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

NCT04495582 | Completed DMC

• 1 other identifier: CS10BR05-MSA101-E
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple System Atrophy

Keywords

Mesenchymal stem cell; Cell therapy; Multiple system atrophy; Neuroprotection; CS10BR05; Long-term Safety Study

Outcome Measures

Primary Outcomes (2)

• Safety assessment(evaluation)

  1. 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. 2. 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 3. Measuring vital signs (blood pressure in mmHg, heart rate in bpm, body temperature in Celsius) is performed at each visit. 4. 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)

  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

Study Arms (1)

Non-Interventional Study group

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

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Corestemchemon, Inc.: lead

Study Sites (1)

Yonsei University College of Medicine

Seoul, South Korea

Location

Related Links

• Corestem Inc.
• Severance hospital Institutional Review Board

MeSH Terms

Conditions

Multiple System Atrophy

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Phil Hyu Lee, MD

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: August 3, 2020
• Study Start: August 28, 2018
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)