Safety and Efficacy Investigation of Patients With Parkinson's Disease by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- Hebei Newtherapy BIo-Pharma technology Co., Ltd.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Changes of the Unified Parkinson's Disease Rating Scale (UPDRS)
- Last Updated
- 4 years ago
Overview
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.
Investigators
Shengjun An
Principal Scientist & Professor
Hebei Newtherapy BIo-Pharma technology Co., Ltd.
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Changes of the Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame: 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 Outcomes
- Changes of in the Hoehn and Yahr staging(Post cell transplantation: 1, 3, 6, 12months)
- Adverse reaction(Post cell transplantation: 1, 3, 6, 12months)
- Changes of the Mini-Mental State Examination (MMSE)(Post cell transplantation: 1, 3, 6, 12months)
- Changes of the Hamilton Anxiety Scale 14 (HAMA-14)(Post cell transplantation: 1, 3, 6, 12months)
- Changes of the Hamilton depression scales 24 (HAMD 24)(Post cell transplantation: 1, 3, 6, 12months)