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

Multiple System Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04495582
• Other study ID #: CS10BR05-MSA101-E
• Status: Active, not recruiting
• Start date: August 28, 2018
• Est. completion date: November 2024

Study information

• Verified date: August 2023
• Source: Corestemchemon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Multiple System Atrophy
• Shy-Drager Syndrome

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Corestemchemon, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessment(evaluation)	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
Primary	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-?(Diagnostic and Statistical Manual of Mental Disorders)	5 years

External Links

•   Corestem Inc.
•   Severance hospital Institutional Review Board