Progressive Supranuclear Palsy Clinical Trial
Official title:
Autologous Mesenchymal Stem Cell Therapy in Progressive Supranuclear Palsy: a Randomized, Double-blind, Controlled Clinical Trial
There is evidence suggesting that stem cells harvested from the bone marrow and transplanted
into the brain may be effective in slowing down the progression of parkinsonism. Mesenchymal
stem cells are able to produce growth factors that provide support to diseased nervous
cells.
In this study mesenchymal stem cells will be harvested from the bone marrow, cultivated in a
test tube so that they multiply and then infused into the arteries that supply blood to the
brain in 20 patients suffering from a rare form of parkinsonism, Progressive Supranuclear
Palsy. Each patient will undergo two infusions, one with the stem cells and one without, at
an interval of 6 months. The sequence of the two infusions will be assigned randomly;
patients and assessors will not know the sequence (double-blind). Patients will be
followed-up for up to 1 year after the last infusion, with regular assessments to assess
safety, efficacy on motor and cognitive functions, and effects on the brain by neuroimaging
techniques.
The study has a preliminary phase with 5 patients all given stem cell therapy alone,
designed to assess safety
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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