Parkinson's Disease Therapy Using Cell Technology
Developent and Implement a Method of Parkinson's Disease Therapy Using Cell Technology
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2017
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 18, 2019
CompletedFirst Posted
Study publicly available on registry
October 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMarch 3, 2021
February 1, 2021
4.4 years
October 18, 2019
February 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
Study Arms (2)
Study group
EXPERIMENTALAutologous MMSC
control group
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- e and parkinsonism-plus. 2. Severe concomitant diseases (congestive heart failure, myocardial infarction, pneumonia, decompensated diabetes mellitus, cachexia, etc.).
- \. 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.
- \. A positive result for HIV, hepatitis B (HBV), hepatitis C (HCV), syphilis (RW).
- \. Cognitive deficit. 8. Mental disorders - hallucinations, behavior disorders. 9. Depression of a pronounced degree (not more than 19 points on the Hamilton scale).
- \. Alcoholism, drug addiction, criminal liability in the patient's history. 11. Pregnancy, lactation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the Belarusian Medical Academy of Postgraduate Education
Minsk, 220013, Belarus
Related Publications (1)
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.
PMID: 33408914BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2019
First Posted
October 31, 2019
Study Start
July 1, 2017
Primary Completion
December 1, 2021
Study Completion
December 31, 2021
Last Updated
March 3, 2021
Record last verified: 2021-02