Multiple System AtrophyNCT04495582
Long-term Follow-up of Phase 1 Clinical Trial of CS10BR05(CS10BR05-MSA101)
An observational study of Multiple System Atrophy, run by Corestemchemon, Inc. at 1 site in South Korea.
Trial summary
The study purpose is conducting follow-up surveillance for the incidence of adverse events and efficacy of subjects participated in phase 1 trial to evaluate the safety and tolerability of autologous bone marrow-derived mesenchymal stem cells (CS10BR05) in subjects with Multiple System Atrophy until 60 months from… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple System Atrophy
- How many people
- 8 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Aug 2018to 25 Sep 2024
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: The subjects who participated in the phase 1 clinical trial(NCT03265444, Protocol No.: CS10BR05-MSA101) will be enrolled in this study, so the number of enrolled subjects will depend on the number of actual enrolled subjects for the phase 1 clinical trial.
Who may be able to join
- Subjects who participated in the phase 1 clinical trial(Protocol No.: CS10BR05- MSA101) at 3 months after administering investigational product
- Subjects who give a written, signed and dated informed consent spontaneously
Who cannot join
- Subjects who decided as inappropriate cases to participate in the observational study by investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of Long-term Safety and Efficacy of Subjects Who Participated in CS10BR05 Inj. Phase 1 Study
The study purpose is conducting follow-up surveillance for the incidence of adverse events and efficacy of subjects participated in phase 1 trial to evaluate the safety and tolerability of autologous bone marrow-derived mesenchymal stem cells (CS10BR05) in subjects with Multiple System Atrophy until 60 months from administering investigational product (IP).
Read the detailed description
Multiple system atrophy is a neurodegenerative disease of the central nervous system which is accompanied by signs of autonomic imbalance (orthostatic hypotension, urinary problems and erectile dysfunction), Parkinson's symptoms (movement decreases and limb tremors) and cerebellar ataxia symptoms (grogginess and incorrect pronunciation). It shows signs similar to Parkinson's disease, however, it doesn't show improvement of symptoms by dopaminergic drugs and occurs at any age.
The purpose is conducting follow-up surveillance for the incidence of adverse events and efficacy of subjects participated in phase 1 trial to evaluate the safety and tolerability of autologous bone marrow-derived mesenchymal stem cells (CS10BR05) in subjects with Multiple System Atrophy until 60 months from administering investigational product (IP).
Because it is the following observational study for subjects participated in phase 1 trial, there is no additional administration of the investigational product in the study.
If the subjects who participated in phase 1 trial voluntarily consent in writing to take part in this observational study, the subjects visit the institution according to the protocol that designed the follow-up visits every 3 months (Visit 1, Visit 2) until 6 months from administration of investigational product and since then 6 months later (Visit 3), every 12 months (Visit 4~7) to observe the incidence of adverse events and efficacy.
As a result of evaluating severity of AE divided into subjective, objective in accordance with the CTCAE (Version 4.0) standards.
- Conditions
- Multiple System Atrophy
- Keywords
- Mesenchymal stem cell, Cell therapy, Multiple system atrophy, Neuroprotection, CS10BR05, Long-term Safety Study
- Medical subject headings
- Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-Interventional Study group | Subjects participating in this observational study originally participated in CS10BR05 Inj. phase 1 study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment(evaluation)
- Adverse events(AE): After the completion of the CS10BR05-MSA101 phase 1 trial, new adverse events, including tumor are assessed and detailed information is collected at each visit. Whole body PET test is performed for tumor observation at visit 7.
- Laboratory test: The following laboratory tests are performed at each visit.
- Hematology test: WBC, RBC, Hemoglobin, Hematocrit, Platelets count, WBC Diffcount
- Chemistry test: Na, K, Ca, Cl, BUN, Creatinine, Uric acid, Total bilirubin, Albumin, Total protein, Creatine Kinase, Cystatin-C, ALT, AST, r-GT, ALP, LDH, Glucose, Total cholesterol, Triglyceride
- Urine test: Protein, Glucose, Urobilinogen, WBC, RBC
- Measuring vital signs (blood pressure in mmHg, heart rate in bpm, body temperature in Celsius) is performed at each visit.
- Physical examination is performed at each visit. If clinically significant abnormal findings are recorded in the CRF and collected as AEs.
Measured: 5 years
Efficacy assessment(evaluation)
The following tests are conducted at each visit to exploratively evaluate the efficacy. Evaluate the change of score of each tools.
-UMSARS(Unified Multiple System Atrophy rating scale)
The scale comprises the following components:
Part I, historical, 12 items; Part II, motor examination, 14 items; Part III, autonomic examination; and Part IV, global disability scale (total UMSARS with scores ranging from 1 to 109)
-K-MMSE(Korea Mini-Mental Status Examination)
The scale comprises the following components:
Orientation, memory, attention and calculation, naming and language, and drawing (total K-MMSE score of 30)
-DSM-Ⅳ(Diagnostic and Statistical Manual of Mental Disorders)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start28 Aug 2018
- Primary completion25 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System AtrophyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corestemchemon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phil Hyu Lee, MD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495582
- Sponsor's protocol ID
- CS10BR05-MSA101-E
- Status last verified
- Jan 2025
- First submitted
- 21 Jul 2020
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Long-term Safety and Efficacy of Subjects Who Participated in CS10BR05 Inj. Phase 1 Study
- ClinicalTrials.gov ID
- NCT04495582
- Acronym / sponsor ID
- CS10BR05-MSA101-E
- Conditions
- Multiple System Atrophy
- Keywords
- Mesenchymal stem cell, Cell therapy, Multiple system atrophy, Neuroprotection, CS10BR05, Long-term Safety Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Corestemchemon, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 3 Aug 2020 (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.
The study purpose is conducting follow-up surveillance for the incidence of adverse events and efficacy of subjects participated in phase 1 trial to evaluate the safety and tolerability of autologous bone marrow-derived mesenchymal stem cells (CS10BR05) in subjects with Multiple System Atrophy until 60 months from administering investigational product (IP).
Detailed description
Multiple system atrophy is a neurodegenerative disease of the central nervous system which is accompanied by signs of autonomic imbalance (orthostatic hypotension, urinary problems and erectile dysfunction), Parkinson's symptoms (movement decreases and limb tremors) and cerebellar ataxia symptoms (grogginess and incorrect pronunciation). It shows signs similar to Parkinson's disease, however, it doesn't show improvement of symptoms by dopaminergic drugs and occurs at any age.
The purpose is conducting follow-up surveillance for the incidence of adverse events and efficacy of subjects participated in phase 1 trial to evaluate the safety and tolerability of autologous bone marrow-derived mesenchymal stem cells (CS10BR05) in subjects with Multiple System Atrophy until 60 months from administering investigational product (IP).
Because it is the following observational study for subjects participated in phase 1 trial, there is no additional administration of the investigational product in the study.
If the subjects who participated in phase 1 trial voluntarily consent in writing to take part in this observational study, the subjects visit the institution according to the protocol that designed the follow-up visits every 3 months (Visit 1, Visit 2) until 6 months from administration of investigational product and since then 6 months later (Visit 3), every 12 months (Visit 4~7) to observe the incidence of adverse events and efficacy.
As a result of evaluating severity of AE divided into subjective, objective in accordance with the CTCAE (Version 4.0) standards.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Interventional Study group | – | –Subjects participating in this observational study originally participated in CS10BR05 Inj. phase 1 study. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The subjects who participated in the phase 1 clinical trial(NCT03265444, Protocol No.: CS10BR05-MSA101) will be enrolled in this study, so the number of enrolled subjects will depend on the number of actual enrolled subjects for the phase 1 clinical trial.
Key inclusion criteria (2 listed)
- Subjects who participated in the phase 1 clinical trial(Protocol No.: CS10BR05- MSA101) at 3 months after administering investigational product
- Subjects who give a written, signed and dated informed consent spontaneously
Key exclusion criteria (1 listed)
- Subjects who decided as inappropriate cases to participate in the observational study by investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety assessment(evaluation)
Time frame: 5 years
1. Adverse events(AE): After the completion of the CS10BR05-MSA101 phase 1 trial, new adverse events, including tumor are assessed and detailed information is collected at each visit. Whole body PET test is performed for tumor observation at visit 7. 2. Laboratory test: The following laboratory tests are performed at each visit. * Hematology test: WBC, RBC, Hemoglobin, Hematocrit, Platelets count, WBC Diffcount * Chemistry test: Na, K, Ca, Cl, BUN, Creatinine, Uric acid, Total bilirubin, Albumin, Total protein, Creatine Kinase, Cystatin-C, ALT, AST, r-GT, ALP, LDH, Glucose, Total cholesterol, Triglyceride * Urine test: Protein, Glucose, Urobilinogen, WBC, RBC 3. Measuring vital signs (blood pressure in mmHg, heart rate in bpm, body temperature in Celsius) is performed at each visit. 4. Physical examination is performed at each visit. If clinically significant abnormal findings are recorded in the CRF and collected as AEs.
Efficacy assessment(evaluation)
Time frame: 5 years
The following tests are conducted at each visit to exploratively evaluate the efficacy. Evaluate the change of score of each tools. -UMSARS(Unified Multiple System Atrophy rating scale) The scale comprises the following components: Part I, historical, 12 items; Part II, motor examination, 14 items; Part III, autonomic examination; and Part IV, global disability scale (total UMSARS with scores ranging from 1 to 109) -K-MMSE(Korea Mini-Mental Status Examination) The scale comprises the following components: Orientation, memory, attention and calculation, naming and language, and drawing (total K-MMSE score of 30) -DSM-Ⅳ(Diagnostic and Statistical Manual of Mental Disorders)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Corestem Inc.Link provided by the sponsor.
- Severance hospital Institutional Review BoardLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Phil Hyu Lee, MD principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple System Atrophy, run by Corestemchemon, Inc. at 1 site in South Korea.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 7 Jan 2025. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment(evaluation) (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2025.