Human Embryonic Stem Cells in Treatment of Spinal Cord Injury: A Prospective Study

Abstract

Background: Spinal cord injury (SCI) is a devastating disease which impacts the patient physically, psychologically and financially. Although the pharmacological and non-pharmacological methods are used, none of them are able to improve the quality of life permanently. Recent advancement in the regenerative medicines has risen a new dawn for treatment of SCI. Method: In the current study, human embryonic stem cells (hESCs) were used on pre-diagnosed chronic SCI patients with informed written and video consent. The cell lines were cultured and maintained in a good manufacturing practice (GMP), good laboratory practice (GLP), and good tissue practice (GTP) compliance laboratory which were free of animal product and chromosomally stable. The patients were scored according to the American Spinal Injury Association (ASIA) scale. There were four treatment phases (T1, T2, T3 and T4) with gap phases. Patient received 0.25 mL of hESCs through intramuscular (IM) route twice daily, 1 mL of hESCs every 10 days through intravenous (IV) route and 1 - 5 mL of hESCs for 5 - 7 days through supplemental routes. Magnetic resonance imaging (MRI) tractography was performed for all the patients before and after the therapy. Result: Of 11 patients at the beginning of therapy, seven patients were on ASIA score A, one patient was on ASIA score B, two patients were on ASIA score C and one patient was on ASIA score D. At the end of treatment, three patients moved to lower scale, i.e. ASIA score D, two patients to ASIA score C and rest all the patients were on ASIA score A. There was a remarkable improvement in the signs and symptoms of patients clinically. No adverse event and teratoma formation was observed. Conclusion: hESC therapy showed remarkable improvement in the clinical symptoms in SCI patients. J Neurol Res. 2015;5(3):213-220 doi: http://dx.doi.org/10.14740/jnr339w