Safety and Tolerability of CS10BR05 Inj. in Subjects With Multiple System Atrophy
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|ClinicalTrials.gov Identifier: NCT03265444|
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : April 19, 2018
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)|
|Estimated 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|
|Estimated Primary Completion Date :||June 30, 2018|
|Estimated Study Completion Date :||December 31, 2018|
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.
- Adverse event rate [ Time Frame: up to 28days ]Adverse event assessed by CTCAE v4.03
- Safety [ Time Frame: up to 28days ]Frequency and rate of vitals sign, laboratory test, physical examination, ECG
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265444
|Contact: Ji-min Kimemail@example.com|
|Korea, Republic of|
|Yonsei University College of Medicine||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Phil Hyu Lee, M.D. +82 02 2228 1600 firstname.lastname@example.org|
|Principal Investigator:||Phil Hyu Lee, M.D.||Yonsei University|