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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03265444
• Date of registration: 06/08/2017
• Prospective Registration: Yes
• Primary sponsor: Corestem, Inc.
• Public title: Safety and Tolerability of CS10BR05 Inj. in Subjects With Multiple System Atrophy
• Scientific title: A Phase 1 Study to Evaluate the Safety and Tolerability of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Subjects With Multiple System Atrophy
• Date of first enrolment: April 13, 2018
• Target sample size: 9
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03265444
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Korea, Republic of

Contacts

• Name: Phil Hyu Lee, M.D.
• Affiliation: Yonsei University

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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, HTLV?/?, 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;)

- Severe disease uncontrolled (diabetes)

- Those who are using drug likely to affect bone marrow functions

- Pregnant women or nursing women

- Women of childbearing age and male who do not consent to use proper contraception to
prevent his partner from being pregnant during participation in the study

- Now clinical trials treated with other drugs and in clinical trials the previous 4
weeks

- Subjects who by the investigator to make them ineligible for participation in this
clinical study



Age minimum: 30 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple System Atrophy

Intervention(s)

Biological: CS10BR05

Primary Outcome(s)

Adverse events, frequency and rate of vitals sign, laboratory test, physical examination, ECG, etc. [Time Frame: up to 28days]

Dose-Limiting Toxicity and Maximum Tolerated Dose of CS10BR05 Inj. [Time Frame: up to 28days]

Secondary Outcome(s)

Unified Multiple System Atrophy Rating Scale(UMSARS) [Time Frame: -35days, 28days]

Secondary ID(s)

CS10BR05-MSA101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors