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

Primary Purpose

Multiple System Atrophy

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CS10BR05
Sponsored by
Corestemchemon, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple System Atrophy focused on measuring MSA

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CS10BR05

Arm Description

The single injection of CS10BR05 Inj. in the carotid artery

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Unified Multiple System Atrophy Rating Scale(UMSARS)
Part I (Historical review), part II (Motor examination scale), part III (Autonomic examination), part IV (Global disability scale) assessment

Full Information

First Posted
August 6, 2017
Last Updated
August 6, 2020
Sponsor
Corestemchemon, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03265444
Brief Title
Safety and Tolerability of CS10BR05 Inj. in Subjects With Multiple System Atrophy
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 13, 2018 (Actual)
Primary Completion Date
December 5, 2019 (Actual)
Study Completion Date
December 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corestemchemon, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple System Atrophy
Keywords
MSA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CS10BR05
Arm Type
Experimental
Arm Description
The single injection of CS10BR05 Inj. in the carotid artery
Intervention Type
Biological
Intervention Name(s)
CS10BR05
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dose-Limiting Toxicity and Maximum Tolerated Dose of CS10BR05 Inj.
Description
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).
Time Frame
up to 28days
Title
Adverse events, frequency and rate of vitals sign, laboratory test, physical examination, ECG, etc.
Description
To evaluate the safety and tolerability of CS10BR05 Inj. in patients with Multiple System Atrophy.
Time Frame
up to 28days
Secondary Outcome Measure Information:
Title
Unified Multiple System Atrophy Rating Scale(UMSARS)
Description
Part I (Historical review), part II (Motor examination scale), part III (Autonomic examination), part IV (Global disability scale) assessment
Time Frame
-35days, 28days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phil Hyu Lee, M.D.
Organizational Affiliation
Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.corestem.com
Description
Corestem Inc.

Learn more about this trial

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

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