COVID-19 PneumoniaPhase 1SAMPSON-1NCT05286255
Mesenchymal Stromal Cells for COVID-19 and Viral Pneumonias
A Phase 1 study testing Allogeneic Mesenchymal Stromal Cells in people with COVID-19 Pneumonia and Viral Pneumonia, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This is an open-label phase 1 clinical trial of allogeneic umbilical cord derived mesenchymal stromal cells (MSCs) for hospitalized individuals with COVID-19 or other viral pneumonias. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19 Pneumonia, Viral Pneumonia
- What is being tested?
- Allogeneic Mesenchymal Stromal Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 1 Oct 2024
- Phase
- Phase 1
- 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
- Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing.
- Patient or their surrogate is willing and able to provide written informed consent and comply with all protocol requirements.
- Diagnosis with Mild or Moderate Pneumonia not requiring mechanical ventilation: Patient must have at least one of the following features:
- Bilateral pneumonia present on chest radiograph or computed tomography ii. Partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) on arterial blood gas showing: >100mmHg and ≤ 300mmHg regardless of oxygen dose at time of testing.
- Pulse oxygen saturation (SpO2) at rest ≤ 93% or any degree of hypoxia requiring supplemental oxygen
- Patient agrees to storage of specimens for future testing.
- Willingness to undergo mechanical ventilation for worsening
Who cannot join
- Intubation with mechanical ventilation prior to study enrolment. High flow nasal cannula and non-invasive mechanical ventilation is allowed.
- Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or other viruses
- Obstructive pneumonia induced by lung cancer or other known causes
- Significant comorbid illness likely to impact the outcome of COVID-19 including but not limited to active malignancy other than skin cancer.
- Patients who are participating in other therapeutic clinical trials within 30 days of consent.
- History of long-term use of immunosuppressive agents including prednisone dose >5mg daily over the 30 days prior to enrollment.
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- History of severe chronic respiratory disease and requirement for long-term oxygen therapy
- Undergoing hemodialysis or peritoneal dialysis
- Estimated or actual rate of creatinine clearance < 15 ml/min
- History of moderate and severe liver disease (Child-Pugh score >12)
- Substance abuse sufficient that the patient is unlikely to comply with testing requirements.
- History of deep venous thrombosis, pulmonary embolism, cerebral vascular disease within the last 3 years
- Known HIV, hepatitis virus, or syphilis infection
- Co-Infection of tuberculosis, influenza virus, adenovirus and other respiratory infection virus
- Moribund patient not expected to survive > 24hours
- Allergy to diphenhydramine, or hydrocortisone
- Any condition unsuitable for the study as determined by the investigators
- Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
- Receipt of experimental therapy for COVID-19 with the exception of convalescent plasma, dexamethasone or another corticosteroid, or remdesivir in an open label study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Safety and Tolerability of Allogeneic Umbilical Cord Derived Mesenchymal Stromal Cells (UC-MSCs) to Limit COVID Associated ComplicatioNs: an Open Label, Phase 1 Study in Hospitalized Patients (SAMPSON-1)
This is an open-label phase 1 clinical trial of allogeneic umbilical cord derived mesenchymal stromal cells (MSCs) for hospitalized individuals with COVID-19 or other viral pneumonias. Hospitalized individuals who are within 7 days of the onset of a viral pneumonia will be given 2 doses of MSCs at days 1 and 3 after consent. The safety of intravenous infusion will be tested and course of the oxygen response to treatment over 90 days will be evaluated.
Read the detailed description
Study Design: This open-label phase 1 trial in 10 patients will assess the efficacy and safety of UC-MSCs given on day 1 and 3 in hospitalized patients with acute respiratory symptoms between 1 and 7 days after the onset of symptoms.
The following will be assessed in all subjects:
- Age, sex, comorbidities, date of symptoms, source of infection, type of admission, APACHE II score, SOFA score, Clinical status, vital signs including temperature, respiratory rate, oxygen saturation, oxygen requirement, CBC with neutrophil counts, lymphocyte count, CRP, chest imaging (CT or X-ray), location and status in hospital.
- Safety and efficacy: Day 0 (baseline), 3, and 5. Monitoring at 14, 21 and 28 days and monthly for 3 months will be obtained by telephone consult and chart review with serial laboratory.
- Serum or plasma antibody titer to SARS-CoV-2: Day 0, and 5 (additional days 14, 21 and 28 may be included, as available).
- SARS-CoV-2 PCR from nasopharyngeal swabs: Day 0 and 5. (additional day 14, 28 and 60 day samples may be tested if available or at any time when there is clinical suspicion for COVID-19 persistence).
- Outcome measures: O2 requirement (PaO2/FiO2 ratio or SpO2/FIo2), supplemental oxygen strategy (nasal cannula, high flow nasal cannula, noninvasive ventilation, intubation and invasive mechanical ventilation, neuromuscular blocking agent use, prone positioning, corticosteroids, ECMO), vasopressors, renal support, ICU LOS, ICU mortality, Hospital LOS, Hospital mortality, 28 day mortality.
Study Agent:
- Allogeneic UC-MSCs given intravenously at 1.2-1.5 x 106 cells/kg on day 1 and day 3 of study entry. A maximum dose of 100 x 106 cells would be given in each dose. All cellular product will be given with actively growing cells >24 hours from the time of thawing in the Center for Cellular Therapy (CCT) at MUSC. Any emerging FDA guidance will be followed.
Primary Safety Objective: Evaluate the safety of treatment with UC-MSCs in hospitalized patients with COVID-19 and respiratory symptoms.
Primary Safety Endpoint:
- Rapid deterioration of respiratory or clinical status within 6 hours after transfusion of UC-MSCs
Secondary Safety Endpoints:
- Cumulative incidence of serious adverse events during the study period
- Transfer to intensive care unit (ICU)
- Type and duration of respiratory support (and other ICU support)
- ICU mortality and length of stay
- Hospital mortality and length of stay
- Ventilator-free days
- 28 day mortality
Exploratory Efficacy Objective: Evaluate changes in oxygenation, progression, and regression of viral pneumonias
Efficacy Endpoint: Change from baseline in PaO2/FiO2 ratio at day 5 Biologic Samples will be serially collected to determine mechanisms of effect. Propensity matching of the cohort to the MUSC COVID-19 Biorepository population will provide a population for comparison.
- Conditions
- COVID-19 Pneumonia, Viral Pneumonia
- Being tested
- Allogeneic Mesenchymal Stromal Cells
- Keywords
- Mesenchymal Stromal Cells, ARDS, COVID-19, MSC, Stem Cells
- Medical subject headings
- Pneumonia, Viral, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Mesenchymal Stromal CellsBiological
Intravenous MSCs 1.2-1.5 x 10^6 cells/kg on Days 1 and 3 after study enrollment
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic Mesenchymal Stromal Cell infusion | Experimental | Intravenous infusion of 1.25-1.5 x 10^6 cells/kg with a maximal dose of 100 x 10^6 cells on days 1 and 3 after study enrollment. Receives: Biological: Allogeneic Mesenchymal Stromal Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical deterioration
Change in oxygen saturation or clinical symptoms
Measured: 6 hours
Secondary outcomes (6)
Serious Adverse Events
Cumulative incidence of all serious adverse events
Measured: 90 days
ICU transfer
Need for transfer to an intensive care unit
Measured: 90 days
Respiratory support
Type and duration of respiratory support
Measured: 90 days
Hospital mortality and length of stay
Hospital mortality and length of stay
Measured: 90 days
Ventilator free days
Days off of mechanical ventilation
Measured: 90 Days
28 day mortality
28 day mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Oct 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, single group, Phase 1 study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Pandorum International, Inc.
- Responsible party
- Sponsor
- Investigators
- Charlie Strange, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286255
- Sponsor's protocol ID
- 115966
- Acronym
- SAMPSON-1
- Status last verified
- Oct 2024
- First submitted
- 16 Mar 2022
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Biosamples are stored in the MUSC COVID-19 Biorepository
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Allogeneic Umbilical Cord Derived Mesenchymal Stromal Cells (UC-MSCs) to Limit COVID Associated ComplicatioNs: an Open Label, Phase 1 Study in Hospitalized Patients (SAMPSON-1)
- ClinicalTrials.gov ID
- NCT05286255
- Acronym / sponsor ID
- SAMPSON-1 / 115966
- Conditions
- COVID-19 Pneumonia, Viral Pneumonia
- Keywords
- Mesenchymal Stromal Cells, ARDS, COVID-19, MSC, Stem Cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Pandorum International, Inc.
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 18 Mar 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.
This is an open-label phase 1 clinical trial of allogeneic umbilical cord derived mesenchymal stromal cells (MSCs) for hospitalized individuals with COVID-19 or other viral pneumonias. Hospitalized individuals who are within 7 days of the onset of a viral pneumonia will be given 2 doses of MSCs at days 1 and 3 after consent. The safety of intravenous infusion will be tested and course of the oxygen response to treatment over 90 days will be evaluated.
Detailed description
Study Design: This open-label phase 1 trial in 10 patients will assess the efficacy and safety of UC-MSCs given on day 1 and 3 in hospitalized patients with acute respiratory symptoms between 1 and 7 days after the onset of symptoms.
The following will be assessed in all subjects:
- Age, sex, comorbidities, date of symptoms, source of infection, type of admission, APACHE II score, SOFA score, Clinical status, vital signs including temperature, respiratory rate, oxygen saturation, oxygen requirement, CBC with neutrophil counts, lymphocyte count, CRP, chest imaging (CT or X-ray), location and status in hospital.
- Safety and efficacy: Day 0 (baseline), 3, and 5. Monitoring at 14, 21 and 28 days and monthly for 3 months will be obtained by telephone consult and chart review with serial laboratory.
- Serum or plasma antibody titer to SARS-CoV-2: Day 0, and 5 (additional days 14, 21 and 28 may be included, as available).
- SARS-CoV-2 PCR from nasopharyngeal swabs: Day 0 and 5. (additional day 14, 28 and 60 day samples may be tested if available or at any time when there is clinical suspicion for COVID-19 persistence).
- Outcome measures: O2 requirement (PaO2/FiO2 ratio or SpO2/FIo2), supplemental oxygen strategy (nasal cannula, high flow nasal cannula, noninvasive ventilation, intubation and invasive mechanical ventilation, neuromuscular blocking agent use, prone positioning, corticosteroids, ECMO), vasopressors, renal support, ICU LOS, ICU mortality, Hospital LOS, Hospital mortality, 28 day mortality.
Study Agent:
- Allogeneic UC-MSCs given intravenously at 1.2-1.5 x 106 cells/kg on day 1 and day 3 of study entry. A maximum dose of 100 x 106 cells would be given in each dose. All cellular product will be given with actively growing cells >24 hours from the time of thawing in the Center for Cellular Therapy (CCT) at MUSC. Any emerging FDA guidance will be followed.
Primary Safety Objective: Evaluate the safety of treatment with UC-MSCs in hospitalized patients with COVID-19 and respiratory symptoms.
Primary Safety Endpoint:
- Rapid deterioration of respiratory or clinical status within 6 hours after transfusion of UC-MSCs
Secondary Safety Endpoints:
- Cumulative incidence of serious adverse events during the study period
- Transfer to intensive care unit (ICU)
- Type and duration of respiratory support (and other ICU support)
- ICU mortality and length of stay
- Hospital mortality and length of stay
- Ventilator-free days
- 28 day mortality
Exploratory Efficacy Objective: Evaluate changes in oxygenation, progression, and regression of viral pneumonias
Efficacy Endpoint: Change from baseline in PaO2/FiO2 ratio at day 5 Biologic Samples will be serially collected to determine mechanisms of effect. Propensity matching of the cohort to the MUSC COVID-19 Biorepository population will provide a population for comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, single group, Phase 1 study
| Arm | Type | Receives |
|---|---|---|
| Allogeneic Mesenchymal Stromal Cell infusion | Experimental | Biological: Allogeneic Mesenchymal Stromal CellsIntravenous infusion of 1.25-1.5 x 10^6 cells/kg with a maximal dose of 100 x 10^6 cells on days 1 and 3 after study enrollment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing.
- Patient or their surrogate is willing and able to provide written informed consent and comply with all protocol requirements.
- Diagnosis with Mild or Moderate Pneumonia not requiring mechanical ventilation: Patient must have at least one of the following features:
- Patient agrees to storage of specimens for future testing.
- Willingness to undergo mechanical ventilation for worsening
Key exclusion criteria (19 listed)
- Intubation with mechanical ventilation prior to study enrolment. High flow nasal cannula and non-invasive mechanical ventilation is allowed.
- Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or other viruses
- Obstructive pneumonia induced by lung cancer or other known causes
- Significant comorbid illness likely to impact the outcome of COVID-19 including but not limited to active malignancy other than skin cancer.
- Patients who are participating in other therapeutic clinical trials within 30 days of consent.
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 |
|---|---|---|
| Allogeneic Mesenchymal Stromal CellsIntravenous MSCs 1.2-1.5 x 10^6 cells/kg on Days 1 and 3 after study enrollment | Biological | Allogeneic Mesenchymal Stromal Cell infusion |
Primary outcome
Clinical deterioration
Time frame: 6 hours
Change in oxygen saturation or clinical symptoms
6 secondary outcomes
Serious Adverse Events
Time frame: 90 days
ICU transfer
Time frame: 90 days
Respiratory support
Time frame: 90 days
Hospital mortality and length of stay
Time frame: 90 days
Ventilator free days
Time frame: 90 Days
28 day mortality
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: Yes. Biosamples are stored in the MUSC COVID-19 Biorepository
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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.
Charlie Strange, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Allogeneic Mesenchymal Stromal Cells in people with COVID-19 Pneumonia and Viral Pneumonia, run by Medical University of South Carolina at 1 site 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 7 inclusion and 19 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: withdrawn, as of the sponsor's last update on 30 Oct 2024. 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 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. 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 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Clinical deterioration (time frame: 6 hours). 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 30 Oct 2024.