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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CS10BR05 | Experimental | The single injection of CS10BR05 Inj. in the carotid artery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS10BR05 | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | up to 28days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | -35days, 28days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phil Hyu Lee, M.D. | 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 |
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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 |