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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Interventional Study group | Subjects participating in this observational study originally participated in CS10BR05 Inj. phase 1 study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment(evaluation) |
| 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-â…£(Diagnostic and Statistical Manual of Mental Disorders) | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Phil Hyu Lee, MD | Yonsei University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University College of Medicine | Seoul | South Korea |
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| Label | URL |
|---|---|
| Corestem Inc. | View source |
| Severance hospital Institutional Review Board | View source |
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| ID | Term |
|---|---|
| D019578 | Multiple System Atrophy |
| ID | Term |
|---|---|
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001480 | Basal Ganglia Diseases |
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| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |