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

Primary Purpose

Parkinson's Disease

Status
Enrolling by invitation
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
mesenchymal stem cells
Sponsored by
Hebei Newtherapy BIo-Pharma technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hebei Newtherapy BIo-Pharma Technology Co., Ltd

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mesenchymal stem cells

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Adverse reaction
Adverse reaction including temperature changes,the change of blood pressure,allergy and so on.

Full Information

First Posted
May 11, 2018
Last Updated
December 29, 2021
Sponsor
Hebei Newtherapy BIo-Pharma technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03550183
Brief Title
Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Parkinson's Disease
Official Title
Safety and Efficacy Investigation of Patients With Parkinson's Disease by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
October 10, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebei Newtherapy BIo-Pharma technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mesenchymal stem cells
Arm Type
Experimental
Arm Description
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 Type
Biological
Intervention Name(s)
mesenchymal stem cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes of the Unified Parkinson's Disease Rating Scale (UPDRS)
Description
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.
Time Frame
Post cell transplantation: 1, 3, 6, 12months
Secondary Outcome Measure Information:
Title
Changes of in the Hoehn and Yahr staging
Description
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.
Time Frame
Post cell transplantation: 1, 3, 6, 12months
Title
Changes of the Mini-Mental State Examination (MMSE)
Description
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.
Time Frame
Post cell transplantation: 1, 3, 6, 12months
Title
Changes of the Hamilton depression scales 24 (HAMD 24)
Description
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.
Time Frame
Post cell transplantation: 1, 3, 6, 12months
Title
Changes of the Hamilton Anxiety Scale 14 (HAMA-14)
Description
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.
Time Frame
Post cell transplantation: 1, 3, 6, 12months
Title
Adverse reaction
Description
Adverse reaction including temperature changes,the change of blood pressure,allergy and so on.
Time Frame
Post cell transplantation: 1, 3, 6, 12months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiqing Chai, Doctor
Organizational Affiliation
Hebei Chemical & Pharmaceutical College
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ping Gu, Doctor
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hongxu Chen, Master
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Hebei Newtherapy BIo-Pharma Technology Co., Ltd
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China

12. IPD Sharing Statement

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

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