Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Efficacy Investigation of Patients With Parkinson's Disease by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Biological: mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 40 to 60 years, and no limitation of gender. Diagnosis of primary Parkinson's disease(PD) according to Movement Disorder Society (MDS)-PD criteria established in 2015. Hoehn-Yahr Stages from I to IV stage. Drugs for anti Parkinson's disease have been taken over 28 days before entering the group. MMSE score≥25 No antidepressant or antipsychotic drugs were received within 2 weeks. Understanding and willingness to sign a written informed consent document. Exclusion Criteria: Patients with PD have to be disqualified from this study if any of the following is applicable. Patients with psychiatric history, but depression. Suicidal tendency or behavior of patients. Patients with severe cognitive impairment, chronic organ failure or malignant tumor. The value of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) was 1.5 times higher than that of the normal reference; or leucocyte count<1000/μl. Pregnancy and lactating women. The patient is taking part in other drug tests, or received other research medication within 90 days before entering the group. Patients who had quit our study could not enter it again.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mesenchymal stem cells<br>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. | Biological: mesenchymal stem cells<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |