COVID-19Phase 1/2NCT04331613
Safety and Efficacy of CAStem for Severe COVID-19 Associated With/Without ARDS
A Phase 1/2 study testing CAStem in people with COVID-19 and Acute Respiratory Distress Syndrome, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
A phase1/2, open label, dose escalation, safety and early efficacy study of CAStem for the treatment of severe COVID-19 associated with or without ARDS. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID-19, Acute Respiratory Distress Syndrome, Virus; Pneumonia
- What is being tested?
- CAStem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 27 Jan 2020to Dec 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese patients, aged 18 to 70 years old, males or females;
- Diagnosis of COVID-19, and confirm by chest CT scan;
- According to the diagnosis and treatment plan for the novel coronavirus disease (COVID-19) (trial version 5) issued by the National Health Commission (NHC) on the diagnostic criteria for severe or critical ill COVID-19 patients including the patients with acute respiratory distress syndrome (ARDS), the specific diagnostic criteria are:
- Severely ill patients should meet all of the following:
- 1. Respiratory distress, RR ≥ 30 times/min.
- 2. In a resting state (without oxygen supplementation), oxygen saturation ≤ 93%.
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- 3. Partial arterial oxygen pressure (PaO2) / oxygen absorption concentration (FiO2) ≤ 300 mmHg (1 mmHg = 0.133 kpa). High altitude (above sea level 1000 m) area should be calibrated for PaO2/FiO2 according to the following method: PaO2/FiO2*[atmospheric pressure (mmHg)/760]. Patients with obvious progress in lung lesions by chest CT within 24-48 hours should be counted as the server cases.
- Critically ill patients should meet one of the following :
- 1. Respiratory failure, the mechanical ventilation required.
- 2. Shock.
- 3. Associated with other organ failure, ICU needed for monitoring and management.
- Voluntarily participate in the study, agree to comply with the requirements of the clinical trial protocol, and sign the informed consent.
Who cannot join
- Patients with a history of transplantation of cells or organ(s).
- Patients with a history of malignancy or pathology indicating severe atypical hyperplasia.
- Patients without life expectancy of 48 hours.
- Patients with moderate to severe liver failure (Childs Pugh scores > 12).
- Patients with cardiogenic pulmonary edema.
- Patients with a history of deep vein thrombosis or pulmonary embolism within 3 months before the screening.
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- Patients with severe chronic pulmonary diseases, including but not restricted to the patients with WHO grade III or IV pulmonary hypertension or those with chronic pulmonary diseases requiring long-term oxygen therapy.
- Patients with unstable ventricular tachycardia or ventricular fibrillation.
- Patients with poor coagulation, severe bleeding tendency or active bleeding at present.
- Patients with serious dysfunction involved in the major organs or systems (liver, kidney, gastrointestinal, cardiovascular, blood coagulation, central system, etc.) besides the respiratory system are not suitable to participate in the present study.
- Patients with a history of severe conditions in any organs or systems.
- Patients who are unable to accept other invasive rescue except cardiopulmonary resuscitation.
- Patients who are allergic to the main active ingredients or excipients of the investigational drug.
- Women who are pregnant, breastfeeding or planning to become pregnant during the study period. Woman of childbearing age who is not willing to use appropriate contraceptive methods through the completion of the clinical study.
- Patients whose participation is considered to bring significant risks to the present clinical study, cause confusion in analysis, or significantly interfere with the clinical research results.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing, China, 100000
About this study
Official title: Safety and Efficacy Study of Human Embryonic Stem Cells Derived M Cells (CAStem) for the Treatment of Severe COVID-19 Associated With or Without Acute Respiratory Distress Syndrome (ARDS)
A phase1/2, open label, dose escalation, safety and early efficacy study of CAStem for the treatment of severe COVID-19 associated with or without ARDS.
Read the detailed description
CAStem is an injectable product composed of immunity- and matrix-regulatory cells (IMRCs), also named M cells, differentiated from clinical-grade human embryonic stem cells (hESCs) will be expanded, harvested, and formulated at a concentration of 50 x 10^6 cells/mL. CAStem will be cryopreserved and transported to clinical site using liquid nitrogen vapor shipping vessels (< -150ºC). Prior to injection, CAStem will be thawed to liquefy quickly, and then reconstituted in normal saline.In the present study, the intravenous infusion dose of CAStem will be 3, 5 or 10 million cells/kg.
- Being tested
- CAStem
- Keywords
- CAStem, Stem Cells, Cell Therapy, IMRCs
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome, Pneumonia, Viral, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAStemBiological
CAStem will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| CAStem | Experimental | A dose-escalation with 3 cohorts with 3 patients/cohort who receive doses of 3, 5 or 10 million cells/kg. If there is no safety concerns for each cohort, the dose will be escalated from lower dose to next higher dose. Receives: Biological: CAStem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse reaction (AE) and severe adverse reaction (SAE)
Frequency of adverse reaction (AE) and severe adverse reaction (SAE) within 28 days after treatment
Measured: Within 28 days after treatment
Changes of lung imaging examinations
Evaluation by chest CT
Measured: Within 28 days after treatment
Secondary outcomes (15)
Time to SARS-CoV-2 RT-PCR negative
Marker for SARS-CoV-2
Measured: Within 28 days after treatment
Duration of fever (Celsius)
The duration of a fever above 37.3 degrees Celsius
Measured: Within 28 days after treatment
Changes of blood oxygen (%)
Marker for efficacy
Measured: Within 28 days after treatment
Rate of all-cause mortality within 28 days
Marker for efficacy
Measured: Within 28 days after treatment
Lymphocyte count (*10^9/L)
Counts of lymphocyte in a litre (L) of blood
Measured: Within 28 days after treatment
Alanine aminotransferase (U/L)
Alanine aminotransferase in unit (U)/litre(L)
Measured: Within 28 days after treatment
Creatinine (umol/L)
Creatinine in micromole (umol)/litre(L)
Measured: Within 28 days after treatment
Creatine kinase (U/L)
Creatine kinase in U/L
Measured: Within 28 days after treatment
C-reactive protein (mg/L)
C-reactive in microgram (mg)/litre(L)
Measured: Within 28 days after treatment
Procalcitonin (ng/L)
Procalcitonin in nanogram (ng)/litre(L)
Measured: Within 28 days after treatment
Lactate (mmol/L)
Lactate in millimole(mmol)/litre(L)
Measured: Within 28 days after treatment
IL-1beta (pg/mL)
IL-1beta in picogram(pg)/millilitre(mL)
Measured: Within 28 days after treatment
IL-2 (pg/mL)
IL-2 in pg/mL
Measured: Within 28 days after treatment
IL-6 (pg/mL)
IL-6 in pg/mL
Measured: Within 28 days after treatment
IL-8 (pg/mL)
IL-8 in pg/mL
Measured: Within 28 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start27 Jan 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Beijing YouAn Hospital
- Responsible party
- Principal investigator, Qi Zhou, Chinese Academy of Sciences
- Investigators
- Zhou Qi, Doctor, Principal investigator, Institute of Zoology, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331613
- Sponsor's protocol ID
- ChineseASZQ-006
- Status last verified
- Jan 2020
- First submitted
- 6 Feb 2020
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Human Embryonic Stem Cells Derived M Cells (CAStem) for the Treatment of Severe COVID-19 Associated With or Without Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT04331613
- Acronym / sponsor ID
- ChineseASZQ-006
- Keywords
- CAStem, Stem Cells, Cell Therapy, IMRCs
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- Beijing YouAn Hospital
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 2 Apr 2020 (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.
A phase1/2, open label, dose escalation, safety and early efficacy study of CAStem for the treatment of severe COVID-19 associated with or without ARDS.
Detailed description
CAStem is an injectable product composed of immunity- and matrix-regulatory cells (IMRCs), also named M cells, differentiated from clinical-grade human embryonic stem cells (hESCs) will be expanded, harvested, and formulated at a concentration of 50 x 10^6 cells/mL. CAStem will be cryopreserved and transported to clinical site using liquid nitrogen vapor shipping vessels (< -150ºC). Prior to injection, CAStem will be thawed to liquefy quickly, and then reconstituted in normal saline.In the present study, the intravenous infusion dose of CAStem will be 3, 5 or 10 million cells/kg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAStem | Experimental | Biological: CAStemA dose-escalation with 3 cohorts with 3 patients/cohort who receive doses of 3, 5 or 10 million cells/kg. If there is no safety concerns for each cohort, the dose will be escalated from lower dose to next higher dose. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Chinese patients, aged 18 to 70 years old, males or females;
- Diagnosis of COVID-19, and confirm by chest CT scan;
- According to the diagnosis and treatment plan for the novel coronavirus disease (COVID-19) (trial version 5) issued by the National Health Commission (NHC) on the diagnostic criteria for severe or critical ill COVID-19 patients including the patients with acute respiratory distress syndrome (ARDS), the specific diagnostic criteria are:
- Voluntarily participate in the study, agree to comply with the requirements of the clinical trial protocol, and sign the informed consent.
Key exclusion criteria (15 listed)
- Patients with a history of transplantation of cells or organ(s).
- Patients with a history of malignancy or pathology indicating severe atypical hyperplasia.
- Patients without life expectancy of 48 hours.
- Patients with moderate to severe liver failure (Childs Pugh scores > 12).
- Patients with cardiogenic pulmonary edema.
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 |
|---|---|---|
| CAStemCAStem will be administered intravenously. | Biological | CAStem |
Primary outcome
Adverse reaction (AE) and severe adverse reaction (SAE)
Time frame: Within 28 days after treatment
Frequency of adverse reaction (AE) and severe adverse reaction (SAE) within 28 days after treatment
Changes of lung imaging examinations
Time frame: Within 28 days after treatment
Evaluation by chest CT
15 secondary outcomes
Time to SARS-CoV-2 RT-PCR negative
Time frame: Within 28 days after treatment
Duration of fever (Celsius)
Time frame: Within 28 days after treatment
Changes of blood oxygen (%)
Time frame: Within 28 days after treatment
Rate of all-cause mortality within 28 days
Time frame: Within 28 days after treatment
Lymphocyte count (*10^9/L)
Time frame: Within 28 days after treatment
Alanine aminotransferase (U/L)
Time frame: Within 28 days after treatment
Creatinine (umol/L)
Time frame: Within 28 days after treatment
Creatine kinase (U/L)
Time frame: Within 28 days after treatment
C-reactive protein (mg/L)
Time frame: Within 28 days after treatment
Procalcitonin (ng/L)
Time frame: Within 28 days after treatment
Lactate (mmol/L)
Time frame: Within 28 days after treatment
IL-1beta (pg/mL)
Time frame: Within 28 days after treatment
IL-2 (pg/mL)
Time frame: Within 28 days after treatment
IL-6 (pg/mL)
Time frame: Within 28 days after treatment
IL-8 (pg/mL)
Time frame: Within 28 days after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
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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.
Zhou Qi, Doctor principal investigator
Institute of Zoology, Chinese Academy of Sciences
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 CAStem in people with COVID-19 and Acute Respiratory Distress Syndrome, run by Chinese Academy of Sciences at 1 site in China.
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 12 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 2 Apr 2020. 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 China. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Liu, Doctor (+86-01064807858, wangliu@ioz.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse reaction (AE) and severe adverse reaction (SAE) (time frame: Within 28 days after treatment). 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 2 Apr 2020.