Transplantation:Mesenchymal Stem Cell TransplantationPhase 2/3NCT04146519
Parkinson's Disease Therapy Using Cell Technology
A Phase 2/3 study testing Autologous mesenchymal stem cells in people with Transplantation:Mesenchymal Stem Cell Transplantation, run by Belarusian Medical Academy of Post-Graduate Education at 1 site in Belarus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Transplantation:Mesenchymal Stem Cell Transplantation
- What is being tested?
- Autologous mesenchymal stem cells
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Jul 2017to 31 Dec 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belarus1 site, 1 recruiting
- Recruiting
the Belarusian Medical Academy of Postgraduate Education
Minsk, 220013
Vladimir Ponomarev, PhD, 80172959016, professor.ponomarev@gmail.com
About this study
Official title: Developent and Implement a Method of Parkinson's Disease Therapy Using Cell Technology
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
- Being tested
- Autologous mesenchymal stem cells, Placebo
- Keywords
- Parkinson's disease, mesenchymal stem cells, intranasal transplantation, intravenous transplantation, tandem transplantation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous mesenchymal stem cellsBiological
Autologous mesenchymal stem cells
PlaceboOther
Saline solution
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Autologous MMSC Receives: Biological: Autologous mesenchymal stem cells |
| control group | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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'.
Measured: 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).
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start1 Jul 2017
- Primary completion1 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transplantation:Mesenchymal Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belarusian Medical Academy of Post-Graduate Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146519
- Sponsor's protocol ID
- 20171292
- Status last verified
- Feb 2021
- First submitted
- 18 Oct 2019
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33408914
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developent and Implement a Method of Parkinson's Disease Therapy Using Cell Technology
- ClinicalTrials.gov ID
- NCT04146519
- Acronym / sponsor ID
- 20171292
- Keywords
- Parkinson's disease, mesenchymal stem cells, intranasal transplantation, intravenous transplantation, tandem transplantation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Belarusian Medical Academy of Post-Graduate EducationUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Biological: Autologous mesenchymal stem cellsAutologous MMSC |
| control group | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous mesenchymal stem cellsAutologous mesenchymal stem cells | Biological | Study group |
| PlaceboSaline solution | Other | control group |
Primary outcome
motor symptoms change
Time frame: 3 month
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
Time frame: 3 month
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
Time frame: 3 month
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
Time frame: 3 month
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
Time frame: 3 month
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Background: PubMed 33408914Boika 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Autologous mesenchymal stem cells in people with Transplantation:Mesenchymal Stem Cell Transplantation, run by Belarusian Medical Academy of Post-Graduate Education at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vladimir Ponomarev, PhD (80172959016, professor.ponomarev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
motor symptoms change (time frame: 3 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04146519, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.