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Human Embryonic Stem Cell therapy in Children with Cerbral Palsy

Dr. Geeta Shroff, Founder and Medical Director of Nutech Mediworld, offers stem cell therapy for various disorders including cerebral palsy, spinal cord injury, diabetes, genetic disorders, musculoskeletal disorders, and more. The therapy utilizes in-house cultured human embryonic stem cells, free of animal products and contaminants, with no significant adverse events reported in over 13 years of therapeutic usage.

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Human Embryonic Stem Cell therapy in Children with Cerbral Palsy

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  1. Human Embryonic Stem Cell therapy in Children with Cerbral Palsy Dr. Geeta Shroff Founder and Medical Director, Nutech Mediworld

  2. Cell Culture Technology Spinal Cord Injury Diabetes Type 1 & 2 Auto-immune Disorders Genetic Disorders Musculo-skeltal Disorders Skin Conditions Treated Bed Sores hESC Therapy Burns Wounds Cardiac , & liver Disorders Vision Neurological disorders

  3. Conventional derivation Sperm Egg Trophoblast Blastocoele Throw-away fertilized ovum Inner Cell Mass (Embryoblast) In-Vitro Fertilization Blastocyst Isolated Cells Pluripotent Other Products Fetal Bovine Serum Research Only (Animal Protein Contamination) Disadvantages Antigen-antibody reactions Immunosupressants required Teratomas formed Chromosomal instability Mouse Feeder Cells Cells cultured in Lab

  4. HESC: We Culture Them Differently Day 0 1 2 3 4 5 6 2- Cell 4 Cell 8- Cell 16- Cell 32- Cell 64- Cell 128- Cell Neuronal cell Re-incubated Stored Re-incubated Incubated Stored No Feeder Layer No Animal Product Ready to use Cell Cultures Non-neuronal cell Ready to use Cell Cultures

  5. Technology Highlights • Patented technology1,2 • In-house cultured hESC from a Single Fertilized Ovum • Non- contaminated • Free of animal products stable cell lines upon 4000 passages3 • Viable and ready-to-use product form • Simple, Cost-effective and Scalable • No immunosuppressants needed • No significant adverse event in over 13 years of therapeutic usage 1. http://patentscope.wipo.int/search/en/WO2007141657 2. Shroff G, International Journal of Recent Scientific Research 3. Paper communicated

  6. Our history 1999 -2000 2000-02 2005 2006 2012 2013 2009-2015 *Shroff G et al. Annals of Neurosciences. 2015;22(3).

  7. CEREBRAL PALSY IN CHILDREN • Prevalence of CP around the world ranges from 1.5 to more than 4 per 1,000 live births1 • Caused by permanent, non-progressive brain lesion 1 http://www.cdc.gov/ncbddd/cp/data.html

  8. SYMPTOMS Stiff or floppy posture , Excessive lethargy or irritability/ High pitched cry, behavioral issues Weak suck/ tongue thrust/ feeding difficulties, speech difficulties, visual problems Poor head control, hypertonia or hypotonia

  9. Cerebral palsy: The Disease • Motor, Cognitive and/or Motor-Congnitive Disorder • 35% -50% of children with CP also have seizure disorder and some level of mental retardation • May have learning disabilities and vision, speech, hearing, or language problems

  10. Available Conventional Treatments • Medicines Botox, IntrathecalBaclofen- control muscle spasms and seizures, Glycopyrrolate -control drooling Pamidronate -may help with osteoporosis • Surgery may help To relieve muscle tightness Straightening of different twists or unusual curvatures of leg muscles Improve the ability to sit, stand, and walk No treatment can cure it 100%

  11. STUDY DESIGN PATIENTS 101 Patients suffering from CP were included AGE GROUPS <2yrs, 2-4yrs, 4-6yrs, 6-12 & 12-18 yrs. TREATMENT Study divided in four treatment phases. T1, T2, T3 & T4 PARAMETERS SPECT SCANS GMFCS NFS SCORE ADVERSE EVENTS Safety evaluation was done by measuring adverse events in all treatment phases

  12. TREATMENT PLAN FOR 101 CP PATIENTS 0.5ml IM once daily followed by 1.0 ml IV twice every 7 days* T1 (N=91, 8 Weeks) T2 (N= 66, 4 Weeks) After 3-6 months gap of T1 0.5ml IM once daily followed by 1.0 ml IV twice daily every 7 days* Test dose (0.05 ml sc on forearm) to check hypersensitivity T3 (N= 38, 4 Weeks) After 3-6 months gap of T2 0.5ml IM once daily followed by 1.0 ml IV twice daily every 7 days T4 (N=15, 1 Month) After 12 months gap of T3 Same+ Additional 1ml IV dose *Caudal route if required, or deep muscle spinal cord injection 1 ml weekly in T1 & T2

  13. Study Characteristics • Most patients were males (71.4%) aged up to 18 yr • Total treatment days were: • T1 - 60 days • T2 - 30 days • T3 - 33 days • T4 - 29 days • Data for all the patients was validated by Moody International and Quality Austria Central Asia Pvt Ltd.

  14. Gmfcs –international scoring system • Provides description of the child’s motor function • Gives an idea of what support the child might need • Is classified according to age • The scores are from 1 to 5 with 5 being the worst.

  15. Majority of Patients Showed Improvement after the Therapy* *Shroff G et al. J Transl Med. 2014;12(1):318

  16. At end of T1, Majority of patients had an improvement by at least one grade in GMFCS

  17. BEFORE TREATMENT SPECT scan of a cerebral palsy patient (grey - normal; red, pink and white - above normal; green, light/dark blue, black -hypoperfused)

  18. AFTER TREATMENT (8 mnths) SPECT scan of a cerebral palsy patient (grey - normal; red, pink and white - above normal; green, light/dark blue, black -hypoperfused)

  19. Nutech Functional Scores (NFS) • A 32 point positional and directional scoring system to evaluate patient with CP* • Each symptom is categorized into 5 ordinal grades (1, 2, 3, 4, 5) in BAD → GOOD direction • Can assess abilities related to sensory system such as feeling and controlling bladder and bowel excretion, hearing, and seeing and cognitive abilities like feeling hotness or coldness and understanding a “command” • Assessed speech and epilepsy outcomes also based on NFS *Shroff et al. International Archives of Medicine. 2015; 8: 117

  20. NFS for Epilepsy Of 101 CP Patients, 59 had Epilepsy

  21. After therapy none of the patients had Epileptic attacks multiple times a day Out of 101, 59 patients were affected for epilepsy

  22. NFS for Speech Of 101 CP Patients, 93 had Speech Problems

  23. Of 93 Affected Patients, 27 had normal Speech at the End of Therapy None of the patient was Non-verbal after the hESC Therapy Out of 101, 93 patients were affected for speech

  24. CORTICAL VISUAL IMPAIRMENT (CVI) • Visual loss due to disturbance in the posterior visual pathway or the visual cortex • Common in patients with CP • No medications or surgical therapies available except rehabilitation therapy

  25. MEASUREMENT OF CVI USING NFS The level of visual impairment was assessed using NFS: Of 101 CP Patients, 40 had CVI

  26. After therapy, 97.5% of patients showed an improvement in nfs by at least one level

  27. BEFORE

  28. AFTER

  29. REPORT

  30. BEFORE AFTER

  31. 69% of the patients showed an improvement in cognitive skills

  32. The AEs were mild and resolved without sequel NO TERATOMA OR IMMUNE REACTION WERE OBSERVED NO IMMUNOSUPPRESSANTS WERE GIVEN TO PATIENTS N= Total number of patients in treatment phase n= No of patients affected with ADEs

  33. CONCLUSION • The size of the hESCs used in our study is less than 1 µm facilitating them to cross the blood brain barrier • The changes in SPECT scan depict that these cells migrated to the affected area and showed an improvement in perfusion • GMFCS scores show that the therapy has improved the overall well being of the patients. Most patients affected with CP were able to improve their quality of life

  34. CONTD… • hESC therapy provided to 101 patients of CP has benefitted patients by reducing their symptoms of epilepsy and improving their speech. • At the end of T1, out of 59 patients affected with epilepsy, 18 patients had shown complete disappearance of epileptic episodes and out of 93 patients whose speech was affected , 48 patients became completely normal. • 18 patients had stopped their anti epileptic medications • Almost all the children (39 of 40) showed improvement in vision by at least one grade. Of the 8 blind patients, all showed improvement in vision (greater than 2). More than half of the patients regained normal vision at the end of the study after receiving hESC therapy

  35. Publications • Shroff G, Das L. Human Embryonic Stem Cell Therapy in Cerebral Palsy Children with Cortical Visual Impairment: A Case Series of 40 Patients. J Cell SciTher. 2014;5(6):1. • Shroff G. A novel approach of human embryonic stem cells therapy in treatment of Friedrich’s Ataxia. Int J Case Rep Images. 2015;6:261–266. • Shroff G, Gupta R. Human Embryonic Stem Cells in the Treatment of Patients with Spinal Cord Injury. Annals of Neurosciences. 2015;22(4). • Shroff, G. Das, L. Use of Human Embryonic Stem Cells (hESCs) in the Treatment of Glaucoma. International Journal of Medical and Pharmaceutical Case Reports. 2015; 4(3):2394-109X. • Shroff G, Barthakur JK. Safety and Efficacy of Human Embryonic Stem Cells for the Treatment of Cerebrovascular Accident: A Case Series. Global Journal of Medical Research. 2015. In Press. • Shroff G. Treatment of Lyme Disease with Human Embryonic Stem Cells: A Case Series. J Neuroinfect Dis. 2015; 6:167. • Shroff G. Human Embryonic Stem Cells in the Treatment of Spinocerebellar Ataxia: A Case Series. J. Clin. Case. Rep. 2015; 5:1. • Shroff G (2015) Human Embryonic Stem Cells in the Treatment of Patients with Duchenne Muscular Dystrophy. J Neurol Res, 5, 186.

  36. Contd… 9. Shroff G, Gupta A, Barthakur J. Therapeutic potential of human embryonic stem cell transplantation in patients with cerebral palsy. J Transl Med. 2014;12(1):318. • Shroff G. Role of Anesthetists in Human Embryonic Stem Cells Transplantation in Patients with Spinal Cord Injury. In Press • Shroff G, Barthakur JK. Safety of Human Embryonic Stem Cells in Patients with Terminal Conditions. Annals of Neurosciences. 2015;22(3). • Shroff G, Barthakur JK, Mohan P, Mahajan H. Single Photon Emission Computed Tomography Scan as a Diagnostic Tool in Children with Cerebral Palsy Treated with Human Embryonic Stem Cells. Journal of Nuclear Medicine and Therapy. 6 (3), 1. • Nutech Functional Score (NFS), a New Scoring System to Assess the Level of Impairment in Patients with Cerebral Palsy. International Archives of Medicine. 2015; 8: 117 • Shroff G. Establishment and Characterization of a Neuronal Cell line derived from a 2-cell Stage Human Embryo: Clinically Tested Cell-based Therapy for Neurological Disorders. International Journal of Recent Scientific Research 2015;6(4):3730-8. • Shroff G, Gupta R, Makhija LK. Evaluation of Wound Healing Ability with Human Embryonic Stem Cells in Patients with Non-Healing Wounds: A Case Series. Journal of Pigmentary Disorders 2015; 2:7.

  37. CONTD….. • Shroff G. Clinical Effect of Human Embryonic Stem Cells Therapy in Two Cases of Cerebral Palsy. J Neurol Res. 2015;5(3):230-232 • Shroff G. Use of Human Embryonic Stem Cells in the Treatment of Age-Related Macular Degeneration. J Clin Exp Ophthalmol 2015; 6:446.  • Shroff G, Barthakur JK, Mohan P, Mahajan H. Single Photon Emission Computed Tomography Scan as a Diagnostic Tool in Children with Cerebral Palsy Treated with Human Embryonic Stem Cells. J Nucl Med Radiat Ther 2015, 6:3. • Shroff G. Human embryonic stem cells (hESCs) in the treatment of emphysematous COPD: a case report. Clinical Case Reports 2015, 3(7): 632-634. • Shroff G. Human Embryonic Stem Cell for the Treatment of Multiple Sclerosis. Case report international. 2015. In Press • Barthakur IK, Shroff G. Natural Selection of Gender of the Baby at Conception: Proposing a Scientific Hypothesis. Science Journal of Public Health 2015; 664-668 • Shroff G. Nutech Functional Score (NFS), a New Scoring System to Assess the Level of Impairment in Patients with Cerebral Palsy. International Archives of Medicine. 2015; 8. • Shroff G, Agarwal P, Mishra A, Sonowal N. Human Embryonic Stem Cells in Treatment of Spinal Cord Injury: A Prospective Study

  38. OUR MISSION TO SEE HUMAN EMBRYONIC STEM CELLS AVAILABLE GLOBALLY AS THE FIRST LINE OF TREATMENT FOR MANY OF MANKIND’S WORST AFFLICTIONS

  39. THANK YOU

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