Status:
COMPLETED
Safety and Tolerability of CS10BR05 Inj. in Subjects with Multiple System Atrophy
Lead Sponsor:
Corestemchemon, Inc.
Conditions:
Multiple System Atrophy
Eligibility:
All Genders
30-75 years
Phase:
PHASE1
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. Evaluat...
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, erectile dysfuncti...
Eligibility Criteria
Inclusion
- 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
- 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;)
- 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
Key Trial Info
Start Date :
April 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2019
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03265444
Start Date
April 13 2018
End Date
December 5 2019
Last Update
October 18 2024
Active Locations (1)
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1
Yonsei University College of Medicine
Seoul, South Korea