1. PARKAVENUE STEMCELL™ JOEL B. SINGER, MD, MBA DAVID A. MAYER, MD,JD
PARK AVENUE STEM CELL TREATMENT CENTER® and CELL SURGICAL NETWORK®

2. PARK AVENUE STEM CELL TREATMENT CENTER®
FORMED 2012
DR JOEL SINGER, PLASTIC SURGEON – 35 YEARS EXPERIENCE
DR DAVID MAYER, GENERAL SURGEON, 30 YEARS EXPERIENCE
PURPOSE:TO STUDY ADIPOSE DERIVED STEM CELLS UNDER IRB APPROVED RESEARCH PROTOCOLS USING CUSTOMIZED EQUIPMENT
AFFILIATE OF AN INTERNATIONAL RESEARCH NETWORK

3. What Is Regenerative Medicine?
Uses stem cells and growth factors
Repair or replace tissue or lost organ function due to damage, or congenital defects
Create living, functional tissues
Stimulate previously irreparable organs to heal themselves

4. What is a Stem Cell? A cell that can proliferate (replicate)
A cell that can differentiate (turn into other specific cells or tissues)

5. TWO TYPES OF STEM CELLS
EMBRYONIC
ADULT MESENCHYMAL

6. Embryonic Stem Cells
Can turn into any type of tissue in the whole body
Moral and/or ethical issues
Derived from human embryos aborted or left over from In Vitro Fertilization
Different DNA from host
Can form tumor cells (teratomas)

7. Adult Mesenchymal Stem Cells
Found all over the body
Bone marrow produces continual flow of “mesenchymal” stem cells
Fat has abundant source of mesenchymal stem cells
Multi-potent
No moral or ethical issue

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

10. What is a Growth Factor? Polypetide (protein) signaling molecules
Aka “cytokines”
Usually 200 amino acids
Messengers that tell cells how to function
Naturally produced by cells or can be admnistered as a drug or even a cosmetic

12. MAIN SOURCES OF ADULT STEM CELLS
Bone marrow (1/20,000 cells)
Fat (aka adipose derived regenerative stem cells)
Others (cord, organs)-low numbers

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

14. ADIPOSE DERIVED STEM CELLS

15. 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.

16. How Do Stem Cells Heal? Dormant if no tissue damage or injury
They respond to tissue injury, inflammation, degeneration, or cell death.
Tissue damage-homing properties
Cells may turn into needed tissue
Cells may provide messaging through Growth Factors (e.g. cytokines) to repair damaged cells.

18. 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

19. Recent Technological Advances
New equipment and enzymes
Adipose (fat) derived stem cells are easy to harvest
Safe – under local anesthesia
Safe – Autologous (your own cells)
Abundant numbers of cells
Procedure takes 3 hours total

20. SVF STROMAL VASCULAR FRACTION
PART OF FAT RICH IN ADULT MESENCHYMAL STEM CELLS AND NATURAL GROWTH FACTORS
WHAT WE DEPLOY AT PARK AVENUE STEM CELL TREATMENT CENTER®

21. Preparing SVF Harvest fat under local anesthesia
Centrifuge to concentrate the fat
Add an enzyme to digest collagen tissue that binds fat cells and stem cells
Remove stem cells (stromal vascular fraction) from bottom of syringe – “closed (sterile) technique”

24. TIME MACHINE™ CENTRIFUGE/FILTRATION SYSTEM
SVF PROCUREMENT TAKES 80 MINUTES

25. CELL IMAGING AND VIABILITY TESTING

26. Magnification x 200
Stem/progenitor cells

27. SVF Deployment methods:
Direct injections into affected arthritic joints
Injection into difficult areas via fluoroscopy
Intravenous injection to affect systemic changes
Injection into spinal fluid or other remote areas
Directly into arteries of body or brain
Directly into soft tissues showing damage

28. WHAT DOES SVF DO? SVF IS REGENERATIVE SVF IS ANTI-INFLAMMATORY
SVF IS IMMUNO-MODULATORY

29. What Can Stem Cells Be Used For?
Orthopedics
Degenerative Diseases
Cardio-Pulmonary Diseases
Autoimmune Diseases
Urology
Neurology
Cosmetic Surgery

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

31. Prior to SVF deployment

32. 4 months after SVF deployment

33. Before and After Comparison
Prior to SVF deployment
4 months after SVF deployment

34. Womac
Western Ontario and
McMaster Universities Arthritis Index

35. CSCTC Assessment Questionnaire
California Stem Cell Assessment Questionnaire
Rated 0-10 (10 being worst)
Left Knee
Right Knee

36. 2 YEAR HIP DATA

37. Cardio-Pulmonary End Stage CHF Ischemic Cardiomyopathy Acute MI
Asthma/Restrictive Lung Disease
COPD/EMPHYSEMA
Not Pulmonary Fibrosis

38. Autoimmune FIBROMYALGIA SCLERODERMA POLYCHONDITIS CIDP
FIBROMYALGIA
SCLERODERMA
POLYCHONDITIS
CIDP
MYASTHENIA GRAVIS
RHEUMATOID ARTHRITIS
CROHNS DISEASE
AUTO-IMMUNE HEPATITIS
RELAPSING POLYCHONDRITIS
ALOPECIA AREATA
OPTIC NEURITIS

39. Urology Interstitial Cystitis Peyronies Disease
Post prostatectomy Incontinence
Erectile Dysfunction

40. INTERSTITIAL CYSTITIS

41. CSCTC ERECTILE DYSFUNCTION
2012 DATA FROM ISRAEL FOR LOW INTENSITY SHOCK WAVE THERAPY ESWT
CONTROLLED MICROTRAUMA STIMULATES STEM CELLS AND NEW BLOOD VESSEL FORMATION
AUTOLOGOUS STEM CELLS CAN BE ADDED
TREATMENT REQUIRES ONE WEEK

42. UROLOGIC LITERATURE
Int J Androl Apr;35(2): Tadalafil once daily and extracorporeal shock wave therapy in the management of patients with Peyronies disease and erectile dysfunction: results form a prospective randomized trial. Palmieri A, Imbimbo C, Creta M, Verze P, Fusco F, Mirone V
Journal of Urology, Vol187(4): Supplement Page e606, April Does low intensity extracorporeal shock wave therapy have physiologic effect on erectile function? Vardi Y, Appel B, Kichevsky, Gruenwald I
Journal of Sexual Medicine 2012 Jan 9(1): Epub 2011 Oct 18 . Low intensity extracorporeal shock wave therapy- a novel effective treatment for erectile dysfunction in severe ED patients who respond poorly to PDE5 inhibitor therapy. Gruenwald I, Appel B, Vardi Y.

43. STORZ D-ACTOR
At CSCTC we are implementing Low Intensity Shock Wave technology using a Storz D-Actor machine which has been specially designed for penile treatment but is NOT specifically FDA approved for peyronies or erectile dysfunction. Therefore, the device is being used “off-label” for this purpose.

44. SHOCK WAVE GENERATOR

45. ACOUSTIC ENERGY WAVES

46. 11 ED PATIENTS AGES 32-73 5 PEYRONIES 3 VENOUS LEAK
Data presented to the American Urologic Association for 2014 meeting

47. ERECTILE FUNCTION SCORE IIEF

48. ERECTILE HARDNESS GRADING SCORE

49. PEYRONIES DATA- 5 PATIENTS

50. PEYRONIES

51. Neurology Parkinson’s Multiple Sclerosis Muscular Dystrophy Neuropathy
Alzheimer’s and Mild Cognitive Impairment
Stroke Recovery and Brain Injury
Partial Spinal Cord Injuries?
ALS
CNS DEPLOYMENT AVAILABLE

52. Opthalmology Retinitis Pigmentosa
Age related- dry type- Macular Degeneration
Lebers disease
Glaucoma

53. Cosmetic Surgery Fortify fat grafts for better survival
Face, breasts, buttocks, hands, etc.
May be able to treat and improve skin quality
May be able to delay aging by adding to existing fat

54. COSMETIC GROWTH FACTORS
AQ PRODUCTS
FDA APPROVED FROM CELLS
HAIR, SKIN, LASHES, VAGINAL LINING

55. Park Avenue Stem Cell Treatment Center is collaborating with Phoenix Stem cell Treatment Center and New England Hair Institute to provide Neograft hair transplantation protocols

56. Hair Restoration protocol
SVF ALONE IS NOT VERY EFFECTIVE
SVF CAN SYNERGIZE WITH NEOGRAFT FOLLICLE TRANSFER TECHNOLOGY TO IMPROVE HEALING AND GRAFT TAKE
AQ GROWTH FACTORS CAN ALSO HELP

57. Other Degenerative Diseases
CRITICAL LIMB ISCHEMIA WOUND CARE TMJ SYNDROME LICHEN SCLEROSIS ANTI-AGEING

58. Adverse Events Over 2000 cases with no serious complication
No documented cases of serious injury in human or animals
International Stem Cell Society (ISCS) – reported over 2,000 registered cases
Less than 2% complications of any kind
No serious adverse events

59. How many treatments are required?
Depends on condition being treated
In we can cryopreserve cells for future use
In 2016 – we can expand cells

60. Who Are Not Candidates?
Active Cancer
Infection

61. USA – FDA Not Regulated If:
Use patients own cells
Provide service during same operative procedure
Minimally manipulate cells
Do not promote therapy or make claims
Performed as a surgical procedure (no laboratory)

62. Evidence of Success:
Need IRB approved (FDA registered) studies to support valid claims
Research meetings
Anecdotal and testimonial information
Early results from clinical trials
Veterinary literature
Personal experience with our own patients in USA (more than 1000)

63. Stem Cell Research Today
UNIVERSITY/PHARMA LABS
FDA APPROVED TRIALS
MOSTLY BONE MARROW AND SOME EMBRYONIC
LONG TIME FOR OUTCOMES
PATENT ISSUES
FOR INSTITUTIONAL PROFIT/GOVT FUNDED
DRUG MODEL
GRASSROOTS /COMMUNITY
PHYSICIAN’S PRACTICE
BONE MARROW AND ADIPOSE DERIVED
RAPID CLINICAL EVALUATION
WIDESPREAD AVAILABILITY
NO PATENTS NEEDED
FOR PROFIT/PATIENT FUNDED
NOT “DRUG ORIENTED”

64. CSN CELL SURGICAL NETWORK™ In Association with the
Park Avenue Stem Cell Treatment Center
CSN

65. CELL SURGICAL NETWORK MISSION
International research sharing protocols and database including Asia and Canada
High numbers of fresh autologous cells for various degenerative conditions
Standardized Multispecialty care, techniques, and equipment
Advanced deployment methods
Quality Stem Cell Therapy should be available everywhere and easily accessible

66. EDUCATIONAL WEBSITE