Safety and Tolerability of CS10BR05 Inj. in Subjects With Multiple System Atrophy
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|ClinicalTrials.gov Identifier: NCT03265444|
Recruitment Status : Completed
First Posted : August 29, 2017
Last Update Posted : August 7, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple System Atrophy||Biological: CS10BR05||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||April 13, 2018|
|Actual Primary Completion Date :||December 5, 2019|
|Actual Study Completion Date :||December 5, 2019|
The single injection of CS10BR05 Inj. in the carotid artery
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.
- 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.
- Unified Multiple System Atrophy Rating Scale(UMSARS) [ Time Frame: -35days, 28days ]Part I (Historical review), part II (Motor examination scale), part III (Autonomic examination), part IV (Global disability scale) assessment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265444
|Korea, Republic of|
|Yonsei University College of Medicine|
|Seoul, Korea, Republic of|
|Principal Investigator:||Phil Hyu Lee, M.D.||Yonsei University|