biomechanical
• Biomechanical:
• Meniscus tears
• Ligament tears
• Severe malalignment
• Biochemical Changes
• Cytokines
• Interleukins – IL-1b
• MMP
• TGF-b
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11. Qualifying is a process of elimination
Lack of the following:
• Bone Disease
• Blood Disease
• Mechanical symptoms
• Disease of joint above or below
• Proper patient expectations
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12. Contraindicated
Conditions
• Lymphoproliferative disorders:
• CLL
• Hodgkin and Non-Hodkin
• Hairy cell
• Myeloproliferative disorders ( CML, Polycythemia Vera, Essential
thrombocythemia & Myleofibrosis)
• Myelodysplastic syndromes ( Anemia, thrombocytopenia and neutropenia)
• Multiple Myeloma
• Cytopenia, thrombocytosis, leukocytosis, and unknown chronic anemia
• Fungal infections, tuberculosis, and other granulomatoses.
• Previous Radiation therapy to pelvis (rare to radiate PSIS)
• Active Cancers
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13. Conditions which need
additional treatment
• Meniscal tears- symptomatic (2 or more
giving away/week)
• ACL Tears in K-L Grade 2 or less knees
which are symptomatic
• Bone Marrow Lesions/ AVN
• Symptomatic Loose Bodies
• Lateral tracking Patellar-femoral joint
• Large-symptomatic Popliteal Cysts
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14. Conditions which make little difference in
outcome
• BMI
• DM
• CAD
• Post-traumatic arthritis
• Patellar-femoral pain
• Previous septic arthritis
• Current and past narcotic
abuse
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15. Conditions We Don’t
Know Enough About
• Inflammatory arthritis
• Gout
• RA
• Diabetic Neuropathy (may
require subchondroplasty and
Medial sleeve injection )
• Workman’s Comp.
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16. Cell Based Therapy only corrects the BioChemical
Joint and Not the BioMechanical Joint
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17. Mechanical Axis
• Mechanical Axis of the Lower
Extremity:
• Line Drawn from Center of Hip to
Center of Ankle.
• Always a straight line and normally
just passes to medial to the tibial
spine of the knee.
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18. Anatomic Axis
• The line drawn into the
center of the femur
and tibia and
intersecting at the
center of the knee.
• Normally the tibial
anatomic and
mechanical are grossly
the same, however
• Femoral anatomic axis
is 4-8 degrees lateral
to the mechanical with
the average being 6
degrees.
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19. Tibial-Femoral Angle
• On a weight-bearing
radiograph, the lateral angle
between the anatomic axes of
the femur and the tibia is
called the femorotibial angle
(FTA) [21].
• The average femorotibial angle
is approximately 178° in men,
and 176° and 174° in Asian and
Caucasian women, respectively
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20. Classic Technique
for Reading
Radiographs
• Ken Krackow, MD –
Online at :
https://pdfs.semantics
cholar.org/7a22/c1554
709a1fdab4995df4a44a
6d8b42e5e96.pdf
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21. Subluxation
• Joint Subluxation is when the
femur starts to slide off the
tibia.
• This can be due to:
• Translation of tibial-femoral
rotation
• Collapse of the subchondral tibial
plate.
• Complete loss of meniscal height
and integrity
• Ligament incompetency
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22. Subluxation
• Usually accompanies:
• Loss of motion of the joint
• Flexion contractures
• Lack of any passive correction of
deformity ( unable to use
unloader brace)
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23. Severity of Arthritis
• Kellgren- Lawrence grading
alone has little effect on the
outcome of cell based
therapies given the absence of
other criteria.
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24. Loss of Motion
• Cartilage metabolism is
dependent upon:
• Motion of synovial fluid
• Motion of the joint
• Life is motion….motion is
life.
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25. Frequent
Effusions
• Effusions may be related
to:
• Gout
• Inflammatory Arthritis
• Loose Bodies or Large
Meniscal Tears
• Excessive production of
cytokines (ie IL-1B, IL-
6)
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26. Instability
Episodes
• Instability episodes of a
joint may indicate:
• Symptomatic
Meniscus – Giving
away 2 or more
times a week.
• Loose body
• ACL/ MCL tears
• Two or More
Episodes per Week
indicates a
mechanical problem
with the knee.
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27. Bone Marrow
Lesion
• T2 weighted MRI-
• Usually medial tibia
• Related to stress
fracturing of
subchondral bone
• Presence means high
risk for progressive
pain and eventual joint
replacement.
• Does not disqualify
patient from BMC but
needs to be treated.
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28. Treating Bone Marrow Lesion
• BML should be addressed with
Bioplasty (subchondroplasty).
• Jamshidi needle placement
into area of inflammation.
• Decompress
• Replace with Bone Marrow
aspirate and BMC
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29. Summary of Biomechanical Factors Not
Correctable with Cell Based Therapy
• Tibial femoral angle more than 10 degrees of Varus or 8 degrees of
Valgus.
• Subluxation
• Giving away – 2 or more times per week.
• Loss of 20 degrees of total normal motion.
• Effusion requiring aspirations 4 or more times per year.
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30. Exceptions to this rule:
• Nonmaleficence (do no harm) Obligation not to
inflict harm intentionally;
• In medical ethics, the physician's guiding maxim is “First, do no
harm.” Beneficence (do good) Provide benefits to persons and
contribute to their welfare.
• Thus, when the risk of traditional treatment (ie Joint
Replacement) provides an undue risk, conservative measures are
justified.
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31. Major Risk Factors for Joint Replacement
Two or More of the following may indicate increased risk for joint replacement surgery:
• Body Mass Index over 40
• Major Depression
• Chronic use of narcotics
• Active Renal Failure
• Active Hepatitis or liver disease
• Frequent DVT/PE history
• Previous surgical infections
• Diabetes with HgA1c above 8
• Stroke history
• Active heart disease causing heart failure
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32. Social and Ethical Barriers for Joint
Replacement
• Patient is unwilling to consent for surgery
• Unable to provide 24/7 care at home for at least 2 weeks.
• Unable to take at least 2 weeks off from work for the care of
another loved one.
• Unwilling to participate in pre-operative and post-operative care
such as medical clearance and physical therapy.
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33. • Stem Cell Intake Form
• Does your joint feel unstable such as giving away or a feeling
you cannot trust this joint? (This is not stiffness, but actual
catching causing you to lose balance)
• Yes
• No
• If yes, how often:
• Rarely (less than 1 x month)
1 pt
• Sometimes (1-4 x month)
2 pts
• Frequently (2 or more times per week)
3 pts
• Have you ever had fluid drained from your joint?
• Yes
• No
• If yes, how often
• Rarely (less than 1 x year)
1 pt
• Sometimes (1-2 x year)
2 pts
• Frequently (more than 3 x per year)
3 pts
• Do you have loss of motion of your joint?
• Yes
• No
Stem Cell Scoring
• If Yes, how much?
• Minimal- you can fully straighten your joint so it is flat on a bed and bend this enough to easily dress
and push yourself out of a chair 1 pt
• Moderate- you have trouble making your leg straight but can still do this and have trouble dressing
yourself and getting out of a chair 2 pts
• Severe- you have to place a pillow under your leg and cannot put on your own shoes or clothes and
someone normally helps you get out of a chair) 3 pts
• The following is for knees only.
• Do your knees bow?
• Yes
• No
• If yes, how much?
• Minimal- when you stand in a mirror without your pants, you notice that you are bow legged or knock
kneed. 1 pt
• Moderate- You notice that you are bowed even with your pants on. pts
• Severe- Your friends and family members suggest you joint the rodeo or tell you to get your joint
• fixed before it breaks. 3 pts
• Am I a candidate for office based stem cell therapy?
• 0-6 points - Yes
• 7-8 points- Maybe pending further face to face evaluation.
• 9 points - No pending that you cannot have a joint replacement – see below
Any patients with scores of 8 or below should be scheduled for a stem cell evaluation. Patients with
scores of 9 or above should go to the next section.
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34. Joint Replacement Risk Scoring
• Should I have my Joint Replaced?
• This is a series of questions to determine your risk for joint
replacement. This is not an exact science, but is a tool to determine
risk with surgery. The following medical and social risk factors help
determine if you are an ideal candidate. Your overall health- Do
you have any of the following conditions:
• Weight over 250 lbs 2 pts
• Previous infections after surgery or staph skin infections 2 pts
• History of blood clots in your legs or lungs 2 pts
• Family history of frequent blood clots in their legs or lungs 1 pt
• Chronic Pain history and currently taking narcotic medications 1 pt
(more than 4 narcotic pain pills per day)
• Current depression treated with medications. 1 pt
• Diabetes treated with medications (not diet controlled) 1 pt
• Heart Failure (not heart attack, but weakness of the heart) 2 pts
• Active Liver diseases or Hepatitis B or C 3 pts
• Kidney failure 3 pts
These are social questions to determine if you have enough support
and are willing to accept the responsibilities of a joint replacement
surgery. Only No Answers will be scored.
Are you willing to have your joint surgical replaced?
Yes
No 3pts
Do you have family members or friends available to help you 24 hrs
a day/ 7 days a week for 2 weeks after a joint replacement?
Yes
No 3pts
Are you and your family members able to take at least 2 weeks off
work for the recovery from a joint replacement?
Yes
No 3pts
Are you willing to participate in physical therapy 2-3 week for 6 to 8
weeks?
Yes
No 3pts
Am I a candidate for Joint Replacement Surgery?
Total Points:
0-2 points - Yes
3 points- Maybe
4 points or more- No- but if your medical and social
condition changed, you may.
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35. Review ALL Options for Arthritis
• Do not discuss cell therapy as only option
• Discuss advantages and disadvantages of each
option
• Combined conservative therapies
• Physical
• Weight control
• Medications
• Bracing
• HA
• Steroids
• Discuss surgical options:
• Joint Replacement
• HTO
• Combined conservative with Cell
• PRP
• BMC
• Subchondroplasty (Bioplasty)
• Cell Therapy is a shared decision
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36. Review Patient
Expectations
• What cell therapy does:
• Slowly corrects biochemical imbalance
• Restores homeostasis -
• What cell therapy does not:
• Does not directly grow cartilage
• Does not regenerate new meniscus or
bone
• Does not correct bow or bend
• Does not make you superhuman
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37. Summary Points
• Cell therapy corrects biochemical
problems
• Cell therapy is chosen by exclusion and
absence of:
• Bone and blood disease
• Mechanical disease
• Referred pain
• Unrealistic expectations
• Review ALL options and make a shared
decision
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38. Have Some Fun at this Conference!
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