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

NCT03265444 | Completed Phase 1 DMC

• 1 other identifier: CS10BR05-MSA101
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple System Atrophy

Keywords

MSA

Outcome Measures

Primary Outcomes (2)

• Dose-Limiting Toxicity and Maximum Tolerated Dose of CS10BR05 Inj.

  To evaluate the safety and tolerability of CS10BR05 Inj. in patients with Multiple System Atrophy including determination of its Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD).

  up to 28days

• Adverse events, frequency and rate of vitals sign, laboratory test, physical examination, ECG, etc.

  To evaluate the safety and tolerability of CS10BR05 Inj. in patients with Multiple System Atrophy.

  up to 28days

Secondary Outcomes (1)

• Unified Multiple System Atrophy Rating Scale(UMSARS)

  -35days, 28days

Study Arms (1)

CS10BR05

EXPERIMENTAL

The single injection of CS10BR05 Inj. in the carotid artery

Biological: CS10BR05

Interventions

CS10BR05 BIOLOGICAL

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.

CS10BR05

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female patients aged ≥30 years and ≤ 75 years
• Meet criteria for diagnosis of probable MSA -cerebellar type according to the Gilman Criteria(2008)
• MRI or PET imaging showed a decrease in the cerebellar atrophy or cerebral metabolism
• Patients who are less than 4 years from the time of documented MSA diagnosis
• Patients unified MSA rating scale 30\~50
• Those who have no hematologic abnormalities and who are not suspected of failing bone marrow function
• Patients who consented to participate in the study in writing by themselves or their legal representatives

You may not qualify if:

• Suspected clear Dementia (K-MMSE \< 24)
• DSM-IV criteria for Dementia
• Radiologic imaging findings suggest that vascular encephalopathy coexist
• Other central nervous system diseases except MSA (Parkinsons disease etc.)
• Patients with Stroke or Brain surgery
• If there is a coexistence of severe medical illness, or if it is in a severe pyrexia state
• Serum SGOT / SGPT measures above three times of upper limit of normal or creatine levels were above 1.5 times of upper limit of normal levels were more than 1.5 times normal
• disease that affects the patient's long-term survival(Tumor, Serious Heart failure)
• Patients with genetic tests showed that spinocerebellar ataxia 1, 2, 3, 6, 7, 17
• Patients with unstable vital signs
• Patients with uncontrolled comorbidities such as moderate to severe infections, bleeding
• Those who are found to be active to viral infection(HBV, HCV, HIV, CMV, HTLVⅠ/Ⅱ, VDRL)
• Patients who are hypersensitive to bovine protein or antibiotics such as penicillin and streptomycin
• Patients with difficult catheter insertion(bleeding disorder, artery hardening narrowness, Patients who are at risk of stroke in cerebral angiography)
• Patients with cardiovascular disease(for example, hypertension, myocardial infarction etc;)

Sponsors & Collaborators

• Corestemchemon, Inc.: lead

Study Sites (1)

Yonsei University College of Medicine

Seoul, South Korea

Location

Related Links

• Corestem Inc.

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, M.D.

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2017
• First Posted: August 29, 2017
• Study Start: April 13, 2018
• Primary Completion: December 5, 2019
• Study Completion: December 5, 2019
• Last Updated: October 18, 2024

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)