ARDSPhase 3NCT05497401
A Controlled Study to Evaluate the Efficacy of Allogeneic MesenCure for the Treatment of Patients With ARDS
A Phase 3 study testing MesenCure in people with ARDS, run by BonusBio Group Ltd.
Trial summary
The efficacy of the allogeneic cell-therapy product MesenCure in addition to standard of care will be evaluated in comparison to placebo control in 300 moderate to severe Covid patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ARDS
- What is being tested?
- MesenCure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Oct 2028
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are able and agree to sign informed consent form before any study-specific procedure.
- Males or females, age range 18-80.
- Documented ARDS
- RA-O2 Saturation of ≤93% and/or Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography
- Stable hemodynamic condition (blood pressure of systolic <180mm Hg and diastolic <110mm Hg)
Who cannot join
- General:
- Pregnant or breast-feeding females.
- History of drug abuse.
- Heavy smokers (above 2 packages a day).
- Subjects incapable of giving consent.
- Background medical conditions:
Show all 20Show fewer
- Known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation.
- History of advanced congestive heart failure or active acute myocardial infarction (AMI), renal failure (estimated GFR of <30 ml/min/1.73 m2 at screening), or hepatic disease (hepatic insufficiency classified as Child-Pugh B or C).
- Known autoimmune diseases.
- Received any investigational drug within 30 days prior to screening day (Visit 1) (Remdesivir is not considered investigational, and is not an exclusion criteria).
- Immunocompromised condition from any reason, at screening.
- Abnormal clinically significant laboratory test findings, as per the investigator's judgment.
- Poorly controlled diabetic subjects (HbA1c > 9%).
- Known active lung malignancy.
- Concomitant treatment:
- Currently treated with Immunosuppressive agents other than corticosteroids used for treating COVID19.
- Treatment for cancer (i.e. chemotherapy or radiotherapy treatment) within the last 12 months.
- Hypersensitivity:
- Known history of hypersensitivity to Dextran-40.
- Known history of hypersensitivity to Human Serum Albumin.
About this study
The efficacy of the allogeneic cell-therapy product MesenCure in addition to standard of care will be evaluated in comparison to placebo control in 300 moderate to severe Covid patients
- Conditions
- ARDS
- Being tested
- MesenCure, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesenCureBiological
Enhanced mesenchymal cell-based product
PlaceboOther
Saline
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Not described Receives: Biological: MesenCure |
| control | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 1 month
CRP reduction
Blood CRP is measured in mg/dL
Measured: 14 days
Invasive ventilation
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study startApr 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BonusBio Group Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497401
- Sponsor's protocol ID
- MCS-03
- Status last verified
- Dec 2024
- First submitted
- 8 Aug 2022
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Study to Evaluate the Efficacy of Allogeneic MesenCure for the Treatment of Patients With ARDS
- ClinicalTrials.gov ID
- NCT05497401
- Acronym / sponsor ID
- MCS-03
- Conditions
- ARDS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- BonusBio Group LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 11 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.
The efficacy of the allogeneic cell-therapy product MesenCure in addition to standard of care will be evaluated in comparison to placebo control in 300 moderate to severe Covid patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Biological: MesenCure |
| control | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients are able and agree to sign informed consent form before any study-specific procedure.
- Males or females, age range 18-80.
- Documented ARDS
- RA-O2 Saturation of ≤93% and/or Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography
- Stable hemodynamic condition (blood pressure of systolic <180mm Hg and diastolic <110mm Hg)
Key exclusion criteria (20 listed)
- Pregnant or breast-feeding females.
- History of drug abuse.
- Heavy smokers (above 2 packages a day).
- Subjects incapable of giving consent.
- Known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation.
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 |
|---|---|---|
| MesenCureEnhanced mesenchymal cell-based product | Biological | treatment |
| PlaceboSaline | Other | control |
Primary outcome
Mortality
Time frame: 1 month
CRP reduction
Time frame: 14 days
Blood CRP is measured in mg/dL
Invasive ventilation
Time frame: 1 month
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 11 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MesenCure in people with ARDS, run by BonusBio Group Ltd.
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 5 inclusion and 20 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: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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?
Mortality (time frame: 1 month). The study lists 3 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 11 Aug 2025.