1. Third Annual Workshop on Legal, Policy, Regulatory, and Ethical Healthspan Extension February 9th Stem Cells and Regenerative Medicine for Aging
ELLIOT B. LANDER , M.D., F.A.C.S.
ELLIOT LANDER MD CO-MEDICAL DIRECTOR AND CO-FOUNDER OF CELL SURGICAL NETWORK CORPORATION AND CALIFORNIA STEM CELL TREATMENT CENTER

2. CSN CELL SURGICAL NETWORK™
Mission: Quality Stem Cell Therapy should be available everywhere and easily accessible
CSN

3. Disclosures Dr. Lander has ownership in: Cell Surgical Network™
California Stem Cell Treatment Center™ in Rancho Mirage and Beverly Hills
Cells On Ice®

5. Hippocrates 5th Century BC “I will apply, for the benefit of the sick, all measures [that] are required,”

6. Rancho Mirage Treatment Center

7. Beverly Hills Treatment Center

9. CELL SURGICAL NETWORK
RESEARCH AFFILIATES OBTAIN TECHNOLOGY AND DATABSE WITH A BRAND LICENSING AGREEMENT
CENTERS COLLECT DATA AND MAINTAIN QUALITY STANDARDS
OVER 120 LOCATIONS IN 16 COUNTRIES WITH 100 IN THE US
OVER 500 PHYSICIANS

10. BIOLOGIC SURVIVAL DEPENDS ON TWO SYSTEMS
DEFENSE AGAINST DAMAGE- OUR IMMUNE SYSTEMS- (WHITE BLOOD CELLS)
HEALING FROM DAMAGE- OUR REPAIR SYSTEMS- (STEM CELLS)
Enemies of survival:
Injuries, radiation, surgery, violence, infection, behavioral (tobacco), overutilization, genetic and epigenetic mental and physical conditions, toxins, cancer, aging.

11. What Is Regenerative Medicine?
Uses stem cells and growth factors
Repair or replace damaged and defective tissues and organs
Create living and functional tissues (not scar)

12. What is a Stem Cell?
These are repair cells that are “looking for a job”
Stem cells can proliferate (replicate into more stem cells)
Stem cells can differentiate (turn into other specific cells or tissues)
These actions are based on signals (Growth Factors) from damaged tissues

13. PATIENTS RECEIVE STEM CELLS AS A DRUG OR AS A SURGERY
Laboratory cultured (manufactured and occasionally engineered) allogeneic stem cells are bottled and administered in a controlled trial or sold off the shelf for FDA approved indications.
Surgeons transfer tissue from a stem cell rich part of the body to a damaged and stem cell deficient area of the body as a lipo-transfer surgical procedure to promote healing .

14. TYPES OF STEM CELLS EMBRYONIC- ethics, tumors
ADULT MESENCHYMAL- bone marrow, adipose, fetal, umbilical
Engineered
IPS

15. Bone Marrow Stem Cells
Mesenchyme stem cells decline with age:

16. ADIPOSE DERIVED STEM CELLS

17. Why Inject Additional Stem Cells?
Stem cell BIOAVAILABILITY- dormant cells made available to damaged tissue
When additional stem cells are added to injured areas in large numbers they can effect therapeutic changes
Can exert local and systemic changes

18. Source of Adult Mesenchymal Stem Cells
ALLOGENEIC- other humans
AUTOLOGOUS- (comes from your own body) so has same DNA as host and can’t be rejected. Lower risk of bacterial or viral infection.
No MHC class II antigens or costimulatory molecules

19. Adult Mesenchymal Stem Cells
Can Form:
Bone
Cartilage
Muscle
Nerve tissue
Blood vessels
Connective tissue
Fat
Other

21. How Do Stem Cells Heal? HOMING PROPERTY-
Cells respond to appropriate cytokine signals released from tissue injury, inflammation, degeneration, disease, or cell death.
ACTIVATION PROPERTY-
Cells promote cytokine mediated paracrine and autocrine effects to repair damaged target tissue. Cells may engraft and trans-differentiate into needed tissue in some cases.

22. PROPERTIES OF SVF BASED ON HOMING AND ACTIVATION
SVF IS REGENERATIVE
SVF IS ANTI-INFLAMMATORY
SVF IS IMMUNO-MODULATORY

23. STROMAL VASCULAR FRACTION
Pre-adipocytes mesenchymal stem cells
Peri-vascular mesenchymal stem cells
Hematopoetic stem cells
Macrophages
T-Reg cells
Endothelial cells
Red Blood Cells
Growth Factors

24. THE “ORCHESTRA”

25. SVF AMPLIFIES THE REPAIR SYSTEM

26. HOW WE PROCURE SVF
“MINI” LIPOSUCTION- UNDER LOCAL ANESTHESIA
“CLOSED” SYSTEM SEPARATION- 70 MINUTES USING 50CC FAT
GMP GRADE COLLAGENASE- WASHED OUT
FILTER 100 MICRONS
PHOTOMICROGAPH/ EVALUATE VIABILITY AND COUNT

28. TIME MACHINE™ CENTRIFUGE

29. TIME MACHINE™ INCUBATOR

31. Filter through 100 micron filters

32. 4

33. FDA Compliant If point of care procedure has No risk of disease transmission
SVF point of care procedure using patient’s own cells
Do not promote therapy or make claims
Performed as a surgical procedure (no laboratory)
IDE application has been submitted to FDA

34. SAFETY
Over 8000 cases performed by Network at our centers with no serious complications

35. SAFETY PAPER ON FIRST 1524 PTS
A Prospective Safety Study of Autologous Adipose Derived Stromal Vascular Fraction Using a Specialized Surgical Processing System.
Principal Authors: Mark Berman MD, Elliot Lander MD,  
Contributing Authors: See Supplemental Table 1: List of affiliates of the Cell Surgical Network have contributed to the database
Published in March 2017 American Journal of Cosmetic Surgery

37. USES OF SVF UNDER IRB Orthopedics Degenerative Diseases
Cardiac Diseases
Pulmonary Diseases
Autoimmune Diseases
Urology
Neurology
Cosmetic Surgery
Ophthalmology
Cancer

38. Orthopedics Spinal disk / Arthritis and Chronic back or neck pain
Ankle
Hip
Knee
Tendons / Ligaments / Sports Injuries
Elbow / Wrist
Shoulder

39. Prior to SVF deployment 4 months after SVF deployment
BEFORE
AFTER
Prior to SVF deployment
4 months after SVF deployment

41. SVF AND HEALING
CONCUSSION DEMENTIA RADIATION DAMAGE PARALYSIS CANCER TREATMENT TRAUMA BONE MARROW DISEASE AGE RELATED DEGENERATION

42. REPLACE PARTS OR BUY A NEW CAR? “CELLULAR REPAIR”

43. CELLULAR REPAIR AND AGING
HOW DO WE MEASURE IT?
IS MEAN TELOMERE LENGTH ACCURATE?
WOULD CELL REPAIR MITIGATE THE PHENOTYPE OF AGING HUMAN BEINGS?
DO WE DIE WHEN WE RUN OUT OF AN ADEQUATE SUPPLY OF OUR REPAIR CELLS?

44. PERSONALIZED MEDICINE IS HERE
Personal line of stem cells expanded from SVF:
Immortalize
Industrialize
Prevention
Intervention

45. TAKING PERSONALIZED MEDICINE TO THE NEXT LEVEL
Screening and detection
Risk stratification
Chemotherapy selection
Pharmacogenomics to choose medications
What about personalized treatment using your own DNA?

46. USE YOUR OWN DNA AS A MEDICINE TO REPAIR CELLS

47. USING YOUR OWN CELLS AS A MEDICINE
Obtain a reserve of your own repair cells with your own DNA.
Allows your own custom dosing schemes based on cell number, treatment interval, deployment method.
Industrialize- expand and force multiply your own repair cells and reserve huge quantities for a potential “surge” when repair needed.

48. “BIO-INSURANCE” A REPOSITORY OF YOUR OWN CELLS IS REAL HEALTH INSURANCE
Repeat treatments for aging and other degenerative conditions
Conditions that require high numbers of cells as a “surge”
Creating customized drugs: antibiotic and cancer agents
Gene therapy
Creating replacement parts (bone marrow and organs)

49. PROBLEM: LIFETIME ACCUMULATION OF CELLULAR DAMAGE
THE NUMBERS GAME
PROBLEM: LIFETIME ACCUMULATION OF CELLULAR DAMAGE
DEMAND VS. SUPPLY
DEMAND FOR REPAIR INCREASE OVER TIME
SUPPLY OF HUMAN REPAIR CELLS (QUALITY AND NUMBER) DECREASES OVER TIME

50. REGULATORY ISSUES
The US FDA is authorized to prevent transmission of communicable disease. In 2017, regulations defined your personal cells a DRUG because: SVF adipose derived cells are more than minimally manipulated and are not for homologous use. 1. FDA approved trials 2. SVF will have to be evaluated and produced like mass marketed pharmaceutical product severely restricting access to one’s own cells and prohibiting patients with HIV/hepatitis from access entirely 3. Criminalizes physician care of patients 4. Denies patient’s their constitutional rights (14th Amendment) to their own cells.