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

Hebei Newtherapy Bio-Pharma Technology

Status and phase: Unknown; Phase 1

Conditions: Parkinson's Disease

Treatments: Biological: mesenchymal stem cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT03550183

18967728D

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

mesenchymal stem cells

Experimental group

Description:

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.

Treatment:

Biological: mesenchymal stem cells