Parkinson's Disease Therapy Using Cell Technology
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|ClinicalTrials.gov Identifier: NCT04146519|
Recruitment Status : Recruiting
First Posted : October 31, 2019
Last Update Posted : March 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Transplantation:Mesenchymal Stem Cell Transplantation||Biological: Autologous mesenchymal stem cells Other: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Developent and Implement a Method of Parkinson's Disease Therapy Using Cell Technology|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Study group
Biological: Autologous mesenchymal stem cells
Autologous mesenchymal stem cells
|Placebo Comparator: control group||
- motor symptoms change [ Time Frame: 3 month ]
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).
- non-motor symptoms change [ Time Frame: 3 month ]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).
- sleep quality change [ Time Frame: 3 month ]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.
- daytime sleepiness change [ Time Frame: 3 month ]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'.
- signs of depression change [ Time Frame: 3 month ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04146519
|Contact: Vladimir Ponomarev, PhDemail@example.com|
|the Belarusian Medical Academy of Postgraduate Education||Recruiting|
|Minsk, Belarus, 220013|
|Contact: Vladimir Ponomarev, PhD 80172959016 firstname.lastname@example.org|