Trial | NCT03550183  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in Parkinson's disease.
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 Started
Jan 10
2018
Primary Completion
Oct 10
2022
Anticipated
Study Completion
Dec 30
2022
Anticipated
Last Update
Dec 30
2021

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.

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.

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.
No Results Posted