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Evidence-based Regenerative Medicine Vet-Stem Credentialing Course

Evidence-based Regenerative Medicine Vet-Stem Credentialing Course Veterinary Regenerative Medicine 102. Evidence-Based Medicine - Outline. Regenerative medicine – the new paradigm In vitro evidence of efficacy Laboratory animal studies Canine / Feline / Equine Clinical Data.

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Evidence-based Regenerative Medicine Vet-Stem Credentialing Course

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  1. Evidence-based Regenerative Medicine Vet-Stem Credentialing Course Veterinary Regenerative Medicine 102

  2. Evidence-Based Medicine - Outline • Regenerative medicine – the new paradigm • In vitro evidence of efficacy • Laboratory animal studies • Canine / Feline / Equine Clinical Data

  3. Regenerative MedicineThe New Paradigm

  4. Evidence Based Medicine “The fundamental tenet of EBM is that the practice of medicine should be based on valid, clinically relevant research data, whenever possible” Evidence-Based Veterinary Medical Association, 2012

  5. Evidence Pyramids www.hsl.virginia.edu/collections/ebm/pyramid.cfm

  6. Evidence-Based Medicine www.ebvma.org, 2012

  7. Evidence Based Medicine U.S. Preventative Services Task Force Level I: at least one randomized controlled trial Level IIa: controlled trials without randomization Level IIb: cohort or case-control studies Level IIc: uncontrolled trials – multiple time points Level III: expert opinions U.S. Preventive Services Task Force (August 1989). Guide to clinical preventive services: report of the U.S. Preventive Services Task Force. DIANE Publishing. pp. 24–. ISBN 978-1-56806-297-6.

  8. EBM for Clinical Solutions

  9. Regeneration Via Differentiation AdipogenicOsteogenicChondrogenic Vieira N, Brandalise V, Secco M, et al. Isolation, characterization and differentiation potential of canine adipose-derived stem cells. Cell Transpl 2010;19(3)279-289.

  10. Regeneration Via Differentiation Clinical Relevance: “Equine AT-MSCs represent a suitable cellular source for regenerative treatment of bone or cartilage defects.” Braun et al, Am J Vet Res, Oct 2010, 71(10):1228-1236

  11. Joint Lubrication Lee et al, BiochemBiophys Res Comm, 2008, 376:148-153.

  12. Canine Medial Shoulder Instability Repair • a. Glenoid • b. Glenohumeral lig. • c. Subscapularis ten. • d. Humeral head Sherman Canapp, DVM, Dipl. ACVS; Presented AVMA 2009 Pre – Stem Cell 90 Days Post – Stem Cell

  13. Canine ElbowCoronoid DiseaseCartilage Regeneration Arthroscopy TimelineInitial – surgical cleanup onlyDay 90 – no change, lame, Add adipose stem cell Rx Day 180 – cartilage regeneration Sherman Canapp, DVM, Dipl. ACVS; Presented AVMA 2009 Pre – Stem Cell – Day 90 Day 180 (90 Days Post – Stem Cell)

  14. Rabbit Cartilage Regeneration At 8 weeks, 12/12 (100%) of defects in treated group healing with hyaline-like cartilage. Only 1/12 (8%) of controls healed. Dragoo J et al, “Healing full-thickness cartilage defects using adipose-derived stem cells”Tiss Eng 2007;13(7):1615-21. (Stanford)

  15. Cruciate Ligament -ChondroProtection Sham Surgery Adipose Stem Cell IA Untreated Control Above toluidine blue staining of cartilage surface at 20 weeks after cranial cruciate ligament transection. Only treatment was group B given 1ml of adipose-stem cells by intraarticular injection with no carrier/scaffold. Toghraie et al, “Treatment of osteoarthritis with infrapatellar fat pad derived mesenchymal stem cells in rabbit”The Knee 2011;1:71-75.

  16. Severe Muscle Tears “Adipose derived stem cell therapy demonstrated promising results in five cases of muscle injury in working German shepherd dogs (semitendinosus). All dogs were able to return to their previous training and occupations as police and Schutzhund dogs with a functional gait. In contrast, the surgeon’s previous experience was that the dog’s careers were typically shortened due to apparent fibrosis/muscle contracture, and continuing muscle disease.” Brown SG. Stem Cells Disc 2012;2(2):41-44. 16

  17. Severe Muscle Tear – 5 Cases Scores- 0=Normal, 4=Very Severely Affected Cris: Pre-treatment 84 Days Post-ASC treatment Brown SG. Stem Cells Disc 2012;2(2):41-44.

  18. NA Vet Regenerative Medicine Meeting Marty Gardner, DVM 116 cases proximal suspdesmitis Adipose SVF – ultrasounded guided >90% return to full work, approx 6 months Wes Sutter, DVM, dACVSFlexor tendonitis PRP+ Fresh BM or PRP + Adipose SVF Both better than PRP alone – Early better Chris Johnson, DVM, dACVSFresh BM or Fresh adipose SVF Do not wait 30 days – too much scar Most cases improve over conservative Larry Galuppo, DVM – UCD DDF Lesions - 40 horses – minimum 6 month BMAC, BM cultured, Adipose SVF “Reasonable” success for all treatments Adipose SVF better for severe lesions Scores- 0=Normal, 4=Very Severely Affected 1st North American Veterinary Regenerative Medicine Meeting, 2010

  19. Sport Horse Study Sport Horse Suspensory Study • 84 horses with SL desmitistx with ASCs • All horses tx at single referral center • All dx with diagnostic anesthesia, u/s and/or MRI • Consistent rehab protocol • Stringent outcome measure - in full work for minimum of 1 year Rich, R and Carpenter, E, Outcome of 84 horses with suspensory injuries treated with adipose-derived regenerative cells, Proceedings, NAVRMA, 2012, Savannah, GA

  20. Sport Horse Study 85.7% returned to prior level or higher 13.1% returned to lower level 1.2% did not return to work Rich, R and Carpenter, E. Outcome of 84 horses with suspensory injuries treated with adipose-derived regenerative cells, Proceedings, NAVRMA, 2012, Savannah, GA

  21. 365 Day Pilot Study, 9 dogs Chronic Post-Surgical OA (>3 Mo) Single Surgeon all cases Intra-articular stem cells – 1X Vet and Owner assessments at pre, 30, 90, 180, 365 N=9 for 180 day data Chronic Stifle Osteoarthritis Study

  22. Chronic Stifle Osteoarthritis Study Vet and owner total scores statistically improved at 30 and 90 days over baselines (P<0.001)

  23. Prospective Elbow OA Trial

  24. Prospective Elbow OA Trial

  25. Randomized Controlled Trial

  26. Blinded Hip OA Trial Design 18 DOGS-4 Clinics A: TREATMENT B: CONTROL BASELINE VETERINARY/OWNER EVALUATIONS FAT COLLECTION BOTH GROUPS IA SVF INJECTIONS IA SALINE INJECTIONS VETERINARY AND OWNER EVALUATIONS 30, 60, 90 DAYS Black et al. Veterinary Therapeutics Vol.8, No. 4, Winter 2007

  27. Study Parameters Evaluated Black et al. Veterinary Therapeutics Vol.8, No. 4, Winter 2007 VETERINARY • Lameness walk and trot • Pain on manipulation • Range of motion • Functional disability (stiffness) STATISTICAL - Two-way repeated measures ANOVA - 0.05 level of significance - Two-way RM-ANOVA - Data was pooled for further analysis

  28. Bilateral Coxofemoral OA Study

  29. Spontaneous OA Model with HA PBS HA PBS + MSC HA + MSC Take Home: Use HA with stem cells to improve cartilage repair Lower score = reduce evidence of OA Sato et al. Arthritis Res Therapy. 2012;14:R31.

  30. Randomized Controlled Trial Design: • 8 Horses – 4 treated / 4 controls • Collagenase induced injury – Rx 10 days later • Fully blinded histology • Controls were treated with same volume of saline • Nixon et al. Am J Vet Res, 2008

  31. Cornell/Nixon Tendon Study Saline Control Stem Cell Treated H&E StainPolarized Light -reduce infiltrate (P<0.015) -Imp collagen fiber uniformity (P<0.040 -Imp overall healing score (P<0.028).

  32. Cornell/Nixon Tendon Study SalineControlStem CellTreated

  33. Prospective Tendon Trial . Leppanen et al, Regenerative Medicine, November 4(6), Suppl. 2 (2009), World Conference of Regenerative Medicine, Leipzig, Germany 28-30.10.2009, Proceedings S21.

  34. Summary - Regenerative Medicine 1. In-vitro and laboratory animal data support the mechanisms and the theory of using stem cells in orthopedics. 2. There are uncontrolled and also blinded placebo-control clinical trials that support the validity of use of adipose stem cells in canine and equine medicine. 3. The evidence rises to Level I in support of clinical use in the horse and the dog.

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