Long-term Follow-up of Phase 1 Clinical Trial of CS10BR05(CS10BR05-MSA101)

NCT ID: NCT04495582

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-28
• Study Completion Date: 2024-09-25

Brief Summary

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).

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 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.

Conditions

Multiple System Atrophy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-Interventional Study group

Subjects participating in this observational study originally participated in CS10BR05 Inj. phase 1 study.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Subjects who participated in the phase 1 clinical trial(Protocol No.: CS10BR05- MSA101) at 3 months after administering investigational product
• Subjects who give a written, signed and dated informed consent spontaneously

Exclusion Criteria

• Subjects who decided as inappropriate cases to participate in the observational study by investigator

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corestemchemon, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Phil Hyu Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

Yonsei University College of Medicine

Seoul, , South Korea

Countries

South Korea

Related Links

http://corestem.com/

Corestem Inc.

http://mdctc.yuhs.ac/HPC/Sinchon/IRB/IrbIntro

Severance hospital Institutional Review Board

Other Identifiers

CS10BR05-MSA101-E

Identifier Type: -

Identifier Source: org_study_id