Parkinson's Disease Therapy Using Cell Technology

NCT ID: NCT04146519

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2021-12-31

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

Detailed Description

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Conditions

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Transplantation:Mesenchymal Stem Cell Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Study group

Autologous MMSC

Group Type EXPERIMENTAL

Autologous mesenchymal stem cells

Intervention Type BIOLOGICAL

Autologous mesenchymal stem cells

control group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Saline solution

Interventions

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Autologous mesenchymal stem cells

Autologous mesenchymal stem cells

Intervention Type BIOLOGICAL

Placebo

Saline solution

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belarusian Medical Academy of Post-Graduate Education

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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the Belarusian Medical Academy of Postgraduate Education

Minsk, , Belarus

Site Status RECRUITING

Countries

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Belarus

Central Contacts

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Vladimir Ponomarev, PhD

Role: CONTACT

80172959016

Facility Contacts

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Vladimir Ponomarev, PhD

Role: primary

80172959016

References

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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.

Reference Type BACKGROUND
PMID: 33408914 (View on PubMed)

Other Identifiers

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20171292

Identifier Type: -

Identifier Source: org_study_id

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