Selective Neuropsychological and Functional Improvement in Chronic Severe Traumatic Brain Injury Using Streptolysin O: A Case Report

Background: A non-hemolytic form of streptolysin O (ML-05) can promote wound healing, decrease inflammation and alleviate fibrosis. It was hypothesized that ML-05 could promote neuronal cell survival and recovery in patients with traumatic brain injury (TBI). Methods: A 58-year-old female was treated with ML-05 beginning eleven years after incurring severe automobile accident-related TBI. The patient self-administered sublingual ML-05 (32 ng/ml, 50 ul/dose, 4X/day for 36 months). Relative Change Index (RCI), IQ, neuropsychological, Minnesota Multiphasic Personality Inventory (MMPI-2-RF), Rey Complex Figure Test (RCFT) and self-assessments were made pre-ML-05 and again five and 31 months after initiation of dosing. Results: At five months, the RCI showed improvement in eight of nine cognitive domains, though statistical significance (p<0.05) was only achieved for visual memory. Neuropsychological testing showed modest improvement and stability by 36 months. IQ improved from 88 to 98 in 36 months. There were statistically significant improvements in multiple MMPI-2-RF categories at 36 months. RCFT drawings markedly improved. Adaptive functioning improved. No side effects were reported. Conclusion: Sublingual administration of ML-05 appeared to be safe and potentially useful in a patient with neurological impairment after TBI. Further clinical studies are needed for better understanding the value of ML-05 in treating other TBI patients.