INSTITUTIONAL ETHICS COMMITTEE MADRAS MEDICAL COLLEGE, CHENNAI 3 Telephone No : Fax : CERTIFICATE OF APPROVAL
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1 INSTITUTIONAL ETHICS COMMITTEE MADRAS MEDICAL COLLEGE, CHENNAI 3 Telephone No : Fax : CERTIFICATE OF APPROVAL To, Date: 16/12/11 Dr. T. Vidyasagaran H.O.D. Dept. of Vascular Surgery Madras Medical College, Chennai Tamilnadu Study Title: A non-randomized, open label, multi-centric, dose ranging, phase II study assessing the efficacy and safety of intramuscular administration of Stempeucel - CLI (ex vivo cultured adult bone marrow derived allogeneic mesenchymal stem cells) in patients with critical limb ischemia due to Buerger s disease. Study No.: SRPL/CLI/10-11/001 Subject: Approval of the study related document for the use in the above mentioned protocol. Dear Dr. Vidyasagaran, The Institutional Ethics Commettee received, reviewed and discussed the above mentioned study related documents on 23/11/11. The list of the documents which have been reviewed and approved is as follows. 1. Protocol Version 3.0 dated 12 Jul 2. Efficacy Manual dated 12 Jul 3. Investigator s Brochure Edition 6.0 dated 30 Apr English Informed Consent Document Version 3.0 dated 12 Jul 5. ICF Version 3.0 dated 12 Jul, Translated from English to Hindi on 02 Aug 6. ICF Version 3.0 dated 12 Jul, Translated from English to Kannada on 02 Aug 7. ICF Version 3.0 dated 12 Jul, Translated from English to Tamil on 04 Aug 8. ICF Version 3.0 dated 12 Jul, Translated from English to Telugu on 02 Aug 9. ICF Version 3.0 dated 12 Jul, Translated from English to Malayalam on 02 Aug 10. ICF Version 3.0 dated 12 Jul, Translated from English to Urdu on 02 Aug 11. ICF - Hindi Translation Certificate dated 02 Aug
2 12. ICF - Kannada Translation Certificate dated 02 Aug 13. ICF - Tamil Translation Certificate dated 04 Aug 14. ICF - Telugu Translation Certificate dated 02 Aug 15. ICF - Malayalam Translation Certificate dated 02 Aug 16. ICF - Urdu Translation Certificate dated 02 Aug 17. ICF Version 3.0 dated 12 July ; Back Translation from Hindi to English on 16 Aug 18. ICF Version 3.0 dated 12 July ; Back Translation from Kannada to English on 16 Aug 19. ICF Version 3.0 dated 12 July ; Back Translation from Tamil to English on 16 Aug 20. ICF Version 3.0 dated 12 July ; Back Translation from Telugu to English on 16 Aug 21. ICF Version 3.0 dated 12 July ; Back Translation from Malayalam to English on 16 Aug 22. ICF Version 3.0 dated 12 July ; Back Translation from Urdu to English on 16 Aug 23. ICF - Hindi Back Translation Certificate dated 16 Aug 24. ICF - Kannada Back Translation Certificate dated 16 Aug 25. ICF - Tamil Back Translation Certificate dated 16 Aug 26. ICF - Telugu Back Translation Certificate dated 16 Aug 27. ICF - Malayalam Back Translation Certificate dated 16 Aug 28. ICF - Urdu Back Translation Certificate dated 16 Aug 29. The King s College VascuQOL questionnaire dated 12 Jul 30. The King s College VascuQOL questionnaire dated 12 Jul, Translated from English to Hindi on 02 Aug 31. The King s College VascuQOL questionnaire dated 12 Jul, Translated from English to Kannada on 02 Aug 32. The King s College VascuQOL questionnaire dated 12 Jul, Translated from English to Tamil on 02 Aug
3 33. The King s College VascuQOL questionnaire dated 12 Jul, Translated from English to Telugu on 02 Aug 34. The King s College VascuQOL questionnaire dated 12 Jul, Translated from English to Malayalam on 02 Aug 35. The King s College VascuQOL questionnaire dated 12 Jul, Translated from English to Urdu on 02 Aug 36. The King s College VascuQOL questionnaire - Hindi Translation Certificate dated 02 Aug 37. The King s College VascuQOL questionnaire - Kannada Translation Certificate dated 02 Aug 38. The King s College VascuQOL questionnaire - Tamil Translation Certificate dated 02 Aug 39. The King s College VascuQOL questionnaire - Telugu Translation Certificate dated 02 Aug 40. The King s College VascuQOL questionnaire - Malayalam Translation Certificate dated 02 Aug 41. The King s College VascuQOL questionnaire - Urdu Translation Certificate dated 02 Aug 42. The King s College VascuQOL questionnaire dated 12 July ; Back Translated from Hindi to English on 10 Aug 43. The King s College VascuQOL questionnaire dated 12 July ; Back Translated from Kannada to English on 10 Aug 44. The King s College VascuQOL questionnaire dated 12 July ; Back Translated from Tamil to English on 10 Aug 45. The King s College VascuQOL questionnaire dated 12 July ; Back Translated from Telugu to English on 10 Aug 46. The King s College VascuQOL questionnaire dated 12 July ; Back Translated from Malayalam to English on 10 Aug 47. The King s College VascuQOL questionnaire dated 12 July ; Back Translated from Urdu to English on 10 Aug
4 48. The King s College VascuQOL questionnaire - Hindi Back Translation Certificate dated 10 Aug 49. The King s College VascuQOL questionnaire - Kannada Back Translation Certificate dated 10 Aug 50. The King s College VascuQOL questionnaire - Tamil Back Translation Certificate dated 10 Aug 51. The King s College VascuQOL questionnaire - Telugu Back Translation Certificate dated 10 Aug 52. The King s College VascuQOL questionnaire - Malayalam Back Translation Certificate dated 10 Aug 53. The King s College VascuQOL questionnaire - Urdu Back Translation Certificate dated 10 Aug 54. DCGI subissions Letter dated 12 Jul 55. CV of the Investigator dated 28 Jul 56. Investigator s Undertaking date 28 Jul 57. English Visual Analog Scale Version Visual Analog Scale Version 1.0; Translated from English to Hindi on 16 Nov 59. Visual Analog Scale Version 1.0; Translated from English to Kannada on 16 Nov 60. Visual Analog Scale Version 1.0; Translated from English to Tamil on 16 Nov 61. Visual Analog Scale Version 1.0; Translated from English to Telugu on 16 Nov 62. Visual Analog Scale Version 1.0; Translated from English to Malayalam on 16 Nov 63. Visual Analog Scale Version 1.0; Translated from English to Urdu on 16 Nov 64. Visual Analog Scale; Hindi Translation Certificate dated 16 Nov 65. Visual Analog Scale; Kannada Translation Certificate dated 16 Nov 66. Visual Analog Scale; Tamil Translation Certificate dated 16 Nov 67. Visual Analog Scale; Telugu Translation Certificate dated 16 Nov 68. Visual Analog Scale; Malayalam Translation Certificate dated 16 Nov 69. Visual Analog Scale; Urdu Translation Certificate dated 16 Nov 70. Visual Analog Scale Version 1.0; Back Translated from Hindi to English on 17 Nov 71. Visual Analog Scale Version 1.0; Back Translated from Kannada to English on 17 Nov
5 72. Visual Analog Scale Version 1.0; Back Translated from Tamil to English on 17 Nov 73. Visual Analog Scale Version 1.0; Back Translated from Telugu to English on 17 Nov 74. Visual Analog Scale Version 1.0; Back Translated from Malayalam to English on 17 Nov 75. Visual Analog Scale Version 1.0; Back Translated from Urdu to English on 17 Nov 76. Visual Analog Scale Version; Hindi Back Translation Certificate dated 17 Nov 77. Visual Analog Scale Version; Kannada Back Translation Certificate dated 17 Nov 78. Visual Analog Scale Version; Tamil Back Translation Certificate dated 17 Nov 79. Visual Analog Scale Version; Telugu Back Translation Certificate dated 17 Nov 80. Visual Analog Scale Version; Malayalam Back Translation Certificate dated 17 Nov 81. Visual Analog Scale Version; Urdu Back Translation Certificate dated 17 Nov The following members of the Institutional Ethics Committee were present during the meeting held on 23/11/11 on PM at Seminar Hall, Madras Medical College, Chennai. Name Role Prof. S.K. Rajan, MD Chairperson Prof. A. Sundaram, MD Vice Principal, MMC, Chennai -3 Prof R. Nandhini, MD Director, Institute of Pharmacology, MMC, Ch-3 Prof. Pregna B. Dolia, MD Director, Institute of Biochemistry, MMC, Ch-3 Prof. C. Rajendran, MD Director, Institute of Internal Medicine, MMC, Ch-3 Prof. Md. Ali, MD, DM Professor & Head,Dept.of Medical Gastroenterology, MMC, Ch-3 Prof. Shantha Ravishankar MD Prof. Of Neuropathology, MMC, Ch - 3 Thiru. S. Govindasamy BA.BL Secretary Lawyer Tmt. Arnold Soulina Social Scientist
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