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INSTITUTIONAL ETHICS COMMITTEE MADRAS MEDICAL COLLEGE, CHENNAI – 3
Telephone No : 044 25305301 Fax : 044 25363970
CERTIFICATE OF APPROVAL To, Date: 16/12/11 Dr. T. Vidyasagaran H.O.D. Dept. of Vascular Surgery Madras Medical College, Chennai - 600 003 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 2011
2. Efficacy Manual dated 12 Jul 2011
3. Investigator’s Brochure Edition 6.0 dated 30 Apr 2010
4. English Informed Consent Document Version 3.0 dated 12 Jul 2011
5. ICF Version 3.0 dated 12 Jul 2011, Translated from English to Hindi on 02 Aug 2011
6. ICF Version 3.0 dated 12 Jul 2011, Translated from English to Kannada on 02 Aug 2011
7. ICF Version 3.0 dated 12 Jul 2011, Translated from English to Tamil on 04 Aug 2011
8. ICF Version 3.0 dated 12 Jul 2011, Translated from English to Telugu on 02 Aug 2011
9. ICF Version 3.0 dated 12 Jul 2011, Translated from English to Malayalam on 02 Aug
2011
10. ICF Version 3.0 dated 12 Jul 2011, Translated from English to Urdu on 02 Aug 2011
11. ICF - Hindi Translation Certificate dated 02 Aug 2011
12. ICF - Kannada Translation Certificate dated 02 Aug 2011
13. ICF - Tamil Translation Certificate dated 04 Aug 2011
14. ICF - Telugu Translation Certificate dated 02 Aug 2011
15. ICF - Malayalam Translation Certificate dated 02 Aug 2011
16. ICF - Urdu Translation Certificate dated 02 Aug 2011
17. ICF Version 3.0 dated 12 July 2011 ; Back Translation from Hindi to English on 16 Aug
2011
18. ICF Version 3.0 dated 12 July 2011 ; Back Translation from Kannada to English on 16
Aug 2011
19. ICF Version 3.0 dated 12 July 2011 ; Back Translation from Tamil to English on 16 Aug
2011
20. ICF Version 3.0 dated 12 July 2011 ; Back Translation from Telugu to English on 16
Aug 2011
21. ICF Version 3.0 dated 12 July 2011 ; Back Translation from Malayalam to English on 16
Aug 2011
22. ICF Version 3.0 dated 12 July 2011 ; Back Translation from Urdu to English on 16 Aug
2011
23. ICF - Hindi Back Translation Certificate dated 16 Aug 2011
24. ICF - Kannada Back Translation Certificate dated 16 Aug 2011
25. ICF - Tamil Back Translation Certificate dated 16 Aug 2011
26. ICF - Telugu Back Translation Certificate dated 16 Aug 2011
27. ICF - Malayalam Back Translation Certificate dated 16 Aug 2011
28. ICF - Urdu Back Translation Certificate dated 16 Aug 2011
29. The King’s College VascuQOL questionnaire dated 12 Jul 2011
30. The King’s College VascuQOL questionnaire dated 12 Jul 2011, Translated from English
to Hindi on 02 Aug 2011
31. The King’s College VascuQOL questionnaire dated 12 Jul 2011, Translated from English
to Kannada on 02 Aug 2011
32. The King’s College VascuQOL questionnaire dated 12 Jul 2011, Translated from English
to Tamil on 02 Aug 2011
33. The King’s College VascuQOL questionnaire dated 12 Jul 2011, Translated from English
to Telugu on 02 Aug 2011
34. The King’s College VascuQOL questionnaire dated 12 Jul 2011, Translated from English
to Malayalam on 02 Aug 2011
35. The King’s College VascuQOL questionnaire dated 12 Jul 2011, Translated from English
to Urdu on 02 Aug 2011
36. The King’s College VascuQOL questionnaire - Hindi Translation Certificate dated 02
Aug 2011
37. The King’s College VascuQOL questionnaire - Kannada Translation Certificate dated 02
Aug 2011
38. The King’s College VascuQOL questionnaire - Tamil Translation Certificate dated 02
Aug 2011
39. The King’s College VascuQOL questionnaire - Telugu Translation Certificate dated 02
Aug 2011
40. The King’s College VascuQOL questionnaire - Malayalam Translation Certificate dated
02 Aug 2011
41. The King’s College VascuQOL questionnaire - Urdu Translation Certificate dated 02
Aug 2011
42. The King’s College VascuQOL questionnaire dated 12 July 2011 ; Back Translated from
Hindi to English on 10 Aug 2011
43. The King’s College VascuQOL questionnaire dated 12 July 2011 ; Back Translated from
Kannada to English on 10 Aug 2011
44. The King’s College VascuQOL questionnaire dated 12 July 2011 ; Back Translated from
Tamil to English on 10 Aug 2011
45. The King’s College VascuQOL questionnaire dated 12 July 2011 ; Back Translated from
Telugu to English on 10 Aug 2011
46. The King’s College VascuQOL questionnaire dated 12 July 2011 ; Back Translated from
Malayalam to English on 10 Aug 2011
47. The King’s College VascuQOL questionnaire dated 12 July 2011 ; Back Translated from
Urdu to English on 10 Aug 2011
48. The King’s College VascuQOL questionnaire - Hindi Back Translation Certificate dated
10 Aug 2011
49. The King’s College VascuQOL questionnaire - Kannada Back Translation Certificate
dated 10 Aug 2011
50. The King’s College VascuQOL questionnaire - Tamil Back Translation Certificate dated
10 Aug 2011
51. The King’s College VascuQOL questionnaire - Telugu Back Translation Certificate dated
10 Aug 2011
52. The King’s College VascuQOL questionnaire - Malayalam Back Translation Certificate
dated 10 Aug 2011
53. The King’s College VascuQOL questionnaire - Urdu Back Translation Certificate dated
10 Aug 2011
54. DCGI subissions Letter dated 12 Jul 2011
55. CV of the Investigator dated 28 Jul 2011
56. Investigator’s Undertaking date 28 Jul 2011
57. English Visual Analog Scale Version 1.0
58. Visual Analog Scale Version 1.0; Translated from English to Hindi on 16 Nov 2011
59. Visual Analog Scale Version 1.0; Translated from English to Kannada on 16 Nov 2011
60. Visual Analog Scale Version 1.0; Translated from English to Tamil on 16 Nov 2011
61. Visual Analog Scale Version 1.0; Translated from English to Telugu on 16 Nov 2011
62. Visual Analog Scale Version 1.0; Translated from English to Malayalam on 16 Nov 2011
63. Visual Analog Scale Version 1.0; Translated from English to Urdu on 16 Nov 2011
64. Visual Analog Scale; Hindi Translation Certificate dated 16 Nov 2011
65. Visual Analog Scale; Kannada Translation Certificate dated 16 Nov 2011
66. Visual Analog Scale; Tamil Translation Certificate dated 16 Nov 2011
67. Visual Analog Scale; Telugu Translation Certificate dated 16 Nov 2011
68. Visual Analog Scale; Malayalam Translation Certificate dated 16 Nov 2011
69. Visual Analog Scale; Urdu Translation Certificate dated 16 Nov 2011
70. Visual Analog Scale Version 1.0; Back Translated from Hindi to English on 17 Nov 2011
71. Visual Analog Scale Version 1.0; Back Translated from Kannada to English on 17 Nov
2011
72. Visual Analog Scale Version 1.0; Back Translated from Tamil to English on 17 Nov
2011
73. Visual Analog Scale Version 1.0; Back Translated from Telugu to English on 17 Nov
2011
74. Visual Analog Scale Version 1.0; Back Translated from Malayalam to English on 17 Nov
2011
75. Visual Analog Scale Version 1.0; Back Translated from Urdu to English on 17 Nov 2011
76. Visual Analog Scale Version; Hindi Back Translation Certificate dated 17 Nov 2011
77. Visual Analog Scale Version; Kannada Back Translation Certificate dated 17 Nov 2011
78. Visual Analog Scale Version; Tamil Back Translation Certificate dated 17 Nov 2011
79. Visual Analog Scale Version; Telugu Back Translation Certificate dated 17 Nov 2011
80. Visual Analog Scale Version; Malayalam Back Translation Certificate dated 17 Nov
2011
81. Visual Analog Scale Version; Urdu Back Translation Certificate dated 17 Nov 2011
The following members of the Institutional Ethics Committee were present during the meeting held on 23/11/11 on 02.00 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 Member Secretary
Prof R. Nandhini, MD Director, Institute of Pharmacology, MMC, Ch-3 Member
Prof. Pregna B. Dolia , MD Director, Institute of Biochemistry, MMC, Ch-3 Member
Prof. C. Rajendran , MD Director, Institute of Internal Medicine, MMC, Ch-3 Member
Prof. Md. Ali, MD, DM Professor & Head ,Dept.of Medical Gastroenterology,
MMC, Ch-3 Member
Prof. Shantha Ravishankar MD Prof. Of Neuropathology, MMC, Ch - 3 Member
Thiru. S. Govindasamy BA.BL Lawyer
Tmt. Arnold Soulina Social Scientist
