Clinical Trials List
Protocol NumberES-CMSC01-B1101
2020-04-01 - 2025-12-31
Phase I
Recruiting2
ICD-10I63.50
Cerebral infarction due to unspecified occlusion or stenosis of unspecified cerebral artery
ICD-10I63.511
Cerebral infarction due to unspecified occlusion or stenosis of right middle cerebral artery
ICD-10I63.512
Cerebral infarction due to unspecified occlusion or stenosis of left middle cerebral artery
ICD-10I63.519
Cerebral infarction due to unspecified occlusion or stenosis of unspecified middle cerebral artery
ICD-10I63.521
Cerebral infarction due to unspecified occlusion or stenosis of right anterior cerebral artery
ICD-10I63.522
Cerebral infarction due to unspecified occlusion or stenosis of left anterior cerebral artery
ICD-10I63.529
Cerebral infarction due to unspecified occlusion or stenosis of unspecified anterior cerebral artery
ICD-10I63.531
Cerebral infarction due to unspecified occlusion or stenosis of right posterior cerebral artery
ICD-10I63.532
Cerebral infarction due to unspecified occlusion or stenosis of left posterior cerebral artery
ICD-10I63.539
Cerebral infarction due to unspecified occlusion or stenosis of unspecified posterior cerebral artery
ICD-10I63.541
Cerebral infarction due to unspecified occlusion or stenosis of right cerebellar artery
ICD-10I63.542
Cerebral infarction due to unspecified occlusion or stenosis of left cerebellar artery
ICD-10I63.549
Cerebral infarction due to unspecified occlusion or stenosis of unspecified cerebellar artery
ICD-10I63.59
Cerebral infarction due to unspecified occlusion or stenosis of other cerebral artery
ICD-10I63.8
Other cerebral infarction
ICD-10I63.9
Cerebral infarction, unspecified
ICD-9434.91
Unspecified cerebral artery occlusion with cerebral infarction
A phase I, open label study to evaluate the safety and to explore the efficacy of allogeneic umbilical cord mesenchymal stem cells in patients with acute ischemic stroke
-
Trial Applicant
EVER SUPREME BIO TECHNOLOGY CO., LTD.
-
Sponsor
Ever Supreme Bio Technology
-
Trial scale
Taiwan Single Center
-
Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Kang-Hsu Lin Division of Neurology
- Wei-Chung Wang Division of Neurology
- Yi-Ting Hsu Division of Neurology
- Yuh-Cherng Guo Division of Neurology
- Chung-Hsiang Liu Division of Neurology
- Sheng-Ta Tsai Division of Neurology
- Ming-Kuei Lu Division of Neurology
- 陳威良 Division of Radiology
- Ming Ho Division of Obstetrics & Gynecology
- Fu-Yu Lin Division of Neurology
- Yu Ao Division of Neurology
- Ching-Hua Lu Lu Division of Neurology
- Wei-Shih Huang Division of Neurology
- Hung-Yu Huang Division of Neurology
- Kuan-Fei Chen Division of Neurology
- Yi-Chien Yang Division of Neurology
- 曾盈霖 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
acute ischemic stroke
Objectives
Primary Objective
To evaluate the safety of UMSC01 administered by IV delivery in
patients with acute ischemic stroke, and sequentially by IV
delivery followed by IA infusion in patients with acute ischemic
stroke with or without bridging therapy (i.e. Intravenous rt-PA
thrombolysis or intraarterial thrombectomy)
Secondary Objective
To explore the efficacy and safety of UMSC01 administered by
IV in patients with acute ischemic stroke, and sequentially by IV
delivery followed by IA infusion in patients with acute ischemic
stroke with or without bridging therapy (i.e. IV rt-PA thrombolysis
or IA thrombectomy).
Test Drug
UMSC01
Active Ingredient
Allogeneic umbilical cord mesenchymal stem cells
Dosage Form
IV, IA
Dosage
IV: 1*10^8/ 8*10^7, IA:1*10^7/ 2*10^7
Endpoints
Primary Endpoint
The primary endpoint will be safety evaluations including:
➢ SAE, SUSAR, and TEAE incidences over the study period
Secondary Endpoints
Efficacy
1. Glasgow Coma Scale (GCS)
2. National Institutes of Health Stroke Scale (NIHSS)
3. modified Rankin Scale (mRS)
4. Fugl-Meyer Test (FMT)
5. Barthel Index (BI)
6. MRI results
7. Brain SPECT perfusion results
Safety
1. Laboratory data changes
2. Changes in physical examinations
3. Changes in vital signs
The primary endpoint will be safety evaluations including:
➢ SAE, SUSAR, and TEAE incidences over the study period
Secondary Endpoints
Efficacy
1. Glasgow Coma Scale (GCS)
2. National Institutes of Health Stroke Scale (NIHSS)
3. modified Rankin Scale (mRS)
4. Fugl-Meyer Test (FMT)
5. Barthel Index (BI)
6. MRI results
7. Brain SPECT perfusion results
Safety
1. Laboratory data changes
2. Changes in physical examinations
3. Changes in vital signs
Inclution Criteria
Inclusion Criteria for Donor:
1. Pregnant women who are aged ≥ 20, <50 years old on the
date of consent.
2. Pregnant women who are willing to and has given her
signed written informed consent.
3. Pregnant women whose gestation age ≥ 34 weeks and have
intact placenta.
4. Pregnant women who have not had any complication of pregnancy.
5. Pregnant women who are willing to provide a personal and
family medical history (as much available) of herself and the
biologic father (as much available), prior to or following
collection of the umbilical cord.
Diagnosis and Main Inclusion Criteria for Study Patients:
1. Male or female who are age ≥ 20, ≤80 years old on date of
consent.
2. Patients who have had a recent (onset within the past 36
hours) acute ischemic stroke in the unilateral middle cerebral
artery (MCA) distribution (M1 and M2). The location of
ischemic stroke should be diagnosed by magnetic resonance image (MRI).
3. Patients who have National Institutes of Health Stroke Scale
(NIHSS) score of 7 to 16 with both motor arm and motor leg
scores ≥ 3 (MRC scale).
4. Patients who have Glasgow Coma Scale (GCS) score of > 8 on
the date of consent.
5. Patients who have modified Rankin Scale (mRS) of 2~4 on the
date of consent and their mRS prior to stroke onset should be 0
or 1 (either by self-reported history or by family/caregiver
report).
6. Patients who have stable vital signs for at least 24 hours, defined
as normal respiration, afebrile and mean arterial pressure ≤ 180
mmHg.
7. Patient’s random blood sugar <350 mg/dl and > 50 mg/dl and
normal urea/ electrolytes.
8. Patients are willing to sign informed consent or assent by the
next of kin.
9. All male patients and female patients with child-bearing
potential (between puberty and 2 years after menopause) should
use appropriate contraception method(s) shown below, for at
least 4 weeks after UMSC01 treatment.
a. Total abstinence (when this is in line with the preferred
and usual lifestyle of the subject. Periodic abstinence (e.g.,
calendar, ovulation, symptothermal, post-ovulation
methods) and withdrawal are not acceptable methods of
contraception).
b. Female sterilization (have had surgical bilateral
oophorectomy with or without hysterectomy) or tubal
ligation at least six weeks before taking study treatment.
In case of oophorectomy alone, only when the
reproductive status of the woman has been confirmed by
follow up hormone level assessment.
c. Male sterilization (at least 6 months prior to screening).
For female subjects on the study, the vasectomized male partner should be the sole partner for that subject.
d. Combination of any two of the following listed
methods: (d.1+d.2 or d.1+d.3, or d.2+d.3):
d.1 Use of oral, injected or implanted hormonal methods
of contraception or other forms of hormonal
contraception that have comparable efficacy (failure
rate <1%), for example hormone vaginal ring or
transdermal hormone contraception.
d.2 Placement of an intrauterine device (IUD)
or intrauterine system (IUS).
d.3 Barrier methods of contraception: Condom or
Occlusive cap (diaphragm or cervical/vault caps)
with Spermicidal foam/gel/film/cream/vaginal
suppository
1. Pregnant women who are aged ≥ 20, <50 years old on the
date of consent.
2. Pregnant women who are willing to and has given her
signed written informed consent.
3. Pregnant women whose gestation age ≥ 34 weeks and have
intact placenta.
4. Pregnant women who have not had any complication of pregnancy.
5. Pregnant women who are willing to provide a personal and
family medical history (as much available) of herself and the
biologic father (as much available), prior to or following
collection of the umbilical cord.
Diagnosis and Main Inclusion Criteria for Study Patients:
1. Male or female who are age ≥ 20, ≤80 years old on date of
consent.
2. Patients who have had a recent (onset within the past 36
hours) acute ischemic stroke in the unilateral middle cerebral
artery (MCA) distribution (M1 and M2). The location of
ischemic stroke should be diagnosed by magnetic resonance image (MRI).
3. Patients who have National Institutes of Health Stroke Scale
(NIHSS) score of 7 to 16 with both motor arm and motor leg
scores ≥ 3 (MRC scale).
4. Patients who have Glasgow Coma Scale (GCS) score of > 8 on
the date of consent.
5. Patients who have modified Rankin Scale (mRS) of 2~4 on the
date of consent and their mRS prior to stroke onset should be 0
or 1 (either by self-reported history or by family/caregiver
report).
6. Patients who have stable vital signs for at least 24 hours, defined
as normal respiration, afebrile and mean arterial pressure ≤ 180
mmHg.
7. Patient’s random blood sugar <350 mg/dl and > 50 mg/dl and
normal urea/ electrolytes.
8. Patients are willing to sign informed consent or assent by the
next of kin.
9. All male patients and female patients with child-bearing
potential (between puberty and 2 years after menopause) should
use appropriate contraception method(s) shown below, for at
least 4 weeks after UMSC01 treatment.
a. Total abstinence (when this is in line with the preferred
and usual lifestyle of the subject. Periodic abstinence (e.g.,
calendar, ovulation, symptothermal, post-ovulation
methods) and withdrawal are not acceptable methods of
contraception).
b. Female sterilization (have had surgical bilateral
oophorectomy with or without hysterectomy) or tubal
ligation at least six weeks before taking study treatment.
In case of oophorectomy alone, only when the
reproductive status of the woman has been confirmed by
follow up hormone level assessment.
c. Male sterilization (at least 6 months prior to screening).
For female subjects on the study, the vasectomized male partner should be the sole partner for that subject.
d. Combination of any two of the following listed
methods: (d.1+d.2 or d.1+d.3, or d.2+d.3):
d.1 Use of oral, injected or implanted hormonal methods
of contraception or other forms of hormonal
contraception that have comparable efficacy (failure
rate <1%), for example hormone vaginal ring or
transdermal hormone contraception.
d.2 Placement of an intrauterine device (IUD)
or intrauterine system (IUS).
d.3 Barrier methods of contraception: Condom or
Occlusive cap (diaphragm or cervical/vault caps)
with Spermicidal foam/gel/film/cream/vaginal
suppository
Exclusion Criteria
Exclusion Criteria for Donor:
1. Pregnant women who have clinically severe and/or lifethreatening disease(s) such as uncontrolled diabetes mellitus
(fasting sugar level > 250 mg/dL) and malignant tumor.
2. Pregnant women who have been tested positive for the
following tests within 7 days before or after umbilical cord
acquirement:
➢ Human immunodeficiency virus-1 (HIV-I): antiHIV-I and nucleic acid test (NAT)
➢ HIV-II
➢ Hepatitis B virus (HBV): Hepatitis B surface
antigen (HBsAg), anti- Hepatitis B core (HBc)
and NAT
➢ Hepatitis C virus (HCV): anti-HCV and NAT
➢ Cytomegalovirus (CMV)
➢ Treponema pallidum
➢ Chlamydia trachomatis
➢ Neisseria gonorrhea
➢ Human T cell leukemia virus-I/II (HTLV-I/II)
➢ West Nile virus (WNV) NAT
3. Pregnant women are with increased risk for CreutzfeldtJakob disease (CJD) if you have received a non-synthetic
dura mater transplant, human pituitary-derived growth
hormone, or have one or more blood relatives diagnosed with
CJD.
4. Pregnant women had spent three months or more
cumulatively in the United Kingdom (U.K) from the
beginning of 1980 through the end of 1996; or had received
any transfusion of blood or blood components in the U.K. or
France between 1980 and the present; or lived 5 years or
more cumulatively in Europe.
5. Pregnant women or her sexual partners were born or lived
in certain countries in Africa (Cameroon, Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger, or
Nigeria) after 1977 (risk factor for HIV group O).
6. Pregnant women who have medical diagnosis of Zika virus
(ZIKV) infection or residence in, or travel to, an area with
active ZIKV transmission (according to the list from Centers
for Disease Control and Prevention. Zika Virus: Areas with
Zika) at any point during that pregnancy.
7. Pregnant women who have sex at any point during that
pregnancy with a male who is known to medical diagnosis of
ZIKV infection or residence in, or travel to, an area with
active ZIKV transmission.
8. Pregnant women who have received blood infusion or stayed
for more than 3 months in WNV potential countries.
9. Pregnant women who have unexplained post-donation
febrile illness with headache or other symptoms suggestive
of WNV infection (i.e., flu-like symptoms that include fever
with headache, eye pain, body aches, generalized weakness,
new skin rash or swollen lymph nodes or other evidence of
WNV infection) within two weeks.
10. Pregnant women who have medical history of tuberculosis.
11. Pregnant women who have medical history of malignant
tumor.
12. Fetuses that have found with genetic disease in prenatal
checkups.
13. Pregnant women who would like to store cord blood or
umbilical cord cells, other than this study usage.
14. Pregnant women who are not suitable to donate as judged by
the Investigator(s).
Exclusion Criteria for Study Patients:
1. Patients with recurring stroke attack within 6 months before
this current stroke episode.
2. Patients with signs of midline shift, hemorrhagic
transformation or fluctuation of symptoms.
3. Patients who have participated in other investigational
studies and received any treatment within 4 weeks prior to
receiving UMSC01.
4. Patients who have immuno-compromised condition, or are
with known clinically significantly autoimmune conditions
or are receiving immunosuppressive treatments.
5. Patients who are unable to undergo brain Single-photo
Emission Computed Tomography (SPECT), MRI and PET
scans for any reason.
6. Patients with inadequate hepatic and renal function after
onset of acute ischemic stroke: Aspartate aminotransferase
(AST) and Alanine aminotransferase (ALT) ≥ 5 x upper limit
of normal (ULN); estimated glomerular filtration rate (eGFR)
< 30 mL/min at screening.
7. Patients who have medical history of malignant tumor, spinal
injury or other clinically significant neurological diseases that will confound the evaluation of this study.
8. Patients who have clinically active peripheral neuropathy,
myopathy or other clinically significant neurological
diseases that will confound the evaluation of this study.
9. Patients who have a difference in NIHSS score ≥ 5 between
the time beginning hospitalization and investigational
product (IP) treatment.
10. Patients who are diagnosed of heart failure with a New York
Heart Association (NYHA) score of III or IV.
11. Patients not suitable to participate the trial as judged by the
investigator(s).
1. Pregnant women who have clinically severe and/or lifethreatening disease(s) such as uncontrolled diabetes mellitus
(fasting sugar level > 250 mg/dL) and malignant tumor.
2. Pregnant women who have been tested positive for the
following tests within 7 days before or after umbilical cord
acquirement:
➢ Human immunodeficiency virus-1 (HIV-I): antiHIV-I and nucleic acid test (NAT)
➢ HIV-II
➢ Hepatitis B virus (HBV): Hepatitis B surface
antigen (HBsAg), anti- Hepatitis B core (HBc)
and NAT
➢ Hepatitis C virus (HCV): anti-HCV and NAT
➢ Cytomegalovirus (CMV)
➢ Treponema pallidum
➢ Chlamydia trachomatis
➢ Neisseria gonorrhea
➢ Human T cell leukemia virus-I/II (HTLV-I/II)
➢ West Nile virus (WNV) NAT
3. Pregnant women are with increased risk for CreutzfeldtJakob disease (CJD) if you have received a non-synthetic
dura mater transplant, human pituitary-derived growth
hormone, or have one or more blood relatives diagnosed with
CJD.
4. Pregnant women had spent three months or more
cumulatively in the United Kingdom (U.K) from the
beginning of 1980 through the end of 1996; or had received
any transfusion of blood or blood components in the U.K. or
France between 1980 and the present; or lived 5 years or
more cumulatively in Europe.
5. Pregnant women or her sexual partners were born or lived
in certain countries in Africa (Cameroon, Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger, or
Nigeria) after 1977 (risk factor for HIV group O).
6. Pregnant women who have medical diagnosis of Zika virus
(ZIKV) infection or residence in, or travel to, an area with
active ZIKV transmission (according to the list from Centers
for Disease Control and Prevention. Zika Virus: Areas with
Zika) at any point during that pregnancy.
7. Pregnant women who have sex at any point during that
pregnancy with a male who is known to medical diagnosis of
ZIKV infection or residence in, or travel to, an area with
active ZIKV transmission.
8. Pregnant women who have received blood infusion or stayed
for more than 3 months in WNV potential countries.
9. Pregnant women who have unexplained post-donation
febrile illness with headache or other symptoms suggestive
of WNV infection (i.e., flu-like symptoms that include fever
with headache, eye pain, body aches, generalized weakness,
new skin rash or swollen lymph nodes or other evidence of
WNV infection) within two weeks.
10. Pregnant women who have medical history of tuberculosis.
11. Pregnant women who have medical history of malignant
tumor.
12. Fetuses that have found with genetic disease in prenatal
checkups.
13. Pregnant women who would like to store cord blood or
umbilical cord cells, other than this study usage.
14. Pregnant women who are not suitable to donate as judged by
the Investigator(s).
Exclusion Criteria for Study Patients:
1. Patients with recurring stroke attack within 6 months before
this current stroke episode.
2. Patients with signs of midline shift, hemorrhagic
transformation or fluctuation of symptoms.
3. Patients who have participated in other investigational
studies and received any treatment within 4 weeks prior to
receiving UMSC01.
4. Patients who have immuno-compromised condition, or are
with known clinically significantly autoimmune conditions
or are receiving immunosuppressive treatments.
5. Patients who are unable to undergo brain Single-photo
Emission Computed Tomography (SPECT), MRI and PET
scans for any reason.
6. Patients with inadequate hepatic and renal function after
onset of acute ischemic stroke: Aspartate aminotransferase
(AST) and Alanine aminotransferase (ALT) ≥ 5 x upper limit
of normal (ULN); estimated glomerular filtration rate (eGFR)
< 30 mL/min at screening.
7. Patients who have medical history of malignant tumor, spinal
injury or other clinically significant neurological diseases that will confound the evaluation of this study.
8. Patients who have clinically active peripheral neuropathy,
myopathy or other clinically significant neurological
diseases that will confound the evaluation of this study.
9. Patients who have a difference in NIHSS score ≥ 5 between
the time beginning hospitalization and investigational
product (IP) treatment.
10. Patients who are diagnosed of heart failure with a New York
Heart Association (NYHA) score of III or IV.
11. Patients not suitable to participate the trial as judged by the
investigator(s).
The Estimated Number of Participants
-
Taiwan
18 participants
-
Global
18 participants
