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Parkinson's Disease Therapy Using Cell Technology

Primary Purpose

Transplantation:Mesenchymal Stem Cell Transplantation

Status
Unknown status
Phase
Phase 2
Locations
Belarus
Study Type
Interventional
Intervention
Autologous mesenchymal stem cells
Placebo
Sponsored by
Belarusian Medical Academy of Post-Graduate Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transplantation:Mesenchymal Stem Cell Transplantation focused on measuring Parkinson's disease, mesenchymal stem cells, intranasal transplantation, intravenous transplantation, tandem transplantation

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept 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.

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.

Sites / Locations

  • the Belarusian Medical Academy of Postgraduate EducationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study group

control group

Arm Description

Autologous MMSC

Outcomes

Primary Outcome Measures

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).
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).
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.
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'.
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).

Secondary Outcome Measures

Full Information

First Posted
October 18, 2019
Last Updated
February 27, 2021
Sponsor
Belarusian Medical Academy of Post-Graduate Education
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1. Study Identification

Unique Protocol Identification Number
NCT04146519
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Belarusian Medical Academy of Post-Graduate Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transplantation:Mesenchymal Stem Cell Transplantation
Keywords
Parkinson's disease, mesenchymal stem cells, intranasal transplantation, intravenous transplantation, tandem transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Autologous MMSC
Arm Title
control group
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Autologous mesenchymal stem cells
Intervention Description
Autologous mesenchymal stem cells
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Saline solution
Primary Outcome Measure Information:
Title
motor symptoms change
Description
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).
Time Frame
3 month
Title
non-motor symptoms change
Description
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).
Time Frame
3 month
Title
sleep quality change
Description
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.
Time Frame
3 month
Title
daytime sleepiness change
Description
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'.
Time Frame
3 month
Title
signs of depression change
Description
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).
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vladimir Ponomarev, PhD
Phone
80172959016
Email
professor.ponomarev@gmail.com
Facility Information:
Facility Name
the Belarusian Medical Academy of Postgraduate Education
City
Minsk
ZIP/Postal Code
220013
Country
Belarus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir Ponomarev, PhD
Phone
80172959016
Email
professor.ponomarev@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
33408914
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.
Results Reference
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Parkinson's Disease Therapy Using Cell Technology

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