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OPTIMIZATION OF THE TRANSPLANT SITE

MSCs in the DRI BioHUB Strategy. BIOLOGIC CURE. OPTIMIZATION OF THE TRANSPLANT SITE. TOLERANCE INDUCTION REVERSAL OF AUTOIMMUNITY IMMUNOISOLATION. SOURCE OF INSULIN PRODUCING CELLS. TOLEROGENIC IMMUNOMODULATION. T regs Regulatory T Cells. MSCs. DIPIT. Vitamin D. Low Dose IL-2.

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OPTIMIZATION OF THE TRANSPLANT SITE

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  1. MSCs in the DRI BioHUB Strategy BIOLOGIC CURE OPTIMIZATION OF THE TRANSPLANT SITE TOLERANCE INDUCTION REVERSAL OF AUTOIMMUNITY IMMUNOISOLATION SOURCE OF INSULIN PRODUCING CELLS

  2. TOLEROGENIC IMMUNOMODULATION T regs Regulatory T Cells MSCs DIPIT Vitamin D Low Dose IL-2 Omega 3

  3. Interventional Radiology for Selective Targeting of Pancreatic Arteries for Infusion of MSCs in Subjects with Type 1 Diabetes

  4. MSCs in T1DM (DRI-Stanford/CIRM) Study Design Month 30 Enrollment Month 18 Crossover Month 6 Post T1D Diagnosis MSC 2.5 x 106 cells/kg GROUP 1 (N=20) MSC Assessment CONTROL Assessment GROUP 2 (N=20) CONTROL MSC Assessment Assessment Placebo

  5. Chronic Complications:Chronic Kidney Disease • End stage renal disease (ESRD) remains the major cause of excess morbidity and premature mortality in patients with T1D. • Despite almost universal implementation of renoprotective therapies and attempts to improve glycemic control, the risk of ESDR in T1D is not decreasing but increasing, suggesting that more effective therapies are needed. U.S. Renal Data System (http://www.usrds.org/) Rosolowsky ET et al., J Am SocNephrol2011; Krolewski AS et al., Diabetes Care 2015

  6. The number of new cases of ESRD almost doubled in patients aged 40-49 yrs, suggesting that improved care has not reduced but postponed the onset of ESRD. U.S. Renal Data System (http://www.usrds.org/) Rosolowsky ET et al., J Am SocNephrol2011; Krolewski AS et al., Diabetes Care 2015

  7. Interventional Radiology for Selective Targeting of Renal Arteries for Infusion of MSCs in Subjects with Chronic Renal Disease Overall ↑ in eGFR 2 months after injection. Deterioration between 12 – 18 months for advanced patients. Patients with eGFR >35 at start (all in stage 3A and most in 3B), experienced long-term improvement. Baseline 18 months STAGE 3A STAGE 3B Interlobar artery STAGE 4 STAGE 5 Hilar artery Vascular structural changes within the kidneys 2 months after the injection, reflected by a sustained reduction in the Renal Resistive Index (RRI) at both renal artery (hilar) and interlobar arteries. PRE-PROCEDURE 2 MONTHS POST-INJECTION

  8. Encapsulated Islets-MSC Transplants in a Biologic Resorbable Scaffold on the Omentum

  9. Allotransplantation of Microencapsulated Human Islets in T1D withoutImmunosuppression Azienda Ospedaliera Osp. Niguarda Ca’Granda Milano

  10. DRI FederationProtocol: • Allotransplantation in brittletype 1 diabetesmellitus (Niguarda Hospital, Milan, Italy) • Microencapsulation of human islets (University of Perugia, Italy) • Transplant in omentum (DRI, University of Miami BioHUB Protocol) • Peritransplant treatment with Omega-3 and Vit D (DRI, University of Miami PoseidonProtocol) • Oxygen (DRI, University of Miami Protocol) • Liraglutide treatment of recipients • No immunosuppression

  11. 15%

  12. THE AUTOIMMUNE EPIDEMIC • What role chemicals, heavy metals, viruses, diet, stress, lifestyle and genes play in developing autoimmune disease • How our modern lifestyles and environmental contamination have created a “perfect storm” — the ripest possible conditions for today’s autoimmune epidemic to take hold • The connection between autoimmune disease and allergies, the rates of which are likewise skyrocketing • (https://donnajacksonnakazawa.com/autoimmune-epidemic/) https://www.focusforhealth.org/autoimmune-disease/?gclid=Cj0KCQiA5NPjBRDDARIsAM9X1GLqorlluWtzASWRT7EqbPYk4wGgHFxMI867yewX-3jKX-Sp-BUduBIaAhDQEALw_wcB

  13. Telomere Shortening: Age 0 - 40 INFLAMMATORY DIET 1% 50% 100% Healthy Lifespan Potential ANTI-INFLAMMATORY DIET

  14. Telomere Shortening: Age 40 - 70 INFLAMMATORY DIET 1% 50% 100% Healthy Lifespan Potential ANTI-INFLAMMATORY DIET

  15. AA/EPA Ratio as Healthspan Predictor

  16. The Perfect Nutritional Storm • Increased Omega-6 • Increased Refined Carbohydrates • Decreased Omega-3 • Decreased Polyphenols

  17. MSC and T1DM MSCs, Vitamin D, Omega 3 Shared Tolerogenic Immunomodulation Pathways October 2014 MSCs Vitamin D Omega 3

  18. TOLEROGENIC IMMUNOMODULATION T regs Regulatory T Cells MSCs DIPIT Vitamin D Low Dose IL-2 Omega 3

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