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Table 1 Inclusion and exclusion criteria

From: Autologous mesenchymal stem cell therapy for progressive supranuclear palsy: translation into a phase I controlled, randomized clinical study

Inclusion criteria -Diagnosis of ’probable Progressive Supranuclear Palsy - Richardson’s disease subtype’ according to current diagnostic criteria [4; 9], including akinetic-rigid syndrome;
-Age at onset ≥ 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., [30]);
-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 injur;
-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 >300 mM/L);
-Transaminase elevation > twice 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.