Covid19Phase 2NCT04780685
A Phase II Study in Patients With Moderate to Severe ARDS Due to COVID-19
A Phase 2 study testing hMSC in people with Covid19, run by Stemedica Cell Technologies, Inc. at 2 sites in United States.
Trial summary
This is a Phase II multi-center, double-blind, placebo-controlled, randomized study in Patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- hMSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Mar 2021to 31 Dec 2022
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laboratory-confirmed diagnosis of COVID-19 <= 14 days prior to randomization
- The presence of moderate to severe Acute Respiratory Distress Syndrome (ARDS) as defined by the Berlin Definition:
- Bilateral chest radiograph infiltrates.
- PaO2:FiO2 ratio of less than 200.
- Absence of other clinical conditions that could present in a similar manner (non-infectious pneumonitis, cardiogenic pulmonary edema)
- Absence of moribund state that would indicate imminent demise and poor chance of survival.
Who cannot join
- Females of childbearing potential who are pregnant or unwilling to undergo pregnancy testing; females with a positive pregnancy test on screening day will be excluded.
- Breastfeeding mothers
- Patients on ECMO
- Receiving concurrent treatment with an investigational agent in a clinical trial.
- Exception: Use of COVID-19 convalescent plasma is permitted.
- More than 72hrs on mechanical ventilation before randomization
- Receiving concurrent investigational vaccine
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Providence Medical Foundation
Fullerton, California, 92835
Linda Gozar, MPH, 714-992-3000 ext. 4332, Linda.Gozar@stjoe.org
David Park, MD
- Recruiting
Providence Saint John's Health Center - Saint John's Cancer Institute
Santa Monica, California, 90404
Hotline, 310-582-7448, neuro.research@providence.org
Santosh Kesari, MD
About this study
Official title: A Phase II, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Patients With Moderate to Severe ARDS Due to COVID-19
This is a Phase II multi-center, double-blind, placebo-controlled, randomized study in Patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens.
Read the detailed description
This is a Phase II multi-center, double-blind, placebo-controlled, randomized study in Patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens. The study will enroll up to 40 Patients into two cohorts, randomized 1:1 to receive active study drug plus standard treatment or placebo (LRS) plus standard treatment. On the treatment (Day 0) Cohort 1 will receive a single IV dose of hMSCs Cohort 2 will receive Lactated Ringer's Solution. A second dose of MSCs or LRS will be given to Cohort 1 or Cohort 2, respectively on Day 3 after the first dose. Patients who discontinue the study before Month 1 for reasons other than adverse events will be replaced.
- Conditions
- Covid19
- Being tested
- hMSC
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hMSCBiological
Also called allogeneic mesenchymal bone marrow cells
IV administration
| Study group | Role | What they receive |
|---|---|---|
| hMSCs | Experimental | hMSCs will be given via IV administration. Receives: Biological: hMSC |
| Lactated Ringer's Solution | Placebo comparator | Lactated Ringer's Solution will be given via IV administration. Receives: Biological: hMSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Number of patients alive at day 14 post treatment
Measured: 14 days post treatment
Secondary outcomes (1)
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0
Frequency of adverse events in patients treated with hMSCs and Lactate Ringer's solutions will be compared.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start20 Mar 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stemedica Cell Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- bioRASI, LLC
- Responsible party
- Sponsor
- Investigators
- Lev Verkh, PhD/MS, Study director, Stemedica Cell Technologies, Inc.Santosh Kesari, MD, Principal investigator, Providence Saint John's Health Center - Saint John's Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780685
- Sponsor's protocol ID
- STEM-107-COVID-19
- Status last verified
- Jul 2022
- First submitted
- 1 Mar 2021
- Last updated
- 8 Jul 2022
- Results posted
- 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 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Patients With Moderate to Severe ARDS Due to COVID-19
- ClinicalTrials.gov ID
- NCT04780685
- Acronym / sponsor ID
- STEM-107-COVID-19
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Stemedica Cell Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- bioRASI, LLC
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 Mar 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.
This is a Phase II multi-center, double-blind, placebo-controlled, randomized study in Patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens.
Detailed description
This is a Phase II multi-center, double-blind, placebo-controlled, randomized study in Patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens. The study will enroll up to 40 Patients into two cohorts, randomized 1:1 to receive active study drug plus standard treatment or placebo (LRS) plus standard treatment. On the treatment (Day 0) Cohort 1 will receive a single IV dose of hMSCs Cohort 2 will receive Lactated Ringer's Solution. A second dose of MSCs or LRS will be given to Cohort 1 or Cohort 2, respectively on Day 3 after the first dose. Patients who discontinue the study before Month 1 for reasons other than adverse events will be replaced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hMSCs | Experimental | Biological: hMSChMSCs will be given via IV administration. |
| Lactated Ringer's Solution | Placebo comparator | Biological: hMSCLactated Ringer's Solution will be given via IV administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Laboratory-confirmed diagnosis of COVID-19 <= 14 days prior to randomization
- The presence of moderate to severe Acute Respiratory Distress Syndrome (ARDS) as defined by the Berlin Definition:
- Absence of moribund state that would indicate imminent demise and poor chance of survival.
Key exclusion criteria (7 listed)
- Females of childbearing potential who are pregnant or unwilling to undergo pregnancy testing; females with a positive pregnancy test on screening day will be excluded.
- Breastfeeding mothers
- Patients on ECMO
- Receiving concurrent treatment with an investigational agent in a clinical trial.
- Exception: Use of COVID-19 convalescent plasma is permitted.
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 |
|---|---|---|
| hMSCAlso: allogeneic mesenchymal bone marrow cellsIV administration | Biological | Lactated Ringer's Solution, hMSCs |
Primary outcome
Survival
Time frame: 14 days post treatment
Number of patients alive at day 14 post treatment
1 secondary outcome
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- 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.
Lev Verkh, PhD/MS study director
Stemedica Cell Technologies, Inc.
Santosh Kesari, MD principal investigator
Providence Saint John's Health Center - Saint John's Cancer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hMSC in people with Covid19, run by Stemedica Cell Technologies, Inc. at 2 sites in United States.
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 6 inclusion and 7 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 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 phase mean?
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 Lev Verkh, PhD/MS (8586580910, lverkh@stemedica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 14 days post 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 8 Jul 2022.