Parkinson's Disease Therapy Using Cell Technology

Belarusian Medical Academy of Post-Graduate Education (BELMAPE)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Transplantation:Mesenchymal Stem Cell Transplantation

Treatments: Other: Placebo; Biological: Autologous mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04146519

20171292

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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.

4. A positive result for HIV, hepatitis B (HBV), hepatitis C (HCV), syphilis (RW).

5. Cognitive deficit. 8. Mental disorders - hallucinations, behavior disorders. 9. Depression of a pronounced degree (not more than 19 points on the Hamilton scale).

6. Alcoholism, drug addiction, criminal liability in the patient's history. 11. Pregnancy, lactation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Study group

Experimental group

Description:

Autologous MMSC

Treatment:

Biological: Autologous mesenchymal stem cells

control group

Placebo Comparator group

Treatment:

Other: Placebo