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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 January 2022 |
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Main ID: |
NCT03550183 |
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Date of registration:
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11/05/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Parkinson's Disease
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Scientific title:
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Safety and Efficacy Investigation of Patients With Parkinson's Disease by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells |
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Date of first enrolment:
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January 10, 2018 |
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Target sample size:
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20 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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https://clinicaltrials.gov/show/NCT03550183 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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China
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Contacts
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Name:
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Ping Gu, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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The First Hospital of Hebei Medical University |
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Name:
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Xiqing Chai, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hebei Chemical & Pharmaceutical College |
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Name:
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Hongxu Chen, Master |
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Address:
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Telephone:
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Email:
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Affiliation:
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The First Hospital of Hebei Medical University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
40 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Biological: mesenchymal stem cells
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Primary Outcome(s)
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Changes of the Unified Parkinson's Disease Rating Scale (UPDRS)
[Time Frame: Post cell transplantation: 1, 3, 6, 12months]
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Secondary Outcome(s)
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Adverse reaction
[Time Frame: Post cell transplantation: 1, 3, 6, 12months]
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Changes of the Hamilton Anxiety Scale 14 (HAMA-14)
[Time Frame: Post cell transplantation: 1, 3, 6, 12months]
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Changes of the Hamilton depression scales 24 (HAMD 24)
[Time Frame: Post cell transplantation: 1, 3, 6, 12months]
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Changes of the Mini-Mental State Examination (MMSE)
[Time Frame: Post cell transplantation: 1, 3, 6, 12months]
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Changes of in the Hoehn and Yahr staging
[Time Frame: Post cell transplantation: 1, 3, 6, 12months]
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Secondary ID(s)
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18967728D
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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