Clinical trial NCT03550183: Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Parkinson's Disease
Official title: Safety and Efficacy Investigation of Patients With Parkinson's Disease by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Parkinson's Disease
Lead sponsor: Hebei Newtherapy BIo-Pharma technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-06-08
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of the Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: Post cell transplantation: 1, 3, 6, 12months
Secondary outcomes:
measure: Changes of in the Hoehn and Yahr staging
timeFrame: Post cell transplantation: 1, 3, 6, 12months
measure: Changes of the Mini-Mental State Examination (MMSE)
timeFrame: Post cell transplantation: 1, 3, 6, 12months
measure: Changes of the Hamilton depression scales 24 (HAMD 24)
timeFrame: Post cell transplantation: 1, 3, 6, 12months
measure: Changes of the Hamilton Anxiety Scale 14 (HAMA-14)
timeFrame: Post cell transplantation: 1, 3, 6, 12months
measure: Adverse reaction
timeFrame: Post cell transplantation: 1, 3, 6, 12months
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Hebei Newtherapy BIo-Pharma Technology Co., Ltd
state: Hebei
Study officials:
affiliation: Hebei Chemical & Pharmaceutical College
name: Xiqing Chai, Doctor
role: STUDY_CHAIR
affiliation: The First Hospital of Hebei Medical University
name: Ping Gu, Doctor
role: STUDY_DIRECTOR
affiliation: The First Hospital of Hebei Medical University
name: Hongxu Chen, Master
role: STUDY_DIRECTOR
References: