Spinal Cord Injury — Mesenchymal Stem Cells Transplantation to Patients With Spinal Cord Injury
Citation(s)
Hernández J, Torres-Espín 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. Review.
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.
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. Epub 2007 Jul 2. Review.
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.
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.
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. Epub 2006 May 19.
PhaseⅠ/ⅡTrial of Autologous Bone Marrow Derived Mesenchymal Stem Cells to Patients With Spinal Cord Injury.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
