Stem Cell Treatments: Office Based Procedures AAPMR 2015

Transcription

1 Stem Cell Treatments: Office Based Procedures AAPMR 2015 Victor Ibrahim, MD FAAPM&R Regenerative Orthopedics and Sports Medicine Washington D.C.

2 Disclosures No Relevant Financial Disclosures

3 Overview Defining the Landscape Indications For Use Procedure Consideration Pearls for Practice

4 Terminology and Theory

5 Terminology (cont) Adipose Derived Stem Cells (ADSC) Mesenchymal Stem Cells (MSC) Mesenchymal Signaling Cells (MSC)

6 When to Consider Regenerative Medicine? Maximized Rehabilitation Positive Diagnostic Block Limited time off work Surgical Contraindications Mild to Moderate Arthritis New Gold Standard?

7 Relative Contra-indications 1. Cancer: Active? Treated? 2. Infection: Lyme disease 3. Endocrine dysfunction 4. Centralized Pain Syndrome

8 Understanding OA Pathophysiology

9 Disease Associated Molecular Patterns

10 Macrophage Scan Etarfolatide scan Correlation to symptoms and radiographs Kraus V, et al Osteoarthritis Cartilage, 2013:21

11 CD Markers

12 OA: A New Definition

13 Translation: Clinical Evaluation

14 Is the patient optimized? Physiologically Labs/PE Mechanically Therapy/Bracing

15 Labs to Consider Men 1. CBC 2. CMP 3. 8AM Cortisol 4. Total and Free Testosterone 5. TSH, Free T4, Free T3 6. Vitamin D25 OH 7. DHEA-S 8. IGF-1 9. Prolactin 10. PSA For men over AM Fasting Insulin Level 12. Lyme PCR/Titer Women 1. CBC 2. CMP 3. 8AM Cortisol 4. Total and Free Testosterone 5. TSH, Free T4, Free T3 6. Vitamin D25 OH 7. DHEA-S 8. IGF-1 9. Prolactin 10. LH and FSH 11. Post-Menopause: Estradiol/Progesterone 12. 8AM Fasting Insulin Level 13. Lyme PCR/Titer Courtesy of Brian Shiple, D.O.

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17 Sources of Regenerative Material

18 Common Regenerative Methods Prolotherapy Autologous Blood Products Bone Marrow Cells Fat Derived Cells

19 Patient Positioning

20 Preparing Needles/Syringes 1. On sterile field prep two 30mL Heparin Solution (1,000 U/mL) 2. Rinse Jamshidi Needle AND syringes prior to needle insertion 3. Load syringes with 3mL Of Anticoagulant Citrate Dextrose (ACD-A)

21 Jamshidi Needle Aspiration 1. Small incision for needle 2. Insert needle to bone contact 3. Advance between 3-5cm 4. Begin aspiration 4-10 ml 5. Rotate needle 90 degrees, continue to aspirate

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23 Processing Cells mL volume: 10% rule 2. Centrifuge at 3G (3000 RPM for standard system) 2. Approximately 12 minute spin cycle 3. Isolate buffy coat

24 Pearls for BMAC Harvesting 1. Consider sedation 2. Obtain vitals prior to aspiration 3. Steristrip over wound 4. Note harvesting site in medical record 5. Do not retap same site for 6 months

25 Post Procedure Care 1. Monitor site for infection 2. Cautious use of Tylenol 3. No swimming/bathing 24 hours 4. Recommend 4 weeks followup

26 Practical Applications

27 Is More Better? 1. BMAC + PRP 2. BMAC + PRP + HA 3. BMAC + PRP + Glucosamine + HA

28 Prospective, Randomized and Double-Blinded: Avascular Necrosis FICAT: I-III CD + BG WOMAC WOMAC 45 patients CD+BG+BC CD: Core Decompression BG: Bone Graft BC: Bone Marrow Cells 24 mo PAIN Pain Progression of AVN Stem Cell Research & Therapy 2014, 5:115 doi: /scrt505 Published: 14 October 2014

29 Adjunct Therapy 1. Oral Supplements 2. Hyaluronic Acid 3. Prolotherapy (dextrose) 4. Glucosamine Injections 5. Ozone

30 Phase I: Acute Phase Post Procedure Day Precautions Therapy Goals Home Program 1-2 PWB PROM Consider Bracing 2-7 WBAT AROM Closed Chain Program

31 Phase II: Functional Post Procedure Day Precautions Therapy Goals Home Program 7-14 None High Resistance/ Closed Chain Continue Closed Chain Program

32 Phase III: Maintenance Post Procedure Day Precautions Therapy Goals Home Program None Functional Movement Patterns Proprioception Exercises None Open Chain Agility Long term HEP

33 Are Cells Drugs? 1. Autologous use of human tissue is not considered a drug (ie skin grafts, tendon transfers). 2. Manipulated tissue or cells ARE a drug.

34 What does this mean? Cells become a drug when the intervention: alters the MSCs relevant biological characteristics and is therefore more than minimal manipulation. Circuit Court Judge Thomas Griffith DC Circuit of Appeals (2/4/2014)

35 Know Your Landscape Hospital Based Practice Community Practice Regional Norms Local Politics 35

36 Dealing With Cost Consider Prolotherapy Sliding Scale Dealing with Managed Care Worker s Compensation

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38 Thank you!