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

January 5, 2025 updated by: Corestemchemon, Inc.

Observational Study of Long-term Safety and Efficacy of Subjects Who Participated in CS10BR05 Inj. Phase 1 Study

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).

Study Overview

Status

Completed

Conditions

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 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.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Korea, Republic of
- - Seoul, Korea, Republic of
    - Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The subjects who participated in the phase 1 clinical trial(NCT03265444, Protocol No.: CS10BR05-MSA101) will be enrolled in this study, so the number of enrolled subjects will depend on the number of actual enrolled subjects for the phase 1 clinical trial.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Other
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Non-Interventional Study group Subjects participating in this observational study originally participated in CS10BR05 Inj. phase 1 study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessment(evaluation) Time Frame: 5 years	Adverse events(AE): After the completion of the CS10BR05-MSA101 phase 1 trial, new adverse events, including tumor are assessed and detailed information is collected at each visit. Whole body PET test is performed for tumor observation at visit 7. Laboratory test: The following laboratory tests are performed at each visit. Hematology test: WBC, RBC, Hemoglobin, Hematocrit, Platelets count, WBC Diffcount Chemistry test: Na, K, Ca, Cl, BUN, Creatinine, Uric acid, Total bilirubin, Albumin, Total protein, Creatine Kinase, Cystatin-C, ALT, AST, r-GT, ALP, LDH, Glucose, Total cholesterol, Triglyceride Urine test: Protein, Glucose, Urobilinogen, WBC, RBC Measuring vital signs (blood pressure in mmHg, heart rate in bpm, body temperature in Celsius) is performed at each visit. Physical examination is performed at each visit. If clinically significant abnormal findings are recorded in the CRF and collected as AEs.	5 years
Efficacy assessment(evaluation) Time Frame: 5 years	The following tests are conducted at each visit to exploratively evaluate the efficacy. Evaluate the change of score of each tools. -UMSARS(Unified Multiple System Atrophy rating scale) The scale comprises the following components: Part I, historical, 12 items; Part II, motor examination, 14 items; Part III, autonomic examination; and Part IV, global disability scale (total UMSARS with scores ranging from 1 to 109) -K-MMSE(Korea Mini-Mental Status Examination) The scale comprises the following components: Orientation, memory, attention and calculation, naming and language, and drawing (total K-MMSE score of 30) -DSM-Ⅳ(Diagnostic and Statistical Manual of Mental Disorders)	5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corestemchemon, Inc.

Investigators

Principal Investigator: Phil Hyu Lee, MD, Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2018

Primary Completion (Actual)

September 25, 2024

Study Completion (Actual)

September 25, 2024

Study Registration Dates

First Submitted

July 21, 2020

First Submitted That Met QC Criteria

July 28, 2020

First Posted (Actual)

August 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 5, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CS10BR05-MSA101-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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