Clinical Trial: Clinical Trial to Evaluate Bone Marrow Stem Cell Therapy for PSP, a Rare Form of Parkinsonism

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Autologous Mesenchymal Stem Cell Therapy in Progressive Supranuclear Palsy: a Randomized, Double-blind, Controlled Clinical Trial

Brief Summary:

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


Detailed Summary:
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Current Primary Outcome: incidence of adverse events [ Time Frame: one year ]

incidence of adverse events collected by clinical monitoring and performing routine laboratory tests


Original Primary Outcome: Same as current

Current Secondary Outcome: changes in brain images [ Time Frame: one year ]

change vs baseline in the striatal density of dopamine transporters in SPECT brain images and in the normalized regional cerebral flow / glucose metabolism in the gray matter in PET brain images after one year


Original Secondary Outcome: Same as current

Information By: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Dates:
Date Received: March 31, 2013
Date Started: December 2012
Date Completion: December 2014
Last Updated: March 31, 2013
Last Verified: March 2013