NCT03265444

Safety and Tolerability of CS10BR05 Inj. in Subjects with Multiple System Atrophy

A Phase 1 Study to Evaluate the Safety and Tolerability of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Subjects with Multiple System Atrophy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Corestemchemon, Inc. · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
BIOLOGICAL	CS10BR05	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.

Timeline

• Start date: 2018-04-13
• Primary completion: 2019-12-05
• Completion: 2019-12-05
• First posted: 2017-08-29
• Last updated: 2024-10-18

Locations

1 site across 1 country: South Korea