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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Parkinson's Disease
• Intervention / Treatment: Biological: mesenchymal stem cells

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: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Hebei Newtherapy BIo-Pharma Technology Co., Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Post cell transplantation: 1, 3, 6, 12months
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.	Post cell transplantation: 1, 3, 6, 12months
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.	Post cell transplantation: 1, 3, 6, 12months
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.	Post cell transplantation: 1, 3, 6, 12months
Adverse reaction	Adverse reaction including temperature changes,the change of blood pressure,allergy and so on.	Post cell transplantation: 1, 3, 6, 12months

Collaborators and Investigators

• Sponsor: Hebei Newtherapy BIo-Pharma technology Co., Ltd.
• Investigators: Study Chair: Xiqing Chai, Doctor, Hebei Chemical & Pharmaceutical College; Study Director: Hongxu Chen, Master, The First Hospital of Hebei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Anticipated): October 10, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: May 11, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (Actual): June 8, 2018

Study Record Updates

• Last Update Posted (Actual): December 30, 2021
• Last Update Submitted That Met QC Criteria: December 29, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 18967728D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No