Mesenchymal Stem CellPhase 3NCT05682586
UC-MSCs in the Treatment of Severe and Critical COVID-19 Patients
A Phase 3 study testing umbilical cord mesenchymal stem cells and paxlovid in people with Mesenchymal Stem Cell and COVID-19 Pneumonia, run by Shanghai East Hospital at 1 site in China.
Trial summary
The goal of this randomized, controlled, open-labeled interventional clinical trial is to test the efficacy and safety of umbilical cord mesenchymal stem cells (UC-MSCs) in the treatment of severe and critical COVID-19 patients. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mesenchymal Stem Cell, COVID-19 Pneumonia
- What is being tested?
- umbilical cord mesenchymal stem cells and paxlovid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2023to 1 Jul 2023
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age ranges from 18 to 75 (inclusive), regardless of gender.
- Patients diagnosed with severe and critical COVID-19 pneumonia within one week, according to the Chinese diagnostic criteria for COVID-19 pneumonia in the Diagnosis and Treatment Plan for COVID-19 Pneumonia (Tentative Ninth Edition).
- 20kg/m2≤body mass index（BMI）≤30 kg/m2.
- Volunteer to participate in this clinical study and sign the written informed consent.
Who cannot join
- Those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation.
- T lymphocyte abnormality (allogeneic may be considered, depending on clinical opinion), HIV positive.
- Highly allergic or have a history of severe allergy, especially Interleukin-2 allergy.
- Pregnant and lactating women.
- Patients with severe autoimmune disease history; Allergies to all biological reagents in this treatment, such as Interleukin-2.
- Patients with serious complications, including chronic cardiac insufficiency (NYHA cardiac function grading assessment of cardiac function grade III - IV), chronic renal insufficiency (CKD stage 3 and above); Chronic liver insufficiency (Child-Pugh score>7); Patients with malignant tumors.
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- Patients with pulmonary embolism or acute coronary syndrome.
- Patients with severe organ dysfunction caused by other diseases.
- There are other situations that the researcher thinks are not suitable to participate in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital, Shanghai Tongji University
Shanghai, Shanghai Municipality, 200120
Zhongmin Liu, Doctor, +86-021-38804518, liu.zhongmin@tongji.edu.cn
About this study
Official title: Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Severe and Critical COVID-19 Patients
The goal of this randomized, controlled, open-labeled interventional clinical trial is to test the efficacy and safety of umbilical cord mesenchymal stem cells (UC-MSCs) in the treatment of severe and critical COVID-19 patients. The main questions it aims to answer are: 1. The efficacy of UC-MSCs in the treatment of severe and critical COVID-19 patients. 2. The safety of UC-MSCs in the treatment of severe and critical COVID-19 patients. 3. The potential immune mechanisms of UC-MSCs in the treatment of severe and critical COVID-19 patients. Participants will receive standard therapy, Paxlovid treatment or the UC-MSCs treatment. For the standard treatment, it will be conducted according the 9th edition of Chinese guidelines for COVID-19 infection. For UC-MSCs treatment, participants will be given UC-MSCs instillation at the first and fourth day after assignment. Blood examples will be taken at indicated time for arterial blood gas analysis and other tests. And participants should also objectively report their symptoms change and other information related to the treatment as listed the research protocol.
- Conditions
- Mesenchymal Stem Cell, COVID-19 Pneumonia
- Being tested
- umbilical cord mesenchymal stem cells, paxlovid
- Keywords
- covid-19 pneumonia, umbilical cord mesenchymal stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord mesenchymal stem cellsBiological
Participants will receive two doses of UC-MSCs treatment, each dose will contain 1*10^6 cells/kg suspended in 100 ml albumin solution.
paxlovidDrug
Participants will receive standard dose of paxlovid therapy, which contains 300mg namatevir and 100mg litonavir twice a day for a total course of 5 days.
| Study group | Role | What they receive |
|---|---|---|
| standard therapy | No intervention | Participants will receive standard therapy, including oxygen therapy，glucocorticoid and other antiinflammatory drugs and supportive treatments according the ninth edition of Chinese guidelines for the treatment of COVID-19 infection. |
| Paxlovid treatment | Active comparator | Participants will receive paxlovid treatment on the basis of standard therapy. Receives: Drug: paxlovid |
| UC-MSCs treatment | Experimental | Participants will receive two doses of UC-MSCs instillation at the first and fourth day after the assignment. Receives: Biological: umbilical cord mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation index
Oxygenation index is the artery partial pressure of oxygen divided by the concentration of inhaled oxygen.
Measured: Change from baseline Oxygenation index (PaO2/FiO2) at 1,3,7,14,28 (or before the day of discharge if participants discharge within 28 days) days after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start9 Jan 2023
- Primary completion31 Mar 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesenchymal Stem CellStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- liu zhongming, Dr., Study chair, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682586
- Sponsor's protocol ID
- DFSC-2022(CR)-05
- Status last verified
- Jan 2023
- First submitted
- 8 Jan 2023
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Severe and Critical COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05682586
- Acronym / sponsor ID
- DFSC-2022(CR)-05
- Conditions
- Mesenchymal Stem Cell, COVID-19 Pneumonia
- Keywords
- covid-19 pneumonia, umbilical cord mesenchymal stem cells
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 12 Jan 2023 (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.
The goal of this randomized, controlled, open-labeled interventional clinical trial is to test the efficacy and safety of umbilical cord mesenchymal stem cells (UC-MSCs) in the treatment of severe and critical COVID-19 patients. The main questions it aims to answer are: 1. The efficacy of UC-MSCs in the treatment of severe and critical COVID-19 patients. 2. The safety of UC-MSCs in the treatment of severe and critical COVID-19 patients. 3. The potential immune mechanisms of UC-MSCs in the treatment of severe and critical COVID-19 patients. Participants will receive standard therapy, Paxlovid treatment or the UC-MSCs treatment. For the standard treatment, it will be conducted according the 9th edition of Chinese guidelines for COVID-19 infection. For UC-MSCs treatment, participants will be given UC-MSCs instillation at the first and fourth day after assignment. Blood examples will be taken at indicated time for arterial blood gas analysis and other tests. And participants should also objectively report their symptoms change and other information related to the treatment as listed the research protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard therapy | No intervention | –Participants will receive standard therapy, including oxygen therapy，glucocorticoid and other antiinflammatory drugs and supportive treatments according the ninth edition of Chinese guidelines for the treatment of COVID-19 infection. |
| Paxlovid treatment | Active comparator | Drug: paxlovidParticipants will receive paxlovid treatment on the basis of standard therapy. |
| UC-MSCs treatment | Experimental | Biological: umbilical cord mesenchymal stem cellsParticipants will receive two doses of UC-MSCs instillation at the first and fourth day after the assignment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The age ranges from 18 to 75 (inclusive), regardless of gender.
- Patients diagnosed with severe and critical COVID-19 pneumonia within one week, according to the Chinese diagnostic criteria for COVID-19 pneumonia in the Diagnosis and Treatment Plan for COVID-19 Pneumonia (Tentative Ninth Edition).
- 20kg/m2≤body mass index（BMI）≤30 kg/m2.
- Volunteer to participate in this clinical study and sign the written informed consent.
Key exclusion criteria (9 listed)
- Those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation.
- T lymphocyte abnormality (allogeneic may be considered, depending on clinical opinion), HIV positive.
- Highly allergic or have a history of severe allergy, especially Interleukin-2 allergy.
- Pregnant and lactating women.
- Patients with severe autoimmune disease history; Allergies to all biological reagents in this treatment, such as Interleukin-2.
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 |
|---|---|---|
| umbilical cord mesenchymal stem cellsParticipants will receive two doses of UC-MSCs treatment, each dose will contain 1*10^6 cells/kg suspended in 100 ml albumin solution. | Biological | UC-MSCs treatment |
| paxlovidParticipants will receive standard dose of paxlovid therapy, which contains 300mg namatevir and 100mg litonavir twice a day for a total course of 5 days. | Drug | Paxlovid treatment |
Primary outcome
Oxygenation index
Time frame: Change from baseline Oxygenation index (PaO2/FiO2) at 1,3,7,14,28 (or before the day of discharge if participants discharge within 28 days) days after the treatment.
Oxygenation index is the artery partial pressure of oxygen divided by the concentration of inhaled oxygen.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
liu zhongming, Dr. study chair
Shanghai East Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing umbilical cord mesenchymal stem cells and paxlovid in people with Mesenchymal Stem Cell and COVID-19 Pneumonia, run by Shanghai East Hospital 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 4 inclusion and 9 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 12 Jan 2023. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 li qiang, Dr. (+86-021-38804518, lqressh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation index (time frame: Change from baseline Oxygenation index (PaO2/FiO2) at 1,3,7,14,28 (or before the day of discharge if participants discharge within 28 days) days after the treatment.). 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 12 Jan 2023.