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

Phase 1

• Conditions: Parkinson's Disease
• Interventions: Biological: mesenchymal stem cells

• Registration Number: NCT03550183
• Lead Sponsor: Hebei Newtherapy BIo-Pharma technology Co., Ltd.

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 Timeline

• Study Start: 2018-01-10
• Study First Submitted: 2018-05-11
• Study First Submitted QC: 2018-05-25
• Study First Posted: 2018-06-08
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-29
• Last Update Posted: 2021-12-30
• Primary Completion: 2022-10-10
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mesenchymal stem cells	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.

Primary Outcome Measures

Name	Time	Method
Changes of the Unified Parkinson's Disease Rating Scale (UPDRS)	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.

Secondary Outcome Measures

Name	Time	Method
Changes of in the Hoehn and Yahr staging	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.
Adverse reaction	Post cell transplantation: 1, 3, 6, 12months	Adverse reaction including temperature changes,the change of blood pressure,allergy and so on.
Changes of the Mini-Mental State Examination (MMSE)	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 Anxiety Scale 14 (HAMA-14)	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.
Changes of the Hamilton depression scales 24 (HAMD 24)	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.

Trial Locations

Locations (1)

Hebei Newtherapy BIo-Pharma Technology Co., Ltd; 🇨🇳 Shijiazhuang, Hebei, China