Parkinson's Disease Therapy Using Cell Technology

Study Overview
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Brief Summary
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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

Official Title
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Developent and Implement a Method of Parkinson's Disease Therapy Using Cell Technology

Conditions
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Transplantation:Mesenchymal Stem Cell Transplantation

Intervention / Treatment
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* Biological: Autologous mesenchymal stem cells
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A reliable diagnosis of Parkinson's disease, according to the diagnostic criteria developed by the Brain Bank of the Society for Parkinson's disease of Great Britain (UK Brain Bank Criteria, 1992). Stage of the disease according to Hen-Yar: 1.5 - 3.0 stage. Rapidly progressive type with a change in the stages of Parkinson's disease in no more than 4 years. 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%). The duration of the disease is not more than 8 years with the absence of motor fluctuations and dyskinesias. The age of patients is up to 65 years 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Autologous MMSC | Biological: Autologous mesenchymal stem cells<br>* Autologous mesenchymal stem cells<br>|
| Placebo Comparator: control group<br> | Other: Placebo<br>* Saline solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, mesenchymal stem cells, intranasal transplantation, intravenous transplantation, tandem transplantation