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Mesenchymal Stem Cells Transplantation to Patients With Parkinson's Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Guangzhou General Hospital of Guangzhou Military Command.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01446614
First Posted: October 5, 2011
Last Update Posted: October 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Guangzhou General Hospital of Guangzhou Military Command
October 4, 2011
October 5, 2011
October 5, 2011
October 2011
June 2013   (Final data collection date for primary outcome measure)
Number of participants with adverse events [ Time Frame: 1 month after transplantation ]
Same as current
No Changes Posted
  • Effect assessment [ Time Frame: 1 month after transplantation ]
    Assessed by Unified Parkinson's Disease Rating Scale (UPDRS).
  • Effect assessment [ Time Frame: 3 months after transplantation ]
    Assessed by UPDRS
  • Effect assessment [ Time Frame: 6 months after transplantation ]
    Assessed by UPDRS
  • Effect assessment [ Time Frame: 12 months after transplantation ]
    Assessed by UPDRS
Same as current
Not Provided
Not Provided
 
Mesenchymal Stem Cells Transplantation to Patients With Parkinson's Disease
PhaseⅠ/ⅡTrial of Autologous Bone Marrow Derived Mesenchymal Stem Cells to Patients With Parkinson's Disease.
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 disease.

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 likely to be important in producing abnormal protein aggregation within select groups of neurones, leading to cell dysfunction and then death. A large number of agents together with surgical interventions are now available to treat early and late complications of PD, but they are suffer from two main drawbacks: side effects and loss of efficacy with disease progression.

Bone marrow (BM) derived mesenchymal stem cells (MSCs) an differentiate under certain circumstances into cells from various neuronal and glial type lineages; they also exert immunomodulatory effects. PD-derived MSCs are similar to normal MSCs in phenotype, morphology, and multidifferentiation capacity. Moreover, PD-derived MSCs are capable of differentiating into neurons in a specific medium with up to 30% having the characteristics of dopamine cells. These findings indicate that MSCs derived from PD patients' bone marrow may be a promising cell type for cellular therapy.

BM-MSCs cultured with a cocktail of growth factors (containing FGF and BDNF) differentiate into neuronal/glial lineage cells with a predominance of cells expressing astrocytes' markers. They were effective in suppression of chronic EAE in mice and induced neuroprotection, preserving most of the axons in the CNS of successfully-treated animals. Histopathological studies revealed that MSCs could efficiently migrate into the CNS inflamed tissue (both when administered intravenously and intraventricularly) and differentiated into cells expressing neural-glial lineage markers. Such an approach may provide a feasible and practical way for PD.

Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Parkinson's Disease
Biological: bone marrow derived mesenchymal stem cells
Intravenous administration of up to 6x10^5 MSCs per kg,qw,for 4 weeks
Other Names:
  • Mesenchymal Stem Cells
  • Multipotent Mesenchymal Stem Cells
  • Multipotent Mesenchymal Stromal Cells
Experimental: MSC
Intravenous autologous bone marrow derived mesenchymal stem cells infusion to patients with Parkinson's disease.
Intervention: Biological: bone marrow derived mesenchymal stem cells

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
June 2014
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Sexes Eligible for Study: All
30 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01446614
HM-2011-10
Yes
Not Provided
Not Provided
Not Provided
Guangzhou General Hospital of Guangzhou Military Command
Not Provided
Study Director: Yang Xiao, MD Guangzhou General Hospital of Guangzhou Military Command
Guangzhou General Hospital of Guangzhou Military Command
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP