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This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in Parkinson's disease.
Parkinson's disease (PD) is a neurodegenerative movement disorder，which mainly shows up in the elderly. And there is as yet no effective drug treatment. Umbilical cord derived mesenchymal stem cells (UC-MSCs) derived from mesoderm owns strong proliferation ability and multiple differentiation potential. The investigators used UC-MSCs via intravenous infusion to treat PD. With different durations of follow-up, the investigators cleared therapeutic effect, the quality of life and prognostic implications of UC-MSCs on PD through the Unified Parkinson's Disease Rating Scale (UPDRS), revised Hoehn-Yahr（H-Y） staging, Mini-Mental State Examination (MMSE), Hamilton depression scales 24 (HAMD 24), Hamilton Anxiety Scale 14 (HAMA 14) and Clinical Global Impression (CGI). In this research, the investigators seek new therapeutic approaches for PD, and provide clinical evidences for the clinical application of UC-MSCs in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mesenchymal stem cells | Experimental | Selected patients with Parkinson's disease were randomly divided into a therapy group and a control group. Umbilical Cord Derived Mesenchymal Stem Cells(UC-MSCs) at a dose of 10-20 million by intravenous infusion.Patients in the therapy group treated once a week with UC-MSCs. Each course of treatment Lasted 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesenchymal stem cells | Biological | Patients with PD in the therapy group were given UC-MSCs by intravenous infusion and conventional therapy. There was only conventional treatment in the control group. All patients after treatment for 1 month, 3 months, 6 months and 12 months were evaluated respectively the curative effect. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of the Unified Parkinson's Disease Rating Scale (UPDRS) | The UPDRS was assessed to identify the severity of PD. It includes the four-scale structure with a reorganization of the various subscales. This four-scale structure are (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. | Post cell transplantation: 1, 3, 6, 12months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of in the Hoehn and Yahr staging | Hoehn and Yahr (H-Y) staging was used to determine the stage of PD based on clinical findings and functional disability. In H-Y staging is a rating scale measured in an ordinal level. | Post cell transplantation: 1, 3, 6, 12months |
| Changes of the Mini-Mental State Examination (MMSE) |
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Inclusion Criteria:
Exclusion Criteria:
Patients with PD have to be disqualified from this study if any of the following is applicable.
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| Name | Affiliation | Role |
|---|---|---|
| Xiqing Chai, Doctor | Hebei Chemical & Pharmaceutical College | Study Chair |
| Ping Gu, Doctor | The First Hospital of Hebei Medical University | Study Director |
| Hongxu Chen, Master | The First Hospital of Hebei Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Newtherapy BIo-Pharma Technology Co., Ltd | Shijiazhuang | Hebei | 050000 | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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The MMSE was used to measure cognition. This test consists of 2 parts: language and performance. Its total score can range from 0 to 30, with a higher score indicating better function. |
| Post cell transplantation: 1, 3, 6, 12months |
| Changes of the Hamilton depression scales 24 (HAMD 24) | The HAMD 24 is used to assessed the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. There are 24 items in the HAMD 24. | Post cell transplantation: 1, 3, 6, 12months |
| Changes of the Hamilton Anxiety Scale 14 (HAMA-14) | The HAMA-14 is used to assessed the anxiety symptoms. Its total score can range from 0 to 56. Lower score represents a better outcome. | Post cell transplantation: 1, 3, 6, 12months |
| Adverse reaction | Adverse reaction including temperature changes,the change of blood pressure,allergy and so on. | Post cell transplantation: 1, 3, 6, 12months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |