Multiple System AtrophyPhase 1NCT03265444
Safety and Tolerability of CS10BR05 Inj. in Subjects with Multiple System Atrophy
A Phase 1 study testing CS10BR05 in people with Multiple System Atrophy, run by Corestemchemon, Inc. at 1 site in South Korea.
Trial summary
The purpose of conducting phase 1 trial is to evaluate the safety and tolerability of autologous bone marrow-derived mesenchymal stem cells(CS10BR05) in subjects with Multiple System Atrophy. Evaluation of DLT by carotid artery(intra-arterial) injection according to dose-escalating in Multiple System Atrophy. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Multiple System Atrophy
- What is being tested?
- CS10BR05
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Apr 2018to 5 Dec 2019
- Phase
- Phase 1
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female patients aged ≥30 years and ≤ 75 years
- Meet criteria for diagnosis of probable MSA -cerebellar type according to the Gilman Criteria(2008)
- MRI or PET imaging showed a decrease in the cerebellar atrophy or cerebral metabolism
- Patients who are less than 4 years from the time of documented MSA diagnosis
- Patients unified MSA rating scale 30~50
- Those who have no hematologic abnormalities and who are not suspected of failing bone marrow function
- Patients who consented to participate in the study in writing by themselves or their legal representatives
Who cannot join
- Suspected clear Dementia (K-MMSE < 24)
- DSM-IV criteria for Dementia
- Radiologic imaging findings suggest that vascular encephalopathy coexist
- Other central nervous system diseases except MSA (Parkinsons disease etc.)
- Patients with Stroke or Brain surgery
- If there is a coexistence of severe medical illness, or if it is in a severe pyrexia state
Show all 21Show fewer
- Serum SGOT / SGPT measures above three times of upper limit of normal or creatine levels were above 1.5 times of upper limit of normal levels were more than 1.5 times normal
- disease that affects the patient's long-term survival(Tumor, Serious Heart failure)
- Patients with genetic tests showed that spinocerebellar ataxia 1, 2, 3, 6, 7, 17
- Patients with unstable vital signs
- Patients with uncontrolled comorbidities such as moderate to severe infections, bleeding
- Those who are found to be active to viral infection(HBV, HCV, HIV, CMV, HTLVⅠ/Ⅱ, VDRL)
- Patients who are hypersensitive to bovine protein or antibiotics such as penicillin and streptomycin
- Patients with difficult catheter insertion(bleeding disorder, artery hardening narrowness, Patients who are at risk of stroke in cerebral angiography)
- Patients with cardiovascular disease(for example, hypertension, myocardial infarction etc;)
- Severe disease uncontrolled (diabetes)
- Those who are using drug likely to affect bone marrow functions
- Pregnant women or nursing women
- Women of childbearing age and male who do not consent to use proper contraception to prevent his partner from being pregnant during participation in the study
- Now clinical trials treated with other drugs and in clinical trials the previous 4 weeks
- Subjects who by the investigator to make them ineligible for participation in this clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Evaluate the Safety and Tolerability of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Subjects with Multiple System Atrophy
The purpose of conducting phase 1 trial is to evaluate the safety and tolerability of autologous bone marrow-derived mesenchymal stem cells(CS10BR05) in subjects with Multiple System Atrophy.
Evaluation of DLT by carotid artery(intra-arterial) injection according to dose-escalating in Multiple System Atrophy.
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, erectile dysfunction), Parkinson's symptoms (movement decreases, limb tremors) and cerebellar ataxia symptoms (grogginess, pronounced incorrectly). 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 clinical trial was designed as a single center, open-label, public phase 1 clinical trials.
If that subject's written consent to participate in this clinical trial will be conducted the required examinations and tests in accordance with the study protocol.
Then, the register for each dose step. For the final 3 subjects in the inclusion / exclusion criteria and be administered a drug test.
And check the adverse events for more than four hours after administration of the investigational drug, and will determine whether the expression of adverse drug reaction(ADR) by the visit after 1 days, 14 days and 28 days.
Except for dose administration, all subject are tested in the same schedule. 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
- Being tested
- CS10BR05
- Keywords
- MSA
- 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.
CS10BR05Biological
The single injection of CS10BR05 Inj. in the carotid artery; Step 1 dose : 3.0x105cells/kg; Step 2 dose : 6.0x105cells/kg; Step 3 dose : 9.0x105cells/kg; The duration of follow up study following the single dose of CS10BR05 is 28 days.
| Study group | Role | What they receive |
|---|---|---|
| CS10BR05 | Experimental | The single injection of CS10BR05 Inj. in the carotid artery Receives: Biological: CS10BR05 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity and Maximum Tolerated Dose of CS10BR05 Inj.
To evaluate the safety and tolerability of CS10BR05 Inj. in patients with Multiple System Atrophy including determination of its Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD).
Measured: up to 28days
Adverse events, frequency and rate of vitals sign, laboratory test, physical examination, ECG, etc.
To evaluate the safety and tolerability of CS10BR05 Inj. in patients with Multiple System Atrophy.
Measured: up to 28days
Secondary outcomes (1)
Unified Multiple System Atrophy Rating Scale(UMSARS)
Part I (Historical review), part II (Motor examination scale), part III (Autonomic examination), part IV (Global disability scale) assessment
Measured: -35days, 28days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start13 Apr 2018
- Primary completion5 Dec 2019
- Study completion5 Dec 2019
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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corestemchemon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phil Hyu Lee, M.D., Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265444
- Sponsor's protocol ID
- CS10BR05-MSA101
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2017
- Last updated
- 18 Oct 2024
- 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 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety and Tolerability of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Subjects with Multiple System Atrophy
- ClinicalTrials.gov ID
- NCT03265444
- Acronym / sponsor ID
- CS10BR05-MSA101
- Conditions
- Multiple System Atrophy
- Keywords
- MSA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Corestemchemon, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 29 Aug 2017 (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 purpose of conducting phase 1 trial is to evaluate the safety and tolerability of autologous bone marrow-derived mesenchymal stem cells(CS10BR05) in subjects with Multiple System Atrophy.
Evaluation of DLT by carotid artery(intra-arterial) injection according to dose-escalating in Multiple System Atrophy.
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, erectile dysfunction), Parkinson's symptoms (movement decreases, limb tremors) and cerebellar ataxia symptoms (grogginess, pronounced incorrectly). 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 clinical trial was designed as a single center, open-label, public phase 1 clinical trials.
If that subject's written consent to participate in this clinical trial will be conducted the required examinations and tests in accordance with the study protocol.
Then, the register for each dose step. For the final 3 subjects in the inclusion / exclusion criteria and be administered a drug test.
And check the adverse events for more than four hours after administration of the investigational drug, and will determine whether the expression of adverse drug reaction(ADR) by the visit after 1 days, 14 days and 28 days.
Except for dose administration, all subject are tested in the same schedule. As a result of evaluating severity of AE divided into subjective, objective in accordance with the CTCAE (Version 4.0) standards.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CS10BR05 | Experimental | Biological: CS10BR05The single injection of CS10BR05 Inj. in the carotid artery |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and Female patients aged ≥30 years and ≤ 75 years
- Meet criteria for diagnosis of probable MSA -cerebellar type according to the Gilman Criteria(2008)
- MRI or PET imaging showed a decrease in the cerebellar atrophy or cerebral metabolism
- Patients who are less than 4 years from the time of documented MSA diagnosis
- Patients unified MSA rating scale 30~50
Key exclusion criteria (21 listed)
- Suspected clear Dementia (K-MMSE < 24)
- DSM-IV criteria for Dementia
- Radiologic imaging findings suggest that vascular encephalopathy coexist
- Other central nervous system diseases except MSA (Parkinsons disease etc.)
- Patients with Stroke or Brain surgery
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 |
|---|---|---|
| CS10BR05The single injection of CS10BR05 Inj. in the carotid artery; Step 1 dose : 3.0x105cells/kg; Step 2 dose : 6.0x105cells/kg; Step 3 dose : 9.0x105cells/kg; The duration of follow up study following the single dose of CS10BR05 is 28 days. | Biological | CS10BR05 |
Primary outcome
Dose-Limiting Toxicity and Maximum Tolerated Dose of CS10BR05 Inj.
Time frame: up to 28days
To evaluate the safety and tolerability of CS10BR05 Inj. in patients with Multiple System Atrophy including determination of its Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD).
Adverse events, frequency and rate of vitals sign, laboratory test, physical examination, ECG, etc.
Time frame: up to 28days
To evaluate the safety and tolerability of CS10BR05 Inj. in patients with Multiple System Atrophy.
1 secondary outcome
Unified Multiple System Atrophy Rating Scale(UMSARS)
Time frame: -35days, 28days
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 18 Oct 2024.
- Corestem Inc.Link 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, M.D. 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?
A Phase 1 study testing CS10BR05 in people with 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 7 inclusion and 21 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 18 Oct 2024. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Dose-Limiting Toxicity and Maximum Tolerated Dose of CS10BR05 Inj. (time frame: up to 28days). 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 18 Oct 2024.