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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
Sponsor:
Information provided by (Responsible Party):
Belarusian Medical Academy of Post-Graduate Education

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Transplantation:Mesenchymal Stem Cell Transplantation Biological: Autologous mesenchymal stem cells Other: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study group
Autologous MMSC
Biological: Autologous mesenchymal stem cells
Autologous mesenchymal stem cells

Placebo Comparator: control group Other: Placebo
Saline solution




Primary Outcome Measures :
  1. 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).


  2. 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).

  3. 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.

  4. 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'.

  5. 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).



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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  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:

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.


Information from the National Library of Medicine

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


Contacts
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Contact: Vladimir Ponomarev, PhD 80172959016 professor.ponomarev@gmail.com

Locations
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Belarus
the Belarusian Medical Academy of Postgraduate Education Recruiting
Minsk, Belarus, 220013
Contact: Vladimir Ponomarev, PhD    80172959016    professor.ponomarev@gmail.com   
Sponsors and Collaborators
Belarusian Medical Academy of Post-Graduate Education
Publications:
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Responsible Party: Belarusian Medical Academy of Post-Graduate Education
ClinicalTrials.gov Identifier: NCT04146519    
Other Study ID Numbers: 20171292
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Belarusian Medical Academy of Post-Graduate Education:
Parkinson's disease
mesenchymal stem cells
intranasal transplantation
intravenous transplantation
tandem transplantation
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases