HSCT

1. HSCT

2. EDSS Ratings Scale

3. HSCT (Hematopoietic Stem Cell Transplant) • MS Meds Issues: • Must be taken for life. • Each has their own set of possible serious side effect. • Compromises the immunity system. • Only delays the progressive phase of the disease. (90% of RRMS evolve into SPMS. Radaelli 2014) • (No [meds] has conclusively shown to significantly alter long-term outcomes. Saccardi 2012) • The reason you have not previously heard of HSCT and it's curative effect on MS is because it is still a rather uncommon procedure for treatment of MS. It is just now starting to gain more traction and acceptance by the broader medical community for the treatment of MS. • Neurologists dismiss/discount HSCT: • Not trained in HSCT - Not familiar with current HSCT results/safety. • Not developed by neurologists - outside of their field. • Not FDA approved (yet Medicare pays for) • Claim it is experimental - Wrong. Performed over 50,000 times every year for cancer. • Financial. • HSCT is currently the ONLY treatment that has been scientifically verified to stop the underlying MS disease process, restore normal immune self-tolerance and produce lasting curative symptomatic improvement for the majority of MS patients.

4. HSCT (Hematopoietic Stem Cell Transplant) • Clinical studies are the foundation of all medical practice. Studies are vetted by publishing in scientific journals where the analysis and conclusions of the study are reviewed by experts in the field to ensure the study is scientifically sound. • HSCT is essentially a one-time chemo treatment, Not a Stem Cell procedure. ( I have yet to find a clinical study demonstrating any long-term benefit from any Stem Cell procedure.) • Can be thought of rebooting the immunity system to a period prior to "contracting" MS. Halts of all underlying disease activity & progression. HSCT, by itself, does NOT reverse any damage already done. • The only role of Stem Cells is to accelerate the restart of your immunity system. • After HSCT 50% of people experience an EDSS improvement. With the attack stopped, your body gets the chance to heal what it can. (Shevchenko 2015, Atkins 2016) • Although likely that the progression of MS disease activity will be stopped in all forms of MS (both relapsing and progressive) following HSCT, people with advanced progressive MS are unlikely to see much overall improvement (reversal) of existing symptoms, if at all. • HSCT was first developed in the 1960s for blood and bone marrow cancers. First for MS done in 1995. Now performed 50,000 times every year. • HSCT procedure has evolved over the years. It is now very safe - safer than driving/riding in a car. • HSCT treatable side-effects: ITP (2%), Hypo/hyperthyroid (6%) (Burt 2015). • HSCT is not FDA approved - yet Medicare (& other insurance) covers HSCT. • I have more than 35 clinical studies (since 2002) demonstrating the benefit of HSCT for MS.

5. Event-Free = No relapse or progression. Source: Long Term Outcomes of HSCT with reduced-intensity conditioning in MS (2015 Shevchenko)

6. Peer Reviewed HSCT Studies

7. Sample of Insurance Providers Covering HSCT Medicaid of Illinois approved 2009 MediCARE Plus Blue approved 2011 United Healthcare approved 2012 Humana Military approved 2013 BCBS FL approved 2016 Blue Shield of Northeastern New York approved 2007 Humana approved 2008 Priority Health approved 2008 Blue Cross & Blue Shield of Illinois approved 2008 Blue Cross & Blue Shield of Kansas City approved 2008 State of Arizona approved 2008 State of California approved 2008 Blue Cross & Blue Shield of North Carolina approved 2008 Aetna approved 2008 Blue Cross & Blue Shield of Illinois approved 2009 Blue Cross & Blue Shield of Kansas approved 2009 Blue Cross & Blue Shield of Illinois approved 2009 Aetna approved 2010 Blue Cross & Blue Shield of Kansas approved 2010 MAXIMUS (thru State of California) overturned Health Net Life Ins Blue Cross Blue Shield California approved 2010 ODS/Moda Health approved 2010 BCBS of GA approved 2010 BCBS of Illinois approved 2011 BCBS of Illinois approved 2011 Managed Medical Review Organization (MMRO) IRO 2011 Federal Blue Cross/Blue Shield approved 2011 United Healthcare Choice Plus-HRA approved 2012 Aetna approved 2012 Wellmark of South Dakota approved 2012 Aetna approved 2012 Cigna approved 2012 BCBS Regence approved 2012 Health Alliance approved 2012 Blue Cross & Blue Shield of North Carolina approved 2012 Optum Health approved 2012 Wellmark of South Dakota approved 2012 BCBS Federal Program approved 2012 CA Anthem Blue Cross - PPO approved 2013 Anthem Blue Cross approved 2013 State of Illinois approved 2013 State of Illinois approved 2013 State of Illinois approved 2013 BCBS Federal Program approved 2013 Care First BCBS approved 2013 Cigna approved 2013 BCBS Regence approved 2013 Anthem BCBS approved 2013 BCBS of Illinois approved 2013 State of Texas overturned BCBS of Texas denial 2013 PHCS United Health Group denial was overturned by independent review 2013 Blue Cross Blue Shield Federal Employee Plan approved 2013 BCBS of Oregon approved 2013 Aetna approved 2013 Blue Cross & Blue Shield of Kansas City approved 2013 Medicare/Medical Mutual of Ohio approved 2013 HealthAlliance (state of Illinois plan) approved 2013 Humana approved 2014 United HealthHumanaHumanacare approved 2014 Tricare Standard North Region (Health Net Federal) approved 2014 Blue Cross & Blue Shield of Alabama approved 2014 Cigna approved 2014 Keystone Health Plan East Blue Cross/Blue Shield of PA approved 2014 Aetna Open Access approved 2014 BCBS Federal Employee Program - Basic approved 2014 United Healthcare approved 2014 BCBS Federal Employee Program - Standard Plan approved 2014 Blue Cross & Blue Shield of Michigan (PPO) thru the ‘Obamacare’ exchange2014 NGS Cofinity (contract with Optum) approved 2014 United Healthcare - PPO approved 2014 Aetna approved 2014 Aetna approved 2014 Cigna approved 2014 Blue Cross & Blue Shield of Michigan approved 2014 Cigna approved 2014 HealthLink (state of Illinois employees) approved 2014 Harvard Pilgrim PPO approved 2014 Cigna approved 2014 SelectHealth approved 2014 Aetna approved 2014 BlueShield of CA - High Option PPO approved 2014 United Healthcare approved 2014 Blue Cross & Blue Shield of Michigan approved 2014 United Healthcare Choice approved 2014 Select Health Care plus approved 2014 Blue Cross & Blue Shield of Michigan approved 2015 Community Care Oklahoma – PPO Select approved 2015 CareFirst Blue ShieldBlue Cross Blue Shield ”Blue Preferred” approved 2015 Aetna Select, Illinois approved 2015 Aetna POS approved 2015 UMR / United Healthcare Choice Plus approved 2015 Community Care PPO Select approved 2015 UHC- CarePlus approved 2015 Anthem BC-BS of OH approved 2015 BCBS of MO approved 2015 BCBS of Illinois approved 2015 (self-insured plan & employer overrode prior denials)

8. HSCT Centers Note: Several centers listed above are accepting very few, if any patients: Seattle, Denver, Ottawa, London

9. HSCT Centers Accepting Progressive MS Russia $40k Mexico $54k Does have a cancellation list EDSS 7.5 max Israel (Two separate clinics) $120k India (Just starting up) Philippines $82k Germany $80k Spain (case-by-case) $88k Accepts only RRMS patients: Chicago Italy Not currently accepting patients: Seattle, Denver

10. HSCT Procedure Timeline • Pre-Testing (Outpatient 1 day) • MRI, CT scans, blood work, pulmonary function tests, etc. • Go home for a week or more. • Mobilization/Harvest Stem Cells (Inpatient 1 day, outpatient 8-9 days) • Mobilize stem cells from bone marrow into blood stream. • Collect and store stem cells. • Go home for a week or more. • Conditioning/Transplant (Inpatient 15-18 days) • 4 days chemo. • Re-infuse collected stem cells. • 10 days to restart immunity system. • Fly home -- commercial airline! • Comments: • Approximately 1 year for immunity system to return 100%. • No further procedures. • No ongoing medication.

11. HSCT Links National Institute of Health (NIH) recognizing value: https://www.nih.gov/news-events/news-releases/stem-cell-transplants-may-induce-long-term-remission-multiple-sclerosis Best Ongoing HSCT information sites: HSCT -MS & Autoimmune Diseases https://www.facebook.com/groups/149103351840242/ Chicago HSCT - Official Patient Run https://www.facebook.com/groups/burthsct/ Excellent HSCT Summary: https://en.wikipedia.org/wiki/Hematopoietic_stem_cell_transplantation Excellent HSCT video by the BBC: http://www.dailymotion.com/video/x3n5jjl_can-you-st0p-my-mutiple-sclerosis-bbc-panorama-14th-dec-2015-720p_school HSCT halts MS progression in 91% of patients http://www.sciencealert.com/years-after-new-stem-cell-treatment-90-of-ms-patients-remain-in-remission Most MS Patients Who Received HSCT Still in Remission Years Later http://www.healthline.com/health-news/ms-patients-who-received-stem-cell-transplants-still-in-remission-010715 Ottawa doctors behindbreakthrough multiple sclerosis study http://www.ottawacitizen.com/health/Ottawa+doctors+behind+breakthrough+multiple+sclerosis+study/8189161/story.html Australian 60 Minutes video: https://www.youtube.com/watch?v=SRtgFdKmfdo Dr Richard Burt (Chicago) HSCT overview and patient testimonials (not MS): https://www.youtube.com/watch?v=n-vo-n5awjk Chicago HSCT Center: https://www.nm.org/conditions-and-care-areas/immunotherapy