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Treatment of patients with Parkinson's disease using mesenchymal stem cells is a perspective method to influence on the pathogenesis of the disease. At the same time, this is a complex and still insufficiently explored process. Autologous mesenchymal stem cells will be transplanted to 30 patients with Parkinson's disease. The results of the effectiveness of the combined and intravenous routes of mesenchymal stem cells administration on the motor and non-motor symptoms in these patients will be evaluated and compared with the results of control group that received placebo therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Autologous MMSC |
|
| control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous mesenchymal stem cells | Biological | Autologous mesenchymal stem cells |
| |
| Measure | Description | Time Frame |
|---|---|---|
| motor symptoms change | Positive trend is going to be detected in the overall score of the third part of the UPDRS scale(Unified Parkinson Disease Rating Scale) in the off- and in the on-period:neurological examination of patients in the dynamics is carried out in the morning after a 12 (24) - hour break in taking anti-Parkinsonian drugs "off-state", then one hour after they were taken "on-state". A score of 64 on the third part of the UPDRS scale represents the worst (total motor disability) with a score of zero representing (no disability). | 3 month |
| non-motor symptoms change | Identification and assessment of the severity of non-motor symptoms is carried out using Non-motor Symptoms Questionnaire (PD NMS Questionnaire).A score of 30 represents the worst result with a score of zero representing (no disability). | 3 month |
| sleep quality change | The Pittsburgh Sleep Quality Index (PSQI) is used to assess sleep quality over the last month.The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality. | 3 month |
| daytime sleepiness change | The Epworth Sleepiness Scale (ESS) is used to measure daytime sleepiness.The ESS score can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. | 3 month |
| signs of depression change | We use the Hamilton Depression Scale - Hamilton psychiatric rating scale for depression (HDRS) - to identify signs of depression. A score of 52 represents the worst result with a score of zero representing (no disability). | 3 month |
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Inclusion Criteria:
Exclusion Criteria:
e and parkinsonism-plus. 2. Severe concomitant diseases (congestive heart failure, myocardial infarction, pneumonia, decompensated diabetes mellitus, cachexia, etc.).
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vladimir Ponomarev, PhD | Contact | 80172959016 | professor.ponomarev@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Belarusian Medical Academy of Postgraduate Education | Recruiting | Minsk | 220013 | Belarus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33408914 | Background | 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. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo |
| Other |
Saline solution |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |