Clinical Study of Adipose-derived Stem Cells in the Treatment of Diabetic Foot

Summary

1. Program Name: Clinical Study on Treatment of Diabetic Foot with Autologous Adipose Stem Cells 2. Bidding Unit: Tenth People's Hospital Affiliated to Tongji University 3. Study subjects: diabetic foot patients 4. OBJECTIVE: To establish an autologous adipose stem cell therapy for diabetic foot and evaluate its clinical safety and efficacy. 5. Study Design: Randomized Controlled Clinical Study 6. Target number of cases: 60 7. Main evaluation indicators: ulcer healing and amputation, calculating ulcer healing rate = total wound healing cases / total ulcer cases in this group; amputation rate = amputation cases / total cases in this group. 8. Secondary evaluation indicators: ankle-brachial index (ABI), Ruthford classification, painless walking time Wong-Baker Faces pain score, transcutaneous partial pressure of oxygen (TcPO2), laser Doppler flowmetry, multi-slice spiral CT angiography (CTA)

Timeline

Start

2019-04-20

Primary completion

2020-01-31

Completion

2020-03-31

Publications

• Background Lu Debin, Jiang Youzhao, Liang Ziwen, Li Xiaoyan, Zhang Zhonghui, Chen Bing.Autologous transplantation of bone marrow mesenchymal stem cells on diabetic patients with lower limb ischemia.Journal of Medical Colleges of PLA 2008;23:106-115
• Background Carlin JB, Doyle LW. Sample size. J Paediatr Child Health. 2002 Jun;38(3):300-4. doi: 10.1046/j.1440-1754.2002.00855.x. No abstract available.
• Background Al-Delaimy WK, Merchant AT, Rimm EB, Willett WC, Stampfer MJ, Hu FB. Effect of type 2 diabetes and its duration on the risk of peripheral arterial disease among men. Am J Med. 2004 Feb 15;116(4):236-40. doi: 10.1016/j.amjmed.2003.09.038.
• Background Khattab AD, Ali IS, Rawlings B. Peripheral arterial disease in diabetic patients selected from a primary care setting: Implications for nursing practice. J Vasc Nurs. 2005 Dec;23(4):139-48. doi: 10.1016/j.jvn.2005.09.005.
• Background Rathur HM, Boulton AJ. The diabetic foot. Clin Dermatol. 2007 Jan-Feb;25(1):109-20. doi: 10.1016/j.clindermatol.2006.09.015.
• Background Dick F, Diehm N, Galimanis A, Husmann M, Schmidli J, Baumgartner I. Surgical or endovascular revascularization in patients with critical limb ischemia: influence of diabetes mellitus on clinical outcome. J Vasc Surg. 2007 Apr;45(4):751-61. doi: 10.1016/j.jvs.2006.12.022. Epub 2007 Feb 15.
• Background Engelhardt M, Bruijnen H, Scharmer C, Jezdinsky N, Wolfle K. Improvement of quality of life six months after infrageniculate bypass surgery: diabetic patients benefit less than non-diabetic patients. Eur J Vasc Endovasc Surg. 2006 Aug;32(2):182-7. doi: 10.1016/j.ejvs.2006.02.007. Epub 2006 Mar 29.
• Background Huang P, Li S, Han M, Xiao Z, Yang R, Han ZC. Autologous transplantation of granulocyte colony-stimulating factor-mobilized peripheral blood mononuclear cells improves critical limb ischemia in diabetes. Diabetes Care. 2005 Sep;28(9):2155-60. doi: 10.2337/diacare.28.9.2155.
• Background Humpert PM, Bartsch U, Konrade I, Hammes HP, Morcos M, Kasper M, Bierhaus A, Nawroth PP. Locally applied mononuclear bone marrow cells restore angiogenesis and promote wound healing in a type 2 diabetic patient. Exp Clin Endocrinol Diabetes. 2005 Oct;113(9):538-40. doi: 10.1055/s-2005-872886.
• Background Canizo MC, Lozano F, Gonzalez-Porras JR, Barros M, Lopez-Holgado N, Briz E, Sanchez-Guijo FM. Peripheral endothelial progenitor cells (CD133 +) for therapeutic vasculogenesis in a patient with critical limb ischemia. One year follow-up. Cytotherapy. 2007;9(1):99-102. doi: 10.1080/14653240601034708.
• Background Kern S, Eichler H, Stoeve J, Kluter H, Bieback K. Comparative analysis of mesenchymal stem cells from bone marrow, umbilical cord blood, or adipose tissue. Stem Cells. 2006 May;24(5):1294-301. doi: 10.1634/stemcells.2005-0342. Epub 2006 Jan 12.
• Background De Ugarte DA, Morizono K, Elbarbary A, Alfonso Z, Zuk PA, Zhu M, Dragoo JL, Ashjian P, Thomas B, Benhaim P, Chen I, Fraser J, Hedrick MH. Comparison of multi-lineage cells from human adipose tissue and bone marrow. Cells Tissues Organs. 2003;174(3):101-9. doi: 10.1159/000071150.
• Background Zuk PA, Zhu M, Ashjian P, De Ugarte DA, Huang JI, Mizuno H, Alfonso ZC, Fraser JK, Benhaim P, Hedrick MH. Human adipose tissue is a source of multipotent stem cells. Mol Biol Cell. 2002 Dec;13(12):4279-95. doi: 10.1091/mbc.e02-02-0105.
• Background Gimble JM, Katz AJ, Bunnell BA. Adipose-derived stem cells for regenerative medicine. Circ Res. 2007 May 11;100(9):1249-60. doi: 10.1161/01.RES.0000265074.83288.09.
• Background Wei Y, Hu H, Wang H, Wu Y, Deng L, Qi J. Cartilage regeneration of adipose-derived stem cells in a hybrid scaffold from fibrin-modified PLGA. Cell Transplant. 2009;18(2):159-70. doi: 10.3727/096368909788341261.

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