Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
Transplantation of Autologous Peripheral Blood Mononuclear Cells in the Subarachnoid Space for Amyotrophic Lateral Sclerosis: a Safety Analysis of 14 Patients
To assess the safety of peripheral blood mononuclear cell transplantation into the subarachnoid space for the treatment of amyotrophic lateral sclerosis.
Amyotrophic lateral sclerosis (ALS) is a rapidly evolving, fatal neurodegenerative disease
resulting from the degeneration of cortical, bulbar and spinal motor neurons. The disease
progresses inexorably to death, usually because by failure of respiratory function, with a
median duration of 3 years.
Recent clinical trials using various types of stem cells, including mesenchymal stromal
cells, neural stem cells, and peripheral blood mononuclear cells (PBMCs), represent promising
strategies for stem cell-based treatment in ALS. It has been demonstrated that the
inflammation and neuronal death were reduced in ALS patients after bone marrow
transplantation. In addition, the incidence of immune response was decreased by autologous
transplantation of bone marrow cells in ALS patients. PBMCs are multi-potent stem cells that
are very attractive for a cell therapy approach in ALS because of their plasticity and
ability to provide the host tissue with growth factors or modulate the host immune system.
PBMCs were used clinically and few adverse effects were attributed to their administration.
Early clinical investigations indicated that the transplantation of autologous PBMCs into the
dura is feasible in ALS patients; however, one study was limited to three patients and the
other recruited eight patients. There are still many questions regarding the intrathecal
transplantation of PBMCs for ALS. Therefore, a retrospective study was performed to assess
further the safety and efficacy of the procedure and to test the impact of a cell therapy
approach in ALS patients.
Statistical analysis Data, expressed as the mean ± SD, were analyzed using SPSS version 17.0
for Windows (SPSS Inc., Chicago, IL, USA). Statistical analyses were performed by paired
sample t-test. A value of P < 0.05 was considered statistically significant.
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