title: Phase 1 Trial of Autologous Bone Marrow Stem Cell Transplantation in Patients with Spinal Cord Injury.
abstract: Introduction. A total of 18 patients, with complete motor deficits and paraplegia caused by thoracic and lumbar spine trauma without muscle atrophy or psychiatric problems, were included into this study. Materials and Methods. The bone marrow was aspirated from the anterior iliac crest under local anesthesia and the mononuclear fraction was isolated by density gradient method. At least 750 million mononuclear-enriched cells, suspended in 2 mL of saline, were infused intrathecally. Results and Discussion. The study reports demonstrated improvement of motor and sensory functions of various degrees observed in 9 of the 18 (50%) cases after bone marrow stem cell transplantation. Measured by the American Spinal Injury Association (ASIA) scale, 7 (78%) out of the 9 patients observed an improvement by one grade, while two cases (22%) saw an improvement by two grades. However, there were no cases in which the condition was improved by three grades. Conclusions. Analysis of subsequent treatment results indicated that the transplantation of mononuclear-enriched autologous BMSCs is a feasible and safe technique. However, successful application of the BMSCs in the clinical practice is associated with the necessity of executing more detailed examinations to evaluate the effect of BMSCs on the patients with spinal cord injury.
authors.affiliation: Department of Clinical Anatomy, Tbilisi State Medical University, 0177 Tbilisi, Georgia; N. Kipshidze Central University Hospital, 0177 Tbilisi, Georgia.
authors.forename: Zurab
authors.initials: Z
authors.lastname: Kakabadze
authors.affiliation: N. Kipshidze Central University Hospital, 0177 Tbilisi, Georgia; Department of Endovascular Therapy, New York Cardiovascular Research, New York, NY 10128, USA.
authors.forename: Nickolas
authors.identifier: 0000-0003-4892-9591
authors.initials: N
authors.lastname: Kipshidze
authors.affiliation: Department of Cell Therapy and Cancer Immunotherapy, Cancer Research Centre, 0177 Tbilisi, Georgia.
authors.forename: Konstantine
authors.initials: K
authors.lastname: Mardaleishvili
authors.affiliation: Department of Cell Therapy and Cancer Immunotherapy, Cancer Research Centre, 0177 Tbilisi, Georgia.
authors.forename: Gocha
authors.initials: G
authors.lastname: Chutkerashvili
authors.affiliation: Department of Neurosurgery, Archangel St. Michael Multi Profile Clinical Hospital, 0112 Tbilisi, Georgia.
authors.forename: Irakli
authors.initials: I
authors.lastname: Chelishvili
authors.affiliation: Department of Neurosurgery, Ruhr University Bochum, 44801 Bochum, Germany.
authors.forename: Albrecht
authors.initials: A
authors.lastname: Harders
authors.affiliation: Department of Cell Therapy and Cancer Immunotherapy, Cancer Research Centre, 0177 Tbilisi, Georgia.
authors.forename: George
authors.initials: G
authors.lastname: Loladze
authors.affiliation: Department of Cell Therapy and Cancer Immunotherapy, Cancer Research Centre, 0177 Tbilisi, Georgia.
authors.forename: Gocha
authors.initials: G
authors.lastname: Shatirishvili
authors.affiliation: N. Kipshidze Central University Hospital, 0177 Tbilisi, Georgia; College of Global Public Health, New York University, New York, NY 10003, USA.
authors.forename: Nodar
authors.initials: N
authors.lastname: Kipshidze
authors.affiliation: Department of Clinical Anatomy, Tbilisi State Medical University, 0177 Tbilisi, Georgia.
authors.forename: David
authors.initials: D
authors.lastname: Chakhunashvili
authors.affiliation: Department of Clinical Anatomy, Tbilisi State Medical University, 0177 Tbilisi, Georgia; Department of Neurosurgery, Archangel St. Michael Multi Profile Clinical Hospital, 0112 Tbilisi, Georgia.
authors.forename: Konstantine
authors.initials: K
authors.lastname: Chutkerashvili