COVID-19Phase 1/2NCT04445220
A Study of Cell Therapy in COVID-19 Subjects With Acute Kidney Injury Who Are Receiving Renal Replacement Therapy
A Phase 1/2 study testing SBI-101 in people with COVID-19 and Acute Kidney Injury, run by Sentien Biotechnologies, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in subjects with an infectious etiology of Acute Kidney Injury (AKI). SBI-101 is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Acute Kidney Injury, Sepsis
- What is being tested?
- SBI-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Nov 2020to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented evidence of infection, e.g., positive PCR for COVID-19, positive blood cultures for systemic infection, active urinary sediment to suggest UTI, or any imaging supportive of a clinical diagnosis of infection, for example, pulmonary infiltrate on chest x-ray to suggest pneumonia, pancreatitis on CT imaging, abdominal collection, etc.
- AKI as determined by the Investigator based on his/her clinical judgment
- Receiving or planned to receive RRT in < 24 hours
- Able to tolerate indwelling intravascular access
- Has tolerated CRRT for at least 6 hours prior to IP treatment
- Have maintained hemodynamic stability for at least 6 hours prior to IP treatment with only minor changes in pressure support medication required (if used)
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- Vascular access (catheter placement) is patent and capable of supporting CRRT for the duration of IP treatment
- Likely to require RRT for at least an additional 48 hours
- Potassium level >3.6 and <5.5 mEq/L or >3.6 and < 5.5 mmol/L prior to IP treatment
- SaO2 > 92% prior to IP initiation
- Blood pH > 7.2 prior to IP initiation
- Medically cleared to receive anticoagulation per institutional standard of care / PI prescribed protocol and meeting protocol defined anticoagulation targets prior to receipt of IP
- Ability to give informed consent or have a legally authorized representative do so
Who cannot join
- Female subjects who are pregnant, planning to become pregnant, or lactating
- MAP <70 mmHg immediately prior to IP initiation
- Systolic blood pressure < 90 mmHg immediately prior to IP initiation
- Mechanical ventilator support requiring FiO2 > 80% prior to IP initiation
- Receiving extracorporeal membrane oxygenation (ECMO)
- Liver disease with Child Pugh score of > 7 prior to IP initiation
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- High sensitivity cardiac Troponin level (hs-cTn) > 100.0 ng/L prior to IP initiation or other equivalent Troponin test result prior to IP initiation
- Hepatorenal syndrome
- AKI due to post-renal outflow obstruction
- Acute or chronic vasculitis of any etiology
- Chronic systemic infection
- Subjects with a past medical history of an inherited or acquired hypercoagulable condition independent of COVID-19
- Patients with a past medical history of an allergic response to MSC therapy
- Participation in another interventional trial with the exception of studies of antivirals, corticosteroids, hydroxychloroquine, azithromycin, or angiotensin converting enzyme inhibitors/angiotensin receptor blockers (or related compounds)
- Active malignancy(-ies) and/or receiving active treatment for a malignancy(-ies), with the exception of non-melanoma skin cancer
- Subjects, who in the opinion of the Investigator, are likely to require escalating doses of vasopressors to attain and/or maintain hemodynamic stability, or subjects who have reached the institutionally defined maximum level of vasopressor support within 12 hours of intended IP integration
- Imminent death in <24 hours
- Organ failure affecting more than 2 non-renal organs
- Platelet count <50,000/μL or other serious hematological abnormalities that would place subject in imminent danger of death
- Lactate levels >8 mmol/L suggestive of severe end-organ hypoperfusion prior to the time of IP integration
- Any prior medical condition or recent surgical procedure, planned significant medical interventions or procedures that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of New Mexico School of Medicine
Albuquerque, New Mexico, 87106
Medical University of South Carolina
Charleston, South Carolina, 29407
About this study
Official title: A Multi-center, Randomized, Case Controlled, Double-blind, Ascending-dose Study of Extracorporeal Mesenchymal Stromal Cell Therapy (SBI-101 Therapy) in COVID-19 Subjects With Acute Kidney Injury Receiving Renal Replacement Therapy
The purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in subjects with an infectious etiology of Acute Kidney Injury (AKI). SBI-101 is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal cells. SBI-101 will be integrated into the renal replacement circuit and patients will be treated for up to 24 hours.
- Conditions
- COVID-19, Acute Kidney Injury, Sepsis
- Being tested
- SBI-101
- Keywords
- CRRT, AKI, Continuous renal replacement therapy, MSC, Mesenchymal stromal cells, Mesenchymal stem cells, Stem cells, Cell therapy
- Medical subject headings
- COVID-19, Acute Kidney Injury, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBI-101Biological
SBI-101 is a biologic/device combination product that combines two components: allogeneic human mesenchymal stromal cells (MSCs) and an FDA-approved plasmapheresis device. SBI-101 is administered via integration into a Continuous Renal Replacement Therapy circuit and is designed to regulate inflammation and promote repair of injured tissue.
| Study group | Role | What they receive |
|---|---|---|
| Low dose cohort | Experimental | SBI-101 device containing 250 million MSCs Receives: Biological: SBI-101 |
| High dose cohort | Experimental | SBI-101 device containing 750 million MSCs Receives: Biological: SBI-101 |
| Case controls | No intervention | Case control subjects will receive only standard-of-care treatment and will be followed for the same safety assessments as active study participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as measured by incidence of IP-related serious adverse events
Measured: Outcomes and Serious Adverse Events through Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start19 Nov 2020
- Primary completionMar 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sentien Biotechnologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445220
- Sponsor's protocol ID
- SBI-101-02
- Status last verified
- Aug 2021
- First submitted
- 22 Jun 2020
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Case Controlled, Double-blind, Ascending-dose Study of Extracorporeal Mesenchymal Stromal Cell Therapy (SBI-101 Therapy) in COVID-19 Subjects With Acute Kidney Injury Receiving Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT04445220
- Acronym / sponsor ID
- SBI-101-02
- Conditions
- COVID-19, Acute Kidney Injury, Sepsis
- Keywords
- CRRT, AKI, Continuous renal replacement therapy, MSC, Mesenchymal stromal cells, Mesenchymal stem cells, Stem cells, Cell therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Sentien Biotechnologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 24 Jun 2020 (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 purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in subjects with an infectious etiology of Acute Kidney Injury (AKI). SBI-101 is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal cells. SBI-101 will be integrated into the renal replacement circuit and patients will be treated for up to 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose cohort | Experimental | Biological: SBI-101SBI-101 device containing 250 million MSCs |
| High dose cohort | Experimental | Biological: SBI-101SBI-101 device containing 750 million MSCs |
| Case controls | No intervention | –Case control subjects will receive only standard-of-care treatment and will be followed for the same safety assessments as active study participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Documented evidence of infection, e.g., positive PCR for COVID-19, positive blood cultures for systemic infection, active urinary sediment to suggest UTI, or any imaging supportive of a clinical diagnosis of infection, for example, pulmonary infiltrate on chest x-ray to suggest pneumonia, pancreatitis on CT imaging, abdominal collection, etc.
- AKI as determined by the Investigator based on his/her clinical judgment
- Receiving or planned to receive RRT in < 24 hours
- Able to tolerate indwelling intravascular access
- Has tolerated CRRT for at least 6 hours prior to IP treatment
Key exclusion criteria (21 listed)
- Female subjects who are pregnant, planning to become pregnant, or lactating
- MAP <70 mmHg immediately prior to IP initiation
- Systolic blood pressure < 90 mmHg immediately prior to IP initiation
- Mechanical ventilator support requiring FiO2 > 80% prior to IP initiation
- Receiving extracorporeal membrane oxygenation (ECMO)
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 |
|---|---|---|
| SBI-101SBI-101 is a biologic/device combination product that combines two components: allogeneic human mesenchymal stromal cells (MSCs) and an FDA-approved plasmapheresis device. SBI-101 is administered via integration into a Continuous Renal Replacement Therapy circuit and is designed to regulate inflammation and promote repair of injured tissue. | Biological | High dose cohort, Low dose cohort |
Primary outcome
Safety and tolerability as measured by incidence of IP-related serious adverse events
Time frame: Outcomes and Serious Adverse Events through Day 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 SBI-101 in people with COVID-19 and Acute Kidney Injury, run by Sentien Biotechnologies, 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 13 inclusion and 21 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 14 Jan 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. 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?
Results are not available in the source record.
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 and tolerability as measured by incidence of IP-related serious adverse events (time frame: Outcomes and Serious Adverse Events through Day 180). 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 14 Jan 2022.