Status:
UNKNOWN
Mesenchymal Stem Cells Transplantation to Patients With Parkinson's Disease
Lead Sponsor:
Guangzhou General Hospital of Guangzhou Military Command
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The study is a phase I/II trial designed to establish the safety and efficacy of intravenous administration of autologous bone marrow derived mesenchymal stem cells to patients with Parkinson's diseas...
Detailed Description
Parkinson's disease (PD) is a common progressive neurodegenerative disorder caused by the loss of dopaminergic neurons in the substantia nigra. A combination of genetic and environmental factors is li...
Eligibility Criteria
Inclusion
- Patient with current diagnosis of idiopathic Parkinson's disease.
- Age 30 to 65.
- Experiencing motor complications despite optimized levodopa treatment.
- PD of Stage 2，2.5，3 or 4 of Hoehn-Yahr staging.
- Time between diagnosis and enrollment greater than 2 years.
- No significant cognitive impairment. MMSE \> 24.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Patients may not be receiving any other investigational agents within 4 weeks of study entry.
- History of allergic reactions attributed to compounds of similar biologic composition to mesenchymal stem cells.
- Primary hematologic diseases.
- Patients undergo intracranial surgeries or implantation of a device for Parkinson's disease.
- Psychiatric, addictive or any other disorder that compromises ability to give a truly informed consent and perform all study assessments.
- Atypical or secondary parkinsonism.
- Malignancy within the last 5 years.
- Any other serious medical illness that might preclude safe participation in the study.
- Pregnant or breastfeeding women.
- HIV-positive patients.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01446614
Start Date
October 1 2011
End Date
June 1 2014
Last Update
October 5 2011
Active Locations (1)
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1
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, China, 510010