Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT03550183|
Recruitment Status : Enrolling by invitation
First Posted : June 8, 2018
Last Update Posted : August 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Biological: mesenchymal stem cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy Investigation of Patients With Parkinson's Disease by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells|
|Actual Study Start Date :||January 10, 2018|
|Estimated Primary Completion Date :||May 10, 2021|
|Estimated Study Completion Date :||December 30, 2022|
Experimental: mesenchymal stem cells
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
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.
- Changes of the Unified Parkinson`s Disease Rating Scale (UPDRS) [ Time Frame: Post cell transplantation: 1, 3, 6, 12months ]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.
- Changes of in the Hoehn and Yahr staging [ Time Frame: Post cell transplantation: 1, 3, 6, 12months ]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.
- Changes of the Mini-Mental State Examination (MMSE) [ Time Frame: Post cell transplantation: 1, 3, 6, 12months ]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.
- Changes of the Hamilton depression scales 24 (HAMD 24) [ Time Frame: Post cell transplantation: 1, 3, 6, 12months ]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.
- Changes of the Hamilton Anxiety Scale 14 (HAMA-14) [ Time Frame: Post cell transplantation: 1, 3, 6, 12months ]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.
- Adverse reaction [ Time Frame: Post cell transplantation: 1, 3, 6, 12months ]Adverse reaction including temperature changes,the change of blood pressure,allergy and so on.
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): NCT03550183
|Hebei Newtherapy BIo-Pharma Technology Co., Ltd|
|Shijiazhuang, Hebei, China, 050000|
|Study Chair:||Xiqing Chai, Doctor||Hebei Chemical & Pharmaceutical College|
|Study Director:||Ping Gu, Doctor||The First Hospital of Hebei Medical University|
|Study Director:||Hongxu Chen, Master||The First Hospital of Hebei Medical University|