Clinical trial NCT04146519: Parkinson's Disease Therapy Using Cell Technology
Official title: Developent and Implement a Method of Parkinson's Disease Therapy Using Cell Technology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Transplantation:Mesenchymal Stem Cell Transplantation
Keywords: Parkinson's disease
mesenchymal stem cells
intranasal transplantation
intravenous transplantation
tandem transplantation
Lead sponsor: Belarusian Medical Academy of Post-Graduate Education
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: motor symptoms change
timeFrame: 3 month
measure: non-motor symptoms change
timeFrame: 3 month
measure: sleep quality change
timeFrame: 3 month
measure: daytime sleepiness change
timeFrame: 3 month
measure: signs of depression change
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: the Belarusian Medical Academy of Postgraduate Education
Study officials:
References:
citation: 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.