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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03550183
• Other study ID #: 18967728D
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: January 10, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: December 2021
• Source: Hebei Newtherapy BIo-Pharma technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 30, 2022
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
China	Hebei Newtherapy BIo-Pharma Technology Co., Ltd	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Newtherapy BIo-Pharma technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse reaction	Adverse reaction including temperature changes,the change of blood pressure,allergy and so on.	Post cell transplantation: 1, 3, 6, 12months