Post on 07-Apr-2016
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David C. Karli, MD, MBA Steadman Clinic Vail, CO 2015
Medical School: University of Maryland
Residency: Harvard Medical School Board Certified Physical Medicine & Rehabilitation
Practice: Harvard Medical School Faculty
Steadman Clinic (Since 2002)
MBA: University of Denver Daniels School of Business
Work with Regenerative Medical Therapies since 2004
Directly involved in treatment of over 8000 patients Via Injection
Surgical Implantation
Biotech Industry Consultant
Founder – Greyledge Technologies, LLC
Primary clinical/research focus to date: Platelet Rich Plasma
Bone Marrow Blood Concentrate
: is a branch of translational research in tissue engineering and molecular biology which deals with the “process of replacing, engineering or reengineering human cells, tissues or organs to restore or establish normal function.”
Taking nonfunctional tissue and making it functional again using biology Systemic
Nutrition, Sleep, Exercise, Supplementation, Hormone and Metabolic Optimization, Psychological Health
Tissue Specific
Cellular Therapy Therapy in which cellular material is injected
into a patient; this generally means intact, living cells; to achieve a therapeutic effect
Platelet White Blood Cell
Autologous (for this talk)
Tissue obtained from the same individual
Allogeneic
Tissue obtained from another individual
Stem Cell Cell that is capable of
giving rise to indefinitely more cells of the same type, and other kinds of cells Adult (Bone Marrow,
Muscle, Fat)
Embryonic
Placental Derived
Constant: The body will attempt to fix itself Will not always succeed…
Some tissues more “efficient” than others In part – secondary
to blood supply:
Skin, muscle – great efficiency
Tendon, ligament – moderate efficiency
Disc, joint cartilage, meniscus – poor efficiency
Basic conditions for healing:
Energy source Glucose (+/- oxygen)
Building blocks for repair
Amino acids Proteins
Replacement cells
Growth Factors
Light switch
Optimal local environment to facilitate repair
All typically carried/modulated by blood
Manipulation of blood tissue into an implantable product which would augment and amplify the body’s capacity to heal itself
More than clotting agents: Anatomy:
Contractible cytoskeleton Granules : contain GFs,
clotting factors, and numerous proteins
When Activated:
Coordinate healing
Proteins released from injured tissue = trigger for activation
Autologous Biotherapies - Phase I:
Biotherapeutic created by whole blood component separation and concentration of platelets and/or White Blood Cells
Implanted to augment tissue healing
Bio therapeutic created by marrow blood component separation and concentration of platelets and/or White Blood Cell Populations
Delivers complex
collection of cells and bioactive proteins that control maintenance of our body to area of injury or disease to stimulate repair Pluripotent cells “Stem-like” cells Stem cells Platelets
Theories/evidence for therapeutic effect: 1. Cells integrate into native tissue and become new
tissue
2. Cells stimulate native cells to proliferate and become new tissue
3. Cells release proteins to induce healing response
4. Cells regulate the local environment to become less toxic (block inflammation)
5. A combination of the above…
Potential/Demand have driven access to biologic therapies (including “stem cells”) - naturally outpacing scientific validation through research
Access to emerging therapies in fee for service model: Low Barrier to entry
Patient Controlled Care… Patient responsible for researching options for care =
Patient Consumer
Should You Investigate Regenerative Medicine?
What Can You Expect?
Tendonitis/tendonopathy/partial thickness tear Shoulder, Elbow, Hip, Knee, Foot/Ankle
Ligamentous injury/tears (MCL/ACL, Ankle, Elbow) Muscle injury (sprains/strains)/tears Bursitis/ITB Osteoarthritis
Knee, Shoulder, Hip, Ankle, Small Joint Knee Meniscal Tears Hip/Shoulder Labral Tears
Plantar fasciitis Spine?
Disc Regeneration?
Arthroscopy
Knee Hip
Is your problem appropriate for treatment? History and Physical Exam
Here is what we know from: Research Anecdotal Application
Safety and Risk Discussion
Your money is applied to buy an outcome: What is the likelihood of success?
8 out of 10 rule
The treatment may not work!
What will the experience be like?
Cellular Harvest is a technical procedure and not without risk Not routinely taught in standard medical training
programs!
How many has your practitioner performed?
Can they do so comfortably?
Cellular implants are likely to do nothing if not implanted accurately and safely.
Easy to perform injections poorly
Technical procedures – not without risk!
Guided injections require extensive and nonstandard training.
Is your practitioner going to guide the implantation?
How many has he/she done?
Are All Created Equal?
Does your practitioner know exactly what is being implanted?
A majority of PRP and BMC has been implanted without quantitative control!
!PRP#/#BMCC#AUTOLOGOUS#BLOOD#PRODUCT#RECORD#
!
FORM&10036.00!MARCH!2013!!!!!!!!!!!!!©!Greyledge!Technologies,!LLC!2010!!
#
!BMCC#/#PRP#ANALYSIS#!
!Platelet!Concentration!!
!_________________________!!Platelets/µL!
!WBC!Concentration!!
!_________________________!!WBC/µL!
!Neutrophils!!
!_________________________NEU/µL!/_________________%!
!
Lymphocytes!!
!
_________________________LYM//µL!/_________________%!
!
Monocytes!!
!
_________________________MONO/µL!/_______________%!
!
Eosinophils!!
!
_________________________EOS/µL!/_________________%!
!Basophils!
!
!_________________________BASO/µL!/_______________%!
!RBC!Concentration!
!
!_________________________!!RBC/µL!
!BMCC!/!PRP!Volume!
!
!_________________________!!cc!
!BMCC!/!PRP!Concentration!!
!__________________________!!!x!Whole!Blood!
!!!
Place!Patient!Label!Here!!!!
!
DATE:!!
!
!PRP#/#BMCC#AUTOLOGOUS#BLOOD#PRODUCT#RECORD#
!
FORM&10036.00!MARCH!2013!!!!!!!!!!!!!©!Greyledge!Technologies,!LLC!2010!!
!
APPROVAL!SIGNATURES:!
______________________________________________! ________________________!
Technician,!Greyledge!Technologies! ! ! ! DATE!
______________________________________________! _______________________!
VVSC!Designated!OR!Staff!Member! ! ! ! DATE!
By#signing#this#checklist#I#(we)#verify#that#all#information#above#has#been#completed#and#that#the#sample#
Identifiers#match#the#patient#medical#record.#!
!BMCC#/#PRP#WHOLE#BLOOD#ANALYSIS#!
!
Platelet!Concentration!!
!
_________________________!!Platelets/µL!
!
WBC!Concentration!!
!
_________________________!!WBC/µL!
!
Neutrophils!!
!
_________________________NEU/µL!/_________________%!
!Lymphocytes!
!
!_________________________LYM/µL!/_________________%!
!Monocytes!
!
!_________________________MONO/µL!/_______________%!
!Eosinophils!
!
!_________________________EOS/µL!/_________________%!
!Basophils!
!
!_________________________BASO/µL!/________________%!
!RBC!Concentration!!
!_________________________!!RBC/µL!
!Whole!Blood!Volume!!
!_________________________!!cc!
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Education:
What to expect Pain Control
Time to improvement
What to watch out for Emergency Contact
Activity Modification
Therapy/Exercise
Follow Up
Autologous, Point of Care Biologics in my opinion are reasonable and work often for appropriate Indications PRP – soft tissue indications
BMC – OA/cartilage/bony indications
PRP and BMC if performed properly are safe procedures
Accurate standardization/quantification of every product should be a necessity Higher quality research, scientific validation and safety
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firmly believed in: bloodletting: bleeding patients, as well as purges using calomel and
other toxic substances
Some even blamed Rush's bleeding for hastening the death of: Benjamin Franklin, as well as George Washington, and
Rush insisted upon being bled himself shortly before his death
Trivia: Why did some patients survive/recover?
Web Search PRP, BMC and location
Educational Symposium (TOBI)
“stem cell clinical trials for …”
Clinical Trials: Clinicaltrials.gov
Eurostemcell.org
Webmd.com
Nationalstemcellfoundation.org
Blogosphere LinkedIn (BOS)