Status:
UNKNOWN
Clinical Trial to Evaluate Bone Marrow Stem Cell Therapy for PSP, a Rare Form of Parkinsonism
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Progressive Supranuclear Palsy
Eligibility:
All Genders
40+ years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01824121
Start Date
December 1 2012
End Date
December 1 2014
Last Update
April 4 2013
Active Locations (1)
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1
ICP Parkinson Institute
Milan, Italy, 20126