NCT03550183

Brief Summary

This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in Parkinson's disease.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2018

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

December 30, 2021

Status Verified

December 1, 2021

Enrollment Period

4.8 years

First QC Date

May 11, 2018

Last Update Submit

December 29, 2021

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Changes of in the Hoehn and Yahr staging

    Post cell transplantation: 1, 3, 6, 12months

  • Changes of the Mini-Mental State Examination (MMSE)

    Post cell transplantation: 1, 3, 6, 12months

  • Changes of the Hamilton depression scales 24 (HAMD 24)

    Post cell transplantation: 1, 3, 6, 12months

  • Changes of the Hamilton Anxiety Scale 14 (HAMA-14)

    Post cell transplantation: 1, 3, 6, 12months

  • Adverse reaction

    Post cell transplantation: 1, 3, 6, 12months

Study Arms (1)

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.

Biological: mesenchymal stem cells

Interventions

mesenchymal stem cellsBIOLOGICAL

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.

mesenchymal stem cells

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei Newtherapy BIo-Pharma Technology Co., Ltd

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Scientist & Professor

Study Record Dates

First Submitted

May 11, 2018

First Posted

June 8, 2018

Study Start

January 10, 2018

Primary Completion

October 10, 2022

Study Completion

December 30, 2022

Last Updated

December 30, 2021

Record last verified: 2021-12

Locations

CN(1)