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

Corestemchemon

Status and phase

Completed

Phase 1

Conditions

Multiple System Atrophy

Treatments

Biological: CS10BR05

Study type

Interventional

Funder types

Industry

Identifiers

NCT03265444

CS10BR05-MSA101

Details and patient eligibility

About

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.

Full 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 dysfunction), Parkinson's symptoms (movement decreases, limb tremors) and cerebellar ataxia symptoms (grogginess, pronounced incorrectly). 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 clinical trial was designed as a single center, open-label, public phase 1 clinical trials.

If that subject's written consent to participate in this clinical trial will be conducted the required examinations and tests in accordance with the study protocol.

Then, the register for each dose step. For the final 3 subjects in the inclusion / exclusion criteria and be administered a drug test.

And check the adverse events for more than four hours after administration of the investigational drug, and will determine whether the expression of adverse drug reaction(ADR) by the visit after 1 days, 14 days and 28 days.

Except for dose administration, all subject are tested in the same schedule. As a result of evaluating severity of AE divided into subjective, objective in accordance with the CTCAE (Version 4.0) standards.

Enrollment

9 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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, 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