STEMPEUCEL® SAFETY AND TOXICITY
1. Preclinical safety and toxicity evaluation of a pooled, allogeneic human bone marrow-derived mesenchymal stromal cell product – Stempeucel. Ind J Med Res 144, December 2016, pp 852-864
2. Safety Assessment of Human Bone Marrow-derived Mesenchymal Stromal Cells Transplantation in Wistar Rats”. Journal of Clinical and Diagnostic Research. 2017 Sep, Vol-11(9): FF01-FF03
3. Non-Invasive In Vivo Tracking,Biodistribution And Fate Of Human Mesenchymal Stromal Cells (MSCs) In Rat Model” Regenerative Research 3(2) 2014 128-130
4. Impact of passing mesenchymal stem cells through smaller bore size needles for subsequent use in patients for clinical or cosmetic indications J Transl Med. 2012; 10: 229
5. Effect of holding time, temperature and different parenteral solutions on viability and functionality of adult bone marrow-derived mesenchymal stem cells before transplantation. J Tissue EngRegen Med (2008), 2(7):436-44
STEMPEUCEL® CRITICAL LIMB ISCHEMIA
6. Development of a surrogate potency assay to determine the angiogenic activity of Stempeucel®, a pooled, ex-vivo expanded, allogeneic human bone marrow mesenchymal stromal cell product. Stem Cell Research &Therapy (2017) 8:47
7. Administration of Adult Human Bone Marrow Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells in Critical Limb Ischemia Due to Buerger’s Disease: Phase II Study Report Suggests Clinical Efficacy” Stem Cells Translational Medicine 2016;5:1–11.
8. Mesenchymal Stem Cell Therapy for Peripheral Vascular Diseases Chapter in Stem Cell Biology and Regenerative Medicine Stem Cell Biology and Regenerative Medicine, DOI 10.1007/978-1-62703-200-1_18,©
9. The role of mesenchymal stem cells in the management of critical limb ischemia. In, The Biology and Therapeutic Application of Mesenchymal Cells. Ed K. Atkinson. John Wiley and Sons Inc. Hoboken, New Jersey, USA. 2016.
10. Double Blind Randomized Placebo Controlled Phase I/II study assessing the safety and efficacy of Allogeneic Bone Marrow Derived Mesenchymal Stem Cell in Critical Limb Ischemia. J Transl Med. 2013 Jun 10;11:143. doi: 10.1186/1479-5876-11-143
11. Intra arterialAllogeneicmesenchymal stem cells for critical limb ischemia are safe and efficacious: Report of a Phase I study. J Transl Med. 2013; 11: 143.
12. Cell therapy in critical limb ischemia: current developments and future progress. Cytotherapy Volume 14, Issue 8, September 2012, Pages 902–916
13. Stem cell therapy for critical limb ischemia – a review: Indian J Surg. 2009 Aug;71(4):177-81. doi: 10.1007/s12262-009-0059-7. Epub 2009 Sep 2
14. Efficacy and safety of adult human bone marrow-derived, cultured, pooled, allogeneic mesenchymal stromal cells (Stempeucel®): preclinical and clinical trial in osteoarthritis of the knee joint. Arthritis Research & Therapy 2017. DOI 10.1186/s13075-016-1195-7.
15. Mesenchymal Stem Cells for Cartilage Repair in Osteoarthritis. Stem Cell Research& Therapy)- 3:25 (9 July 2012)
STEMPEUCEL® LIVER CIRRHOSIS
16. Transplantation of human bone marrow mesenchymal stromal cells reduces liver fibrosis more effectively than Wharton's Jelly cells. Stem Cell Research & Therapy (2017) SCRT-D-16-00502R1
17. Therapeutic Potential of Human Bone Marrow Derived Mesenchymal Stromal Cells in Combination with Silymarin against Carbon Tetrachloride Induced Liver Cirrhosis in Wistar Rats. JKIMSU, Vol. 6, No. 4, October-December 2017
STEMPEUCEL® ACUTE MYOCARDIAL INFARCTION
18. Randomized, double-blind, phase I/II study of intravenous allogeneic mesenchymal stromal cells in acute myocardial infarction. Cytotherapy, 2014; 0: 1-12 ( Dec 2014)
STEMPEUCEL® CEREBRAL STROKE AND SPINAL CORD INJURY
19. Functional recovery after transplantation of bone marrow-derived human mesenchymal stromal cells in a rat model of spinal cord injury. Cytotherapy, 12(6), 792-806
20. Stem Cells in Stroke Repair: Current Success & Future Prospects. CNS NeurolDisord Drug Targets. 10: 741-756
21. Current status and prospective applications of stem cell-based therapy for spinal cord injury: A challenge for contemporary neurobiology: Curr. Stem Cell Res Ther. 6(2): 93-104
STEMPEUCEL® DIABETIC FOOT ULCER
22. Emerging treatment option for diabetic wounds - Regenerative Medicine: Laboratory to Clinic. Springer SBM, Singapore. 2017
STEMPEUCEL® GENERAL CHARACTERISTICS AND REVIEWS
23. Isolation, expansion and characterization of bone marrow derived stem cells in serum free conditions. Journal of Cell and Tissue Research, 2014 Apr;356(1):123-35. doi: 10.1007/s00441-013-1783-7. Epub 2014 Jan 23. PubMed PMID: 24448665
24. Serum-free media for the production of human mesenchymal stromal cells: a review. Cell Prolif. 2013 Sep 30. doi: 10.1111/cpr.12063. [Epub ahead of print] PubMed PMID: 24118248.
25. Effect of bFGF on HLA-DR expression of human Bone Marrow derived Mesenchymal Stem Cells. Journal of Stem cells, Volume 8 Issue 1.
26. Large-scale expansion of pre-isolated bone marrow mesenchymal stromal cells in serum-free conditions. J Tissue EngRegen Med. 2013 Mar 12. doi: 10.1002/term.1713. [Epub ahead of print] PubMed 2349522
27. Comparative cellular and molecular analyses of pooled bone marrow multipotentmesenchymal stromal cells during continues passaging and after successive cryopreservation. J Cell Biochem. 2012 Oct;113(10):3153-64. doi: 10.1002/jcb.24193
28. Human platelet lysate is an alternative to fetal bovine serum for large-scale expansion of bone marrow-derived mesenchymal stromal cells. BiotechnolLett. 2012 Jul; 34(7):1367-74. doi: 10.1007/s10529-012-0893-8. Epub 2012 Apr 4. PubMed PMID: 22476583
29. Comparison of Chemokine and Receptor Gene Expression between Wharton’s Jelly and Bone Marrow Derived Mesenchymal Stem Cells. Cytotherapy 11/2011; 14(1):26-33
30. Randomised Clinical trials in Surgery: a look at the ethical and practical issues Indian J of Surgery, & 3: 245-250 (DOI 10.1007/s12262-011-0307-5)
31. Treat the graft to improve the regenerative ability of the host. Med Hypotheses, April; 776(4):599-601
32. Adult Stem Cells: A Clinical Update. J Stem Cells. 2009;4(2):105-21
33. Phenotypic and functional comparison of optimum culture conditions for upscaling of bone marrow-derived mesenchymal stem cells. J Tissue EngRegen Med. 2009 Mar;3(3):163-74. doi: 10.1002/term.143
34. MSC: Biology, Culture optimization and potential clinical use. Chapter in Book Stem cells: Basic and Applications edited by Kaushik Deb and Satish Totey
35. Stem Cell Biology and Application. Book entitled Application of Flow Cytometry in Stem Cell research and Tissue Regeneration. Aug 2010 WILEY Inc. Publishers; Chapter 2
36. Pro-Inflammatory Cytokines, IFNγ and TNFα, Influence Immune Properties of Human Bone Marrow and Wharton Jelly Mesenchymal Stem Cells Differentially. PLoS One. 2010 Feb 2;5(2):e9016. doi: 10.1371/journal.pone.0009016 37. Adult Stem Cells: A Clinical Update. J Stem Cells. 2009;4(2):105-21
37. Amirthalingam. M, Seetharam R N. Stem Cell Derived Cosmetic Products: An overview- Review article Manipal Journal of Medical Sciences | December 2016 | Volume 1 | Issue 21. Amirthalingam. M, Seetharam R N. Stem Cell Derived Cosmetic Products: An overview- Review article Manipal Journal of Medical Sciences | December 2016 | Volume 1 | Issue 2
38. Balasubramanian S, Thej C, Walvekar A, Swamynathan P, Gupta PK, Seetharam RN, Majumdar AS, "Evaluation of the secretome profile and functional characteristics of human Bone Marrow Mesenchymal Stromal Cells (BMMSC) derived conditioned medium suggest potential for skin rejuvenation"Journal of Cosmetics, Dermatological Sciences and Applications, 2017, 7, 99-117
39. Sachdev M, Chullikana A, Seetharam R N, Shilpakar R, Sapna R, Velugotla.K, Ritambhara,. Majumdar AS, Gupta PK "A Single Arm, Monocentric, Prospective, Open Label Study to Evaluate Anti-Ageing Efficacy of Human Growth Factors and Cytokines Containing Cosmetic Skin Serum in Indian Female Population"Journal of Cosmetics, Dermatological Sciences and Applications, 2017, 7, 118-132.
40. SundarRaj S, Deshmukh A, Priya N, Krishnan VS, Cherat M, and Majumdar AS, "Development of a System and Method for Automated Isolation of Stromal Vascular Fraction from Adipose Tissue Lipoaspirate," Stem Cells International, 2015. doi:10.1155/2015/109353
41. Bora P and Majumdar AS, "Adipose tissue-derived stromal vascular fraction in regenerativemedicine: a brief review on biology and translation", Stem Cell Research and Therapy, 2017. doi: 10.1186/s13287-017-0598-y.