COVID-19 InfectionPhase 1/2UMSC01NCT05501418
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With COVID-19
A Phase 1/2 study testing Allogeneic umbilical cord mesenchymal stem cells in people with COVID-19 Infection, run by Ever Supreme Bio Technology Co., Ltd. at 1 site in Taiwan.
Trial summary
This study is to explore the safety and efficacy of using UCMSC01 in patients with COVID-19 infection via IV stem cell administration. The novelty of the current UMSC01 treatment is the single IV infusion of UMSC01 to the worldwide emergency outbreaks of COVID-19. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- Allogeneic umbilical cord mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Aug 2020to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 20 to 80 years old.
- Hospitalized severe and critical COVID-19 patients with laboratory confirmation by reverse-transcription polymerase chain reaction (RT-PCR) from nasopharyngeal/ oropharyngeal samples collected using standardized method.
- Pneumonia or interstitial lung damage that is confirmed by chest radiographs or computed tomography.
- Severe COVID-19 infection which meets any one of the following: 1) dyspnea (PR ≥ 30 times/min), 2) finger oxygen saturation ≤ 93% in the room air and resting state, 3) arterial oxygen partial pressure (PaO2)/oxygen absorption concentration (FiO2) ≤ 300 mmHg, 4) pulmonary imaging which shows that the focus progress > 50% within 24-48 hours, or
- Critically severe COVID-19 infection which meets any of the following: 1) respiratory failure treated by mechanical ventilation, 2) shock, 3) combined with other organ failure, 4) patients expected to need ICU monitoring and treatment.
- High sensitivity C-reactive protein (hs-CRP) serum level > 4.0 mg/dL.
Show all 13Show fewer
- All 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 and agree to maintain such contraceptive method(s) for another 4 weeks after UMSC01 treatment.
- 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.
- Female sterilization (bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, the reproductive status of the woman should be confirmed by the hormone level assessment.
- Male sterilization (at least 6 months prior to screening). For female subjects in the study, the vasectomized male partner should be the sole partner for that subject.
- 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%), such as 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.
Who cannot join
- Pregnancy, lactation, and those who are not pregnant but did not, or unwilling to, take effective contraceptives measures 4 weeks before and after the treatment.
- Patients with malignant tumors or other serious systemic diseases.
- Patients with hemoglobin < 10 g, alanine aminotransferase (ALT) ≥ 5 × ULN, aspartate aminotransferase (AST) ≥ 5 × ULN, alkaline phosphatase (ALP) ≥ 5 × ULN, total bilirubin (TBILI) ≥ 2 × ULN, serum creatinine > 2.5 mg/dl, platelet counts < 100,000/μL, WBC < 3,000 cells/μL, or neutrophil counts < 1,000/μL at screening.
- Presence of barotrauma or hemodynamic instability defined as hypotension with diastolic blood pressure < 90 mmHg or mean arterial pressure (MAP) < 70 mmHg despite fluid expansion, and vasoactive support or pneumothorax at screening.
- Uncontrolled hypertension with systolic blood pressure > 170 mmHg and diastolic blood pressure > 100 mmHg which, in the investigator's judgment, would not make participation appropriate.
- Recent history of (within 2 years) ischemic heart disease or cerebrovascular attack, such as myocardial infarction, unstable angina, or stroke.
Show all 13Show fewer
- Recent history (within 2 years) of hypercoagulable disorder, antiphospholipid syndrome, pulmonary embolism, or deep venous thrombosis.
- Condition other than COVID-19 that is projected to limit lifespan to ≤ 1 year.
- History of drug or alcohol abuse within the past 24 months.
- Unwilling to commit to follow-up visits.
- Patients who are participating in other clinical trials with an investigational product.
- Co-infection of HIV, tuberculosis, influenza virus, adenovirus, and other respiratory infection virus.
- Patients with other conditions that are not suitable to participate in this clinical study as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Seamless Phase I/IIa Clinical Study to Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Severe and Critical COVID-19 Condition
This study is to explore the safety and efficacy of using UCMSC01 in patients with COVID-19 infection via IV stem cell administration. The novelty of the current UMSC01 treatment is the single IV infusion of UMSC01 to the worldwide emergency outbreaks of COVID-19. We hypothesize that sufficient UMSC01 retention in lung may modulate the systemic inflammatory responses.
Read the detailed description
The lead Phase I safety phase will further confirm the safety profile of UMSC01 in 5 COVID-19 patients each at two dose regimens and placebo.
To start the Phase IIa study, data analysis will be performed as soon as the 21-day treatment period has been completed in the three groups. With considerations of the pandemic status and clinical practice, only one of the two active treatment groups will be selected to complete the Phase IIa study, which will recruit 60 patients.
- Conditions
- COVID-19 Infection
- Being tested
- Allogeneic umbilical cord mesenchymal stem cells, Controlled normal saline
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic umbilical cord mesenchymal stem cellsBiological
UMSC01 cells will be IV infusion with 12 months of follow up after treatment.
Controlled normal salineBiological
Normal saline will be IV infusion with 12 months of follow up after treatment.
| Study group | Role | What they receive |
|---|---|---|
| UMSC01 | Experimental | UMSC01 cells mixed with normal saline will be administered to patients after COVID-19 infection. Receives: Biological: Allogeneic umbilical cord mesenchymal stem cells |
| Placebo | Placebo comparator | Normal saline will be administered to patients after COVID-19 infection. Receives: Biological: Controlled normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two Co-Primary Efficacy Endpoints
Proportion of patients alive with sustained improvement within the 21 days of the treatment period (Proportion Analysis), which indicates the capability of UMSC01 to save more lives
Measured: 21 days of the treatment period
Two Co-Primary Efficacy Endpoints
Time (days) to reach sustained improvement within the 21 days of the treatment period (Time-to-Event Analysis), which indicates the capability of UMSC01 to enable patients to less suffer from the disease condition.
Measured: 21 days of the treatment period
Secondary outcomes (15)
Secondary Efficacy Endpoints
Proportion of enrolled patients alive on Day 21
Measured: 21 days of the treatment period
Secondary Efficacy Endpoints
Proportion of enrolled patients alive and free of respiratory failure on Day 21
Measured: 21 days of the treatment period
Secondary Efficacy Endpoints
Improvement of COVID 19 pneumonia confirmed by chest radiographs or computed tomography on Day 21 or on the day of discharge compared with baseline
Measured: 21 days of the treatment period
Secondary Efficacy Endpoints
Improvement of clinical symptoms including duration of fever in degrees C and respiratory failure on Day 21 or on the day of discharge compared with baseline
Measured: 21 days of the treatment period
Secondary Efficacy Endpoints
Duration of ventilator usage or oxygen therapy on Day 21 or on the day of discharge compared with baseline
Measured: 21 days of the treatment period
Secondary Efficacy Endpoints
Levels of tumor necrosis factor-alpha (TNF-α) in pg/ml, interleukin-6 (IL-6) in pg/ml and interleukin-10 (IL-10) in pg/ml, and C-reactive protein (hsCRP) in mg/dl on Day 21 or on the day of discharge compared to baseline
Measured: 21 days of the treatment period
Secondary Efficacy Endpoints
Troponin I level as assessed via serum blood samples on Day 21 or on the day of discharge compared with baseline
Measured: 21 days of the treatment period
Secondary Efficacy Endpoints
ICU admission rate on Day 21 or on the day of discharge with historical data
Measured: 21 days of the treatment period
Secondary Efficacy Endpoints
Percentage of subjects recorded in each severity rating based on Clinical classification of the COVID-19 (NCOSS scores from 1 to 8；higher scores mean a worse outcome) on Day 14 compared with historical data
Measured: 14 days of the treatment period
Secondary Efficacy Endpoints
Percentage of subjects recorded in each severity rating based on Clinical classification of the COVID-19 (NCOSS scores from 1 to 8；higher scores mean a worse outcome) on Day 21 compared with historical data
Measured: 21 days of the treatment period
Secondary Efficacy Endpoints
Average time (days) for which the patients are alive and free of respiratory failure during the treatment period
Measured: through study completion, an average of 1 year
Secondary Efficacy Endpoints
Proportion of patients who need ICU care on Day 21 based on the clinical indicative of admission to ICU
Measured: 21 days of the treatment period
Secondary Efficacy Endpoints
Proportion of patients who has been discharged form hospital on Day 21
Measured: 21 days of the treatment period
Secondary Safety Endpoints
Number of Participants with infusion-related and allergic reactions during the treatment period
Measured: 21 days of the treatment period
Secondary Safety Endpoints
Secondary infection, treatment emergent adverse event (TEAE), serious adverse event (SAE), and suspected and unexpected serious adverse reaction (SUSAR) incidences over the study period. The toxicities will be assessed by CTCAE V5.0 during the whole study period (380 days)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start5 Aug 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ever Supreme Bio Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Woei C Shyu, Study director, Ever Supreme Bio Technology Co., Ltd.Long Bin Jeng, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501418
- Sponsor's protocol ID
- ES-CMSC01-C1101
- Acronym
- UMSC01
- Status last verified
- Sep 2026
- First submitted
- 10 Aug 2022
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Seamless Phase I/IIa Clinical Study to Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Severe and Critical COVID-19 Condition
- ClinicalTrials.gov ID
- NCT05501418
- Acronym / sponsor ID
- UMSC01 / ES-CMSC01-C1101
- Conditions
- COVID-19 Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ever Supreme Bio Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to explore the safety and efficacy of using UCMSC01 in patients with COVID-19 infection via IV stem cell administration. The novelty of the current UMSC01 treatment is the single IV infusion of UMSC01 to the worldwide emergency outbreaks of COVID-19. We hypothesize that sufficient UMSC01 retention in lung may modulate the systemic inflammatory responses.
Detailed description
The lead Phase I safety phase will further confirm the safety profile of UMSC01 in 5 COVID-19 patients each at two dose regimens and placebo.
To start the Phase IIa study, data analysis will be performed as soon as the 21-day treatment period has been completed in the three groups. With considerations of the pandemic status and clinical practice, only one of the two active treatment groups will be selected to complete the Phase IIa study, which will recruit 60 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UMSC01 | Experimental | Biological: Allogeneic umbilical cord mesenchymal stem cellsUMSC01 cells mixed with normal saline will be administered to patients after COVID-19 infection. |
| Placebo | Placebo comparator | Biological: Controlled normal salineNormal saline will be administered to patients after COVID-19 infection. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female aged 20 to 80 years old.
- Hospitalized severe and critical COVID-19 patients with laboratory confirmation by reverse-transcription polymerase chain reaction (RT-PCR) from nasopharyngeal/ oropharyngeal samples collected using standardized method.
- Pneumonia or interstitial lung damage that is confirmed by chest radiographs or computed tomography.
- Severe COVID-19 infection which meets any one of the following: 1) dyspnea (PR ≥ 30 times/min), 2) finger oxygen saturation ≤ 93% in the room air and resting state, 3) arterial oxygen partial pressure (PaO2)/oxygen absorption concentration (FiO2) ≤ 300 mmHg, 4) pulmonary imaging which shows that the focus progress > 50% within 24-48 hours, or
- Critically severe COVID-19 infection which meets any of the following: 1) respiratory failure treated by mechanical ventilation, 2) shock, 3) combined with other organ failure, 4) patients expected to need ICU monitoring and treatment.
Key exclusion criteria (13 listed)
- Pregnancy, lactation, and those who are not pregnant but did not, or unwilling to, take effective contraceptives measures 4 weeks before and after the treatment.
- Patients with malignant tumors or other serious systemic diseases.
- Patients with hemoglobin < 10 g, alanine aminotransferase (ALT) ≥ 5 × ULN, aspartate aminotransferase (AST) ≥ 5 × ULN, alkaline phosphatase (ALP) ≥ 5 × ULN, total bilirubin (TBILI) ≥ 2 × ULN, serum creatinine > 2.5 mg/dl, platelet counts < 100,000/μL, WBC < 3,000 cells/μL, or neutrophil counts < 1,000/μL at screening.
- Presence of barotrauma or hemodynamic instability defined as hypotension with diastolic blood pressure < 90 mmHg or mean arterial pressure (MAP) < 70 mmHg despite fluid expansion, and vasoactive support or pneumothorax at screening.
- Uncontrolled hypertension with systolic blood pressure > 170 mmHg and diastolic blood pressure > 100 mmHg which, in the investigator's judgment, would not make participation appropriate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic umbilical cord mesenchymal stem cellsUMSC01 cells will be IV infusion with 12 months of follow up after treatment. | Biological | UMSC01 |
| Controlled normal salineNormal saline will be IV infusion with 12 months of follow up after treatment. | Biological | Placebo |
Primary outcome
Two Co-Primary Efficacy Endpoints
Time frame: 21 days of the treatment period
Proportion of patients alive with sustained improvement within the 21 days of the treatment period (Proportion Analysis), which indicates the capability of UMSC01 to save more lives
Two Co-Primary Efficacy Endpoints
Time frame: 21 days of the treatment period
Time (days) to reach sustained improvement within the 21 days of the treatment period (Time-to-Event Analysis), which indicates the capability of UMSC01 to enable patients to less suffer from the disease condition.
15 secondary outcomes
Secondary Efficacy Endpoints
Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
Time frame: 14 days of the treatment period
Secondary Efficacy Endpoints
Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
Time frame: through study completion, an average of 1 year
Secondary Efficacy Endpoints
Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
Time frame: 21 days of the treatment period
Secondary Safety Endpoints
Time frame: 21 days of the treatment period
Secondary Safety Endpoints
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Related trials for COVID-19 Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woei C Shyu study director
Ever Supreme Bio Technology Co., Ltd.
Long Bin Jeng principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allogeneic umbilical cord mesenchymal stem cells in people with COVID-19 Infection, run by Ever Supreme Bio Technology Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two Co-Primary Efficacy Endpoints (time frame: 21 days of the treatment period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.