The Effectiveness of Selective Stem Cell Placement on Gait Performance in Patients with Multiple Sclerosis: a Phase I Clinical Trial

Autor: David S. S. Cohen, Henry Broeska
Rok vydání: 2019
Předmět:
Zdroj: International Journal of Pharmaceutical Sciences and Drug Research. 11
ISSN: 0975-248X
DOI: 10.25004/ijpsdr.2019.110301
Popis: Multiple sclerosis (MS) is a chronic and oftentimes disabling disease of the central nervous system. It affects almost 1 million people living in the United States and about 2.5 million people globally. Though the cause is not fully understood, MS occurs through an inflammatory process in the brain. This inflammation results in the destruction of the myelin sheath surrounding the nerves that enable conduction of nerve impulses within the brain and spinal cord. To overcome symptoms, MS patients are usually prescribed disease modifying drug therapies or immunosuppressive drugs for prolonged periods resulting in only temporary clinical improvement. In a large subset of patients, disease progression is measured by the continuing deterioration of physical ability. One of the most reliable measures of disease progression in MS is gait performance. Previous studies have demonstrated that clinically significant gait deviations occur at all stages of MS that involve walking. This report describes a Phase I clinical trial of a novel targeted delivery technique, selectively placing autologous bone marrow mononuclear stem cells into the central vein of multiple sclerosis patients, with post-operative functional changes measured by gait performance. To determine the functional benefit of selective stem cell placement, the timed 25-foot walk was administered to 31 MS patients before and after therapy. The time and number of steps taken to complete the test significantly decreased post-intervention. Currently, disease-modifying and immunosuppressive drugs are the only approved treatments for MS. Comparative trials between disease-modifying and immunosuppressive drugs measure benefit as a slowing of multiple sclerosis manifestations, not an improvement. This trial demonstrated an immediate global improvement in the level of disability as measured by the timed 25-foot walk. This suggests that recovery of function in MS patients is possible. Where pharmaceutical agents only mitigate symptoms and potentially slow disease progression, selective stem cell placement of autologous bone marrow mononuclear stem cells should be considered as a possible treatment for MS due to measured improvement in post-therapy functional ability. Further research is required to validate our findings.
Databáze: OpenAIRE