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

This is an interventional treatment trial for Progressive Supranuclear Palsy focused on measuring Progressive Supranuclear palsy, stem cell therapy Read More

Inclusion Criteria:

diagnosis of 'probable Progressive Supranuclear Palsy - Richardson's disease subtype' according to current diagnostic criteria (Litvan et al. 1996 and 2003)

• age at onset at least 40 years;
• disease duration 12 months to 8 years;
• supranuclear ophthalmoplegia;
• postural instability or falls within 3 years from disease onset
• positive MRI for PSP criteria (Quattrone et al, 2008)
• Stable pharmacological treatment for at least 90 days
• Lack of response to chronic levodopa (at least 12-month treatment).
• Able to stand in upright posture without assistance for at least 30 seconds
• Written informed consent (including video taping)

Exclusion Criteria:

• Idiopathic Parkinson's disease;
• Cerebellar ataxia
• Symptomatic autonomic dysfunction
• Evidence of any other neurological disease that could explain signs;
• History of repeated strokes with stepwise progression of parkinsonian features;
• History of major stroke;
• Any history of severe or repeated head injury;
• A history of encephalitis;
• A history of neuroleptic use for a prolonged period of time or within the past 6 months;
• Street-drug related parkinsonism;
• Significant other neurological disease on CT-scan/MRI;
• Oculogyric crises;
• Major signs of corticobasal degeneration;
• Signs of Lewy body disease;
• Other life-threatening disease likely to interfere with the main outcome measure;
• Any clinically significant laboratory abnormality, with the exception of cholesterol, triglycerides and glucose;
• Renal failure (serum creatinine more than 300 mM/l);
• Transaminase elevation more than twice the upper limit of normal;
• Any concomitant disorder associated with bone marrow function impairment
• Any concomitant disorder that requires chronic treatment with immunosuppressors, anti-inflammatory agents, and/or growth factors
• dementia (MMSE < 24 according to Folstein 1975 or defined according to DSM-IV TR criteria)
• any other disorder that could interfere with the evaluation of treatment or that could make intra-arterial infusion inadvisable
• any other features that, according to the investigator, could reduce adherence to protocol procedures or prevent rapid access in case of emergency;
• women of child-bearing age
• participation in another clinical trial with experimental treatment in the last 30 days
• brain MRI evidence of severe vascular abnormalities, space-occupying lesions or normal pressure hydrocephalus