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

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ClinicalTrials.gov Identifier: NCT03265444
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Corestem, Inc.

August 6, 2017
August 29, 2017
April 19, 2018
April 13, 2018
June 30, 2018   (Final data collection date for primary outcome measure)
  • Adverse event rate [ Time Frame: up to 28days ]
    Adverse event assessed by CTCAE v4.03
  • Safety [ Time Frame: up to 28days ]
    Frequency and rate of vitals sign, laboratory test, physical examination, ECG
  • Adverse event rate [ Time Frame: up to 28days ]
    Adverse event assessed by CTCAE v4.03
  • Safety assessment(evaluation) [ Time Frame: up to 28days ]
    Frequency and rate of vitals sign, laboratory test, physical examination, ECG
Complete list of historical versions of study NCT03265444 on ClinicalTrials.gov Archive Site
Unified Multiple System Atrophy Rating Scale(UMSARS) [ Time Frame: -35days, 28days ]
Part I (Historical review), part II (Motor examination scale), part III (Autonomic examination), part IV (Global disability scale) assessment
Same as current
Not Provided
Not Provided
 
Safety and Tolerability of CS10BR05 Inj. in Subjects With Multiple System Atrophy
A Phase 1 Study to Evaluate the Safety and Tolerability of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Subjects With Multiple System Atrophy

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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple System Atrophy
Biological: CS10BR05
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.
Experimental: CS10BR05
The single injection of CS10BR05 Inj. in the carotid artery
Intervention: Biological: CS10BR05
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
9
Same as current
December 31, 2018
June 30, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 75 Years   (Adult, Older Adult)
No
Contact: Ji-min Kim +82-70-4707-3545 jmkim@corestem.com
Korea, Republic of
 
 
NCT03265444
CS10BR05-MSA101
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Corestem, Inc.
Corestem, Inc.
Not Provided
Principal Investigator: Phil Hyu Lee, M.D. Yonsei University
Corestem, Inc.
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP