Mesenchymal Stem Cells Transplantation to Patients With Parkinson's Disease
|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.|
|ClinicalTrials.gov Identifier: NCT01446614|
Recruitment Status : Unknown
Verified October 2011 by Guangzhou General Hospital of Guangzhou Military Command.
Recruitment status was: Recruiting
First Posted : October 5, 2011
Last Update Posted : October 5, 2011
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Biological: bone marrow derived mesenchymal stem cells||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PhaseⅠ/ⅡTrial of Autologous Bone Marrow Derived Mesenchymal Stem Cells to Patients With Parkinson's Disease.|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||June 2014|
Intravenous autologous bone marrow derived mesenchymal stem cells infusion to patients with Parkinson's disease.
Biological: bone marrow derived mesenchymal stem cells
Intravenous administration of up to 6x10^5 MSCs per kg,qw,for 4 weeks
- Number of participants with adverse events [ Time Frame: 1 month after transplantation ]
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446614
|Contact: Yang Xiao, MDfirstname.lastname@example.org|
|Contact: Li Li, MD||86-20-36653562||Lily17155@yahoo.com|
|Guangzhou General Hospital of Guangzhou Military Command||Recruiting|
|Guangzhou, Guangdong, China, 510010|
|Contact: Yang Xiao, MD 86-20-36653562 email@example.com|
|Contact: Li Li, MD 86-20-36654678 Lily17155@yahoo.com|
|Study Director:||Yang Xiao, MD||Guangzhou General Hospital of Guangzhou Military Command|