Covid19Phase 1/2NCT04716998
Safety and the Efficacy of MesenCure for the Treatment of Pulmonary Manifestations of COVID-19
A Phase 1/2 study testing MesenCure in people with Covid19, run by BonusBio Group Ltd at 3 sites in Israel.
Trial summary
An open label clinical study to evaluate the safety and the efficacy of MesenCure, an allogeneic cell therapy product, for the treatment of the pulmonary manifestations in COVID19 patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19
- What is being tested?
- MesenCure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesIsrael
- Study dates
- 14 Jan 2021to 31 Jan 2022
- 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 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.
- Female subjects are eligible only if of non-child bearing potential.
- Documented COVID19
- O2 Saturation of ≤93%
- Stable hemodynamic condition (blood pressure of systolic <180mm Hg and diastolic <110mm Hg)
- Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography.
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:
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- Known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation.
- History of significant heart diseases, 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 (HypoThermosol®).
- Known history of hypersensitivity to Human Serum Albumin.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Rambam Health campus
Haifa, 3109601
Kaplan Medical Center
Rehovot, Israel, 7661041
BARUCH PADEH Medical Center, Poriya
Tiberias, Israel, 15208
About this study
Official title: A Controlled Study to Evaluate the Safety and Efficacy of Allogeneic MesenCure for the Treatment of Pulmonary Manifestations in Patients With COVID19
An open label clinical study to evaluate the safety and the efficacy of MesenCure, an allogeneic cell therapy product, for the treatment of the pulmonary manifestations in COVID19 patients
Read the detailed description
Primary endpoint: The IV administration of MesenCure is safe under the following conditions: in subjects hospitalized with COVID19 moderate to severe disease, defined upon clinical situation and radiologic findings.
Secondary endpoint: The IV administration of MesenCure is efficacious under the following conditions:
Clinical parameters: Health questionnaire, respiratory rate, heart rate, blood pressure, RA O2 saturation, hospitalization duration.
______________________________________________________ Laboratory findings: leukocyte and lymphocyte count, CRP, D-Dimer, renal and liver function, optional: cytokine levels.
______________________________________________________ Radiologic findings: pulmonary infiltrates, pleural effusion.
- Conditions
- Covid19
- Being tested
- MesenCure
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesenCureBiological
Three administrations of MesenCure in addition to standard care
| Study group | Role | What they receive |
|---|---|---|
| MesenCure treatment | Experimental | Clinical interventions:
Health questionnaire, respiratory rate, heart rate, blood pressure, RA O2 saturation, x-ray.
Blood tests: leukocyte and lymphocyte count, CRP, D-Dimer, renal and liver function, optional: cytokine levels. Receives: Biological: MesenCure |
| Retrospective control group | No intervention | A retrospective control group based on historical data of 150 matching subjects meeting the eligibility criteria and treated with SOC alone was included, following algorithmic stratifications against the treatment group based on gender, age, and comorbidities. The control group consisted of patients hospitalized during the same year as the treatment group and in the same medical centers as the treatment group patients. The control group patients closely resembled those in the treatment group, with similar or lower ordinal clinical scores and frequencies of comorbidities, helping to avoid bias in favor of the treatment group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Mesencure
No treatment-related adverse reactions
Measured: 30 days
Secondary outcomes (6)
Improvement in RA-O2 saturation
Elevation to 94% and above
Measured: 14 days
Elevation of lymphocytes level
Elevation compared to day 0
Measured: 14 days
Reduction of CRP
Reduction compared to day 0
Measured: 14 days
Improvement of health questionnaire
Improvement compared to day 0
Measured: 21 days
Reduced hospitalization duration
Reduced compared to clinical site matching historical data
Measured: 30 days
improvement in pulmonary infiltrates/ pulmonary congestion
Improvement compared to day 0
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start14 Jan 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- The treatment group consisted of 50 patients, treated with MesenCure in addition to the standard of care (SoC). A retrospective control group based on historical data of 150 matching subjects meeting the eligibility criteria and treated with SoC alone was included, following algorithmic stratifications against the treatment group based on gender, age, and comorbidities. The control group consisted of patients hospitalized during the same year as the treatment group and in the same medical centers as the treatment group patients. The control group patients closely resembled those in the treatment group, with similar or lower ordinal clinical scores and frequencies of comorbidities, helping to avoid bias in favor of the treatment group.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- BonusBio Group Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shadi Hamoud, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716998
- Sponsor's protocol ID
- CP-MCS-01
- Status last verified
- Aug 2025
- First submitted
- 17 Jan 2021
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Study to Evaluate the Safety and Efficacy of Allogeneic MesenCure for the Treatment of Pulmonary Manifestations in Patients With COVID19
- ClinicalTrials.gov ID
- NCT04716998
- Acronym / sponsor ID
- CP-MCS-01
- Conditions
- Covid19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- BonusBio Group LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 20 Jan 2021 (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.
An open label clinical study to evaluate the safety and the efficacy of MesenCure, an allogeneic cell therapy product, for the treatment of the pulmonary manifestations in COVID19 patients
Detailed description
Primary endpoint: The IV administration of MesenCure is safe under the following conditions: in subjects hospitalized with COVID19 moderate to severe disease, defined upon clinical situation and radiologic findings.
Secondary endpoint: The IV administration of MesenCure is efficacious under the following conditions:
Clinical parameters: Health questionnaire, respiratory rate, heart rate, blood pressure, RA O2 saturation, hospitalization duration.
______________________________________________________ Laboratory findings: leukocyte and lymphocyte count, CRP, D-Dimer, renal and liver function, optional: cytokine levels.
______________________________________________________ Radiologic findings: pulmonary infiltrates, pleural effusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The treatment group consisted of 50 patients, treated with MesenCure in addition to the standard of care (SoC). A retrospective control group based on historical data of 150 matching subjects meeting the eligibility criteria and treated with SoC alone was included, following algorithmic stratifications against the treatment group based on gender, age, and comorbidities. The control group consisted of patients hospitalized during the same year as the treatment group and in the same medical centers as the treatment group patients. The control group patients closely resembled those in the treatment group, with similar or lower ordinal clinical scores and frequencies of comorbidities, helping to avoid bias in favor of the treatment group.
| Arm | Type | Receives |
|---|---|---|
| MesenCure treatment | Experimental | Biological: MesenCureClinical interventions: Health questionnaire, respiratory rate, heart rate, blood pressure, RA O2 saturation, x-ray. Blood tests: leukocyte and lymphocyte count, CRP, D-Dimer, renal and liver function, optional: cytokine levels. |
| Retrospective control group | No intervention | –A retrospective control group based on historical data of 150 matching subjects meeting the eligibility criteria and treated with SOC alone was included, following algorithmic stratifications against the treatment group based on gender, age, and comorbidities. The control group consisted of patients hospitalized during the same year as the treatment group and in the same medical centers as the treatment group patients. The control group patients closely resembled those in the treatment group, with similar or lower ordinal clinical scores and frequencies of comorbidities, helping to avoid bias in favor of the treatment group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients are able and agree to sign informed consent form before any study-specific procedure.
- Males or females, age range 18-80.
- Female subjects are eligible only if of non-child bearing potential.
- Documented COVID19
- O2 Saturation of ≤93%
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 |
|---|---|---|
| MesenCureThree administrations of MesenCure in addition to standard care | Biological | MesenCure treatment |
Primary outcome
Safety of Mesencure
Time frame: 30 days
No treatment-related adverse reactions
6 secondary outcomes
Improvement in RA-O2 saturation
Time frame: 14 days
Elevation of lymphocytes level
Time frame: 14 days
Reduction of CRP
Time frame: 14 days
Improvement of health questionnaire
Time frame: 21 days
Reduced hospitalization duration
Time frame: 30 days
improvement in pulmonary infiltrates/ pulmonary congestion
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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. This study is not recruiting at the moment.
Shadi Hamoud, MD principal investigator
Rambam Health Care Campus
3 sites 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 MesenCure in people with Covid19, run by BonusBio Group Ltd at 3 sites in Israel.
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 7 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: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety of Mesencure (time frame: 30 days). 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 Aug 2025.