Mesenchymal Stem Cells Transplantation to Patients With Spinal Cord Injury

Summary

The study is a phase I/II trial designed to establish the safety and efficacy of intravenous combined with intrathecal administration of autologous bone marrow derived mesenchymal stem cells to patients with spinal cord injury.

Timeline

Start

2011-10

Primary completion

2013-06

Completion

2014-06

Publications

• Background Hernandez J, Torres-Espin A, Navarro X. Adult stem cell transplants for spinal cord injury repair: current state in preclinical research. Curr Stem Cell Res Ther. 2011 Sep;6(3):273-87. doi: 10.2174/157488811796575323.
• Background Paul C, Samdani AF, Betz RR, Fischer I, Neuhuber B. Grafting of human bone marrow stromal cells into spinal cord injury: a comparison of delivery methods. Spine (Phila Pa 1976). 2009 Feb 15;34(4):328-34. doi: 10.1097/BRS.0b013e31819403ce.
• Background Sheth RN, Manzano G, Li X, Levi AD. Transplantation of human bone marrow-derived stromal cells into the contused spinal cord of nude rats. J Neurosurg Spine. 2008 Feb;8(2):153-62. doi: 10.3171/SPI/2008/8/2/153.
• Background Zurita M, Vaquero J. Bone marrow stromal cells can achieve cure of chronic paraplegic rats: functional and morphological outcome one year after transplantation. Neurosci Lett. 2006 Jul 10;402(1-2):51-6. doi: 10.1016/j.neulet.2006.03.069. Epub 2006 May 19.
• Background Yoon SH, Shim YS, Park YH, Chung JK, Nam JH, Kim MO, Park HC, Park SR, Min BH, Kim EY, Choi BH, Park H, Ha Y. Complete spinal cord injury treatment using autologous bone marrow cell transplantation and bone marrow stimulation with granulocyte macrophage-colony stimulating factor: Phase I/II clinical trial. Stem Cells. 2007 Aug;25(8):2066-73. doi: 10.1634/stemcells.2006-0807. Epub 2007 Apr 26.
• Background Osaka M, Honmou O, Murakami T, Nonaka T, Houkin K, Hamada H, Kocsis JD. Intravenous administration of mesenchymal stem cells derived from bone marrow after contusive spinal cord injury improves functional outcome. Brain Res. 2010 Jul 9;1343:226-35. doi: 10.1016/j.brainres.2010.05.011. Epub 2010 May 12.
• Background Hu SL, Luo HS, Li JT, Xia YZ, Li L, Zhang LJ, Meng H, Cui GY, Chen Z, Wu N, Lin JK, Zhu G, Feng H. Functional recovery in acute traumatic spinal cord injury after transplantation of human umbilical cord mesenchymal stem cells. Crit Care Med. 2010 Nov;38(11):2181-9. doi: 10.1097/CCM.0b013e3181f17c0e.
• Background Parr AM, Tator CH, Keating A. Bone marrow-derived mesenchymal stromal cells for the repair of central nervous system injury. Bone Marrow Transplant. 2007 Oct;40(7):609-19. doi: 10.1038/sj.bmt.1705757. Epub 2007 Jul 2.

Drugs

Indications