VRM copyright Vet-Stem, Inc.

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Barbara Wilkinson
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Cell Selection: Science and Legality Credentialing Course Veterinary Regenerative Medicine 103

þ What type of stem cell should I use? þ Cells, PRP, or Both?

þ Liability Central Laboratory versus in-house kit?

inten1on to change the cells (i.e. ac1va1on) FDA Approval Required if (none currently approved):

1 Cell Selection: Science and Legality Credentialing Course Veterinary Regenerative Medicine 103 Slide 1 Choosing Your Cells - Outline þ What is legal currently? þ What type of stem cell should I use? þ Cells, PRP, or Both? þ What quality control measures are important? þ Liability Central Laboratory versus in-house kit? Slide 2 FDA Legal Issues Allowed: - autologous use - no addi1ves or pre- diﬀeren1a1on - no inten1on to change the cells (i.e. ac1va1on) FDA Approval Required if (none currently approved): - allogeneic or donor cell usage - any diﬀeren1ated or changed cell type - embryonic or induced Pluripotent Cells Boxer, L. FDA Center for Veterinary Medicine. 2nd North American Veterinary Regenera5ve Medicine Mee5ng, 2011 Slide 3 VRM copyright, Inc. 1

2 Two Major Choices in Adult Stem Cells Parameter Adipose Bone Marrow Harvesting Easy, Low morbidity Difficult, Moderate pain Cell Yields 43% 0.02% Time collect to treat 1-2 days Weeks Cell culture required No Yes Vidal et al, Vet Surg, 2006 & Vidal et al, Stem Cells Dev 2012 Zhu et al. Adipose- derived stem cell A beper stem cell than BMSC. Cell Biochem Func 2008;26: Slide 4 Why Adipose Tissue? A search of PubMed using the terms adipose and stem cell yields over 2000 peer-reviewed articles, making the ASC one of the most popular adult stem cells currently being explored today. Zuk, PA, Mol Biol Cell Apr 7. The Adipose-derived Stem Cell: Looking Back and Looking Ahead.(Univ California) Slide 5 Scientific Evidence Adipose vs Marrow v Richest source 1,2,4,5 v Low morbidity for collec1on 1,4,5 v Beyond Stem Cells heterogenous 1,4,5,7 v Immediate Use prevent degenera1on/scar 1,4,5 v Younger Cell rapid and extended growth 3,4 v Lower adverse events reports 8,9 v Improved clinical outcomes 8,9 1. Zuk, PA, Mol Biol Cell The Adipose- derived Stem Cell: Looking Back and Looking Ahead. 2. Vidal et al, Vet Surg, 2006 & Vidal et al, Stem Cells Dev Zhu et al. Adipose- derived stem cell A beper stem cell than BMSC. Cell Biochem Func 2008;26: Tapp et al. Adipose- Derived Stem Cells: Characteriza1on and Current Applica1on in Orthopaedic Tissue Repair. Exp Biol Med Chung, Hayashi (UCD), Res Vet Sci, Varma et al, Stem Cells and Development 2007: Ferris et al, Proc AAEP, Harman et al, Proc 1 st NAVRMA, 2010 Slide 6 VRM copyright, Inc. 2

3 Adipose versus Marrow Stem Cells Frequency Bone Marrow* (1 in 4,224 cells) 0.02% Fat * (1 in 2.3 cells) 43% Doubling Times Bone Marrow * 4.9 +/- 1.6 days Fat * 2.1 +/- 0.9 Doublings to Senescence Bone Marrow + 32 Fat + 80 * Same horses - Vidal et al, Vet Surg, 2006 & Vidal et al, Stem Cells Dev 2012 Slide 7 Adipose and Bone Marrow Case Series Tendon/Ligament - Equine VOS st NAVRM 2010 AAEP 2009 Slide 8 Safety Equine By Cell Source Adipose SVF 0.6% (n=27/4,825, intraarticular and soft tissue) Adipose Cultured 0.5% (n=1/193) Harman et al, Proc 1 st NAVRMA, 2010 Bone Marrow Cultured 8.0% intraarticular 1.7% ligament Ferris, Frisbie et al, Proc AAEP, 2009 Embryonic Stem Cells 10% immediate inflammatory reaction Quite painful Snow, Proc 1 st NAVRM, 2010 Slide 9 VRM copyright, Inc. 3

Through 6/30/12 Slide 10 Quality Control Systems Sterility Validated procedures Certified trained technicians Calibrated equipment Quality

4 Safety Profile Canine ASC 5 of 5,916 (0.1%) injections showed an adverse event possibly or probably related to stem cell injection. None were systemic. All were local joint inflammation. data. Through 6/30/12 Slide 10 Quality Control Systems Sterility Validated procedures Certified trained technicians Calibrated equipment Quality Assurance Inspections Dose Control cell count/viability Slide 11 Sterility 1. Tissue handling - HOOD 2. Cell separations 3. Equipment cleaning 4. Syringe filling 5. Routine sterility checks Slide 12 VRM copyright, Inc. 4

Slide 13 Cell Counting is the Most Critical Step You cannot do in the clinic without special, expensive equipment (not hematology

5 Sterility Ø 25% of all samples collected in an aseptic surgery are contaminated with bacteria. Ø Critical that the processing steps assure the final cell product is properly processed and cleaned. Slide 13 Cell Counting is the Most Critical Step You cannot do in the clinic without special, expensive equipment (not hematology analyzer). Morrison D et al. Stem cell coun1ng methods can lead to inaccurate dosing. Bioprocessing J, Slide 14 Drug?? mg/ml Stem Cells?? Cells/ ml Slide 15 VRM copyright, Inc. 5

Dose Control cell count/viability/banking 1. Automated standard cell counts multiple doses 2. Assessment of viability 3. Safety Validation sterility/endotoxin/enzyme 4.

6 Dose Control cell count/viability/banking 1. Automated standard cell counts multiple doses 2. Assessment of viability 3. Safety Validation sterility/endotoxin/enzyme 4. Adjustment of volume/doses to injury need 5. Cell banking for future doses Slide 16 Who is Liable for the Quality? Task Liability Processing sterility Removal of enzymes Cell counting Dose calculation Sterile syringe filling Banking calculations In- Kits Slide 17 Do stem cells need activation? - FDA says you cannot change cells - In vivo use of hmscs for therapeutic indications does not require priming Singer and Caplan, Ann Rev Pathol Mech Dis 2011; 6: Slide 18 VRM copyright, Inc. 6

7 Summary of Cell Choices 1. FDA has jurisdiction over stem cells and autologous (no donor cells) is allowed but you can t change the cells. 2. Adipose is the most prominent stem cell type in veterinary medicine and has distinct advantages. 3. Quality control is paramount in veterinary regenerative medicine and central lab control provides the most consistent quality and reduces your clinic s risk and labor. Slide 19 VRM copyright, Inc. 7

Dr Peter Chapman-Smith. Dr Steve Peloquin Pain Medicine/Anesthesiology USA

Dr Peter Chapman-Smith. Dr Steve Peloquin Pain Medicine/Anesthesiology USA Dr Steve Peloquin Pain Medicine/Anesthesiology USA Dr Peter Chapman-Smith Phlebologist and Appearance Medicine Physician Whangarei 14:00-14:55 WS #53: The Impact of Stem Cell Therapy For Your Patients