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Umbilical Cord Derived Mesenchymal Stem Cells Therapy in 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: NCT03550183
Recruitment Status : Enrolling by invitation
First Posted : June 8, 2018
Last Update Posted : December 30, 2021
Sponsor:
Information provided by (Responsible Party):
Shengjun An, Hebei Newtherapy BIo-Pharma technology Co., Ltd.

Tracking Information
First Submitted Date  ICMJE May 11, 2018
First Posted Date  ICMJE June 8, 2018
Last Update Posted Date December 30, 2021
Actual Study Start Date  ICMJE January 10, 2018
Estimated Primary Completion Date October 10, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2018)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Parkinson's Disease
Official Title  ICMJE Safety and Efficacy Investigation of Patients With Parkinson's Disease by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
Brief Summary This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in Parkinson's disease.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Biological: mesenchymal stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 25, 2018)		 20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2022
Estimated Primary Completion Date October 10, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age from 40 to 60 years, and no limitation of gender.
  2. Diagnosis of primary Parkinson's disease(PD) according to Movement Disorder Society (MDS)-PD criteria established in 2015.
  3. Hoehn-Yahr Stages from I to IV stage.
  4. Drugs for anti Parkinson's disease have been taken over 28 days before entering the group.
  5. MMSE score≥25
  6. No antidepressant or antipsychotic drugs were received within 2 weeks.
  7. 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.

  1. Patients with psychiatric history, but depression.
  2. Suicidal tendency or behavior of patients.
  3. Patients with severe cognitive impairment, chronic organ failure or malignant tumor.
  4. 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.
  5. Pregnancy and lactating women.
  6. The patient is taking part in other drug tests, or received other research medication within 90 days before entering the group.
  7. Patients who had quit our study could not enter it again.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03550183
Other Study ID Numbers  ICMJE 18967728D
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Shengjun An, Hebei Newtherapy BIo-Pharma technology Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hebei Newtherapy BIo-Pharma technology Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Hebei Newtherapy BIo-Pharma technology Co., Ltd.
Verification Date December 2021

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