Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
50 participants
INTERVENTIONAL
2017-07-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Study group
Autologous MMSC
Autologous mesenchymal stem cells
Autologous mesenchymal stem cells
control group
Placebo
Saline solution
Interventions
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Autologous mesenchymal stem cells
Autologous mesenchymal stem cells
Placebo
Saline solution
Eligibility Criteria
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Inclusion Criteria
2. Stage of the disease according to Hen-Yar: 1.5 - 3.0 stage.
3. Rapidly progressive type with a change in the stages of Parkinson's disease in no more than 4 years.
4. A good response to levodopa treatment: a positive dopamine test for assessing motor functions by a total score of section 3 of the UPDRS scale in the on- and off-period (not less than 30%).
5. The duration of the disease is not more than 8 years with the absence of motor fluctuations and dyskinesias.
6. The age of patients is up to 65 years
Exclusion Criteria
3\. Autoimmune diseases, a tendency to bleeding, a history of sepsis. 4. Oncological diseases. 5. The presence of acute or exacerbation of the chronic inflammatory process of the sinuses or oral cavity.
6\. A positive result for HIV, hepatitis B (HBV), hepatitis C (HCV), syphilis (RW).
7\. Cognitive deficit. 8. Mental disorders - hallucinations, behavior disorders. 9. Depression of a pronounced degree (not more than 19 points on the Hamilton scale).
10\. Alcoholism, drug addiction, criminal liability in the patient's history. 11. Pregnancy, lactation.
18 Years
69 Years
ALL
No
Sponsors
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Belarusian Medical Academy of Post-Graduate Education
OTHER
Responsible Party
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Locations
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the Belarusian Medical Academy of Postgraduate Education
Minsk, , Belarus
Countries
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Central Contacts
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Facility Contacts
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References
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Boika A, Aleinikava N, Chyzhyk V, Zafranskaya M, Nizheharodava D, Ponomarev V. Mesenchymal stem cells in Parkinson's disease: Motor and nonmotor symptoms in the early posttransplant period. Surg Neurol Int. 2020 Nov 11;11:380. doi: 10.25259/SNI_233_2020. eCollection 2020.
Other Identifiers
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20171292
Identifier Type: -
Identifier Source: org_study_id
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