Covid19Phase 1CoronaStem1NCT04486001
Study of Intravenous Administration of Allogeneic Adipose Stem Cells for COVID-19
A Phase 1 study testing PSC-04 in people with Covid19, run by Sorrento Therapeutics, Inc. at 1 site in United States.
Trial summary
This study is designed rapidly assess safety and preliminary efficacy in hospitalized patients with COVID-19 respiratory distress to provide clinical guidance for possible wider use in treating patients in this pandemic environment. This data will be used for FDA IND filings and pursuit of a BLA. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19
- What is being tested?
- PSC-04
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2020to 30 Aug 2021
- 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
- Admitted to hospital as in-patient (ward or ICU)
- Respiratory distress - respiratory rate ≥ 30/minute (or PaO2:FiO2 <300)
- Bilateral lung infiltrates (CT or frontal X-ray)
- Supplemental oxygen started but NOT intubated or ventilated
- COVID-19 (SARS-CoV-2) antigen test positive (FDA-approved test);
- CDC confirmation not necessary
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- Time from Enrollment to treatment must be less than 24 hours
- Age: 18-80 years
- Gender: any
- Suitability for cellular therapy: In the opinion of the Investigator or the Sponsor the patient is suitable for cellular therapy
- Cognitive function: Able to understand and willing to sign informed consent form or legally authorized representative or surrogate
Who cannot join
- Intubation / ventilation
- Current therapy is working, and patient is clinically improving
- Disease Conditions: Heart failure severe (NY Heart Association Classification IV); Clinical evidence of left heart failure or volume overload as a primary explanation for the bilateral pulmonary infiltrates; Any disease or condition other than current respiratory COVID-19 disease for which 6-month mortality is estimated to be greater than 50%; Moderate to severe liver failure; Severe chronic respiratory disease or the use of home oxygen use prior to this current illness; Currently receiving extracorporeal life support (ECLS/ECMO)
- Past Disease Conditions: Any history of malignancy within the last 2 years (except for patients in remission or cured of the malignancy); Lung transplant patient or lobectomy; Deep venous thrombosis or pulmonary embolism within past 3 months; History of splenectomy
- Other Experimental Conditions: Currently enrolled or treated in last 60 days in another clinical study
- Consent Issues: Do not resuscitate (DNR) order in place; Not willing to follow lung protective ventilation strategy, if needed
- Concurrent disease or circumstances that Investigator or Sponsor judges to be an unacceptable risk to patient health or a confounding variable to assessment or problem in completion of trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 Stem Cell Therapy: A Phase I Study of Intravenous Administration of Allogeneic Adipose Stem Cells
This study is designed rapidly assess safety and preliminary efficacy in hospitalized patients with COVID-19 respiratory distress to provide clinical guidance for possible wider use in treating patients in this pandemic environment. This data will be used for FDA IND filings and pursuit of a BLA.
Read the detailed description
This study is single arm, non-randomized Phase 1 study of the safety and preliminary efficacy of PSC-04, an adipose-derived allogeneic mesenchymal stem cell. The outcome data will be compared to contemporaneous non-enrolled patients at the same clinical site(s) as the enrolled patients.
Study Objectives:
Primary: To evaluate the safety of intravenous infusion of allogeneic adipose stem cells in patients with COVID-19 disease and respiratory distress.
Secondary: To evaluate a set of secondary safety and efficacy outcome variables to give guidance in assessing the risk/benefit ratio in patients with COVID-19 respiratory distress.
- Conditions
- Covid19
- Being tested
- PSC-04
- Keywords
- adipose, stem cell, COVID19, COVID-19, pneumonia
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSC-04Biological
Also called allogeneic, adipose-derived stem cells
adipose stem cells derived from screened donor lipoaspirate and culture expanded.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | This is single arm study with only comparison to non-treated cohorts at site. Receives: Biological: PSC-04 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of all adverse events
Frequency of all reported adverse events in study
Measured: Through study completion, an average of three months
Frequency of infusion related serious adverse events
Frequency of SAEs in the 6 hours post-infusion for each infusion
Measured: 6 hours post infusion
Frequency of serious adverse events
Frequency of all serious adverse events in study
Measured: Through study completion, an average of three months
Secondary outcomes (6)
Mortality
All-cause mortality through Day 28
Measured: Study days 0-28
Ventilator Free Days
Ventilator free days through Study day 28
Measured: Study days 0-28
ICU Free Days
Total days not in ICU from Study day 0 through Study day 28
Measured: Days 0 through 28
Total Hospital Days
Total Days in Hospital from Day 0 through discharge for survivors
Measured: Days 0 through discharge, an average of 28 days
Total ICU Days
Total Days in ICU from Day 0 through discharge for survivors
Measured: Days 0 through discharge, an average of 28 days
Improvement in Oxygenation
Improvement in oxygenation comparing Study day 0, to days 2, 4, 6
Measured: Study days 0, 2, 4, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start15 Dec 2020
- Primary completion9 Jun 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single group comparison with cohort of contemporaneous non-treated patients.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorrento Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VetStem Biopharma, Inc., Community Health System
- Responsible party
- Sponsor
- Investigators
- Mike Royal, MD JD, Study director, Sorrento Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486001
- Sponsor's protocol ID
- PSC-CP-004
- Acronym
- CoronaStem1
- Status last verified
- Mar 2022
- First submitted
- 22 Jul 2020
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rogers CJ, Harman RJ, Bunnell BA, Schreiber MA, Xiang C, Wang FS, Santidrian AF, Minev BR. Rationale for the clinical use of adipose-derived mesenchymal stem cells for COVID-19 patients. J Transl Med. 2020 May 18;18(1):203. doi: 10.1186/s12967-020-02380-2.
PubMed 32423449
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Stem Cell Therapy: A Phase I Study of Intravenous Administration of Allogeneic Adipose Stem Cells
- ClinicalTrials.gov ID
- NCT04486001
- Acronym / sponsor ID
- CoronaStem1 / PSC-CP-004
- Conditions
- Covid19
- Keywords
- adipose, stem cell, COVID19, COVID-19, pneumonia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- VetStem Biopharma, Inc., Community Health System
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 24 Jul 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.
This study is designed rapidly assess safety and preliminary efficacy in hospitalized patients with COVID-19 respiratory distress to provide clinical guidance for possible wider use in treating patients in this pandemic environment. This data will be used for FDA IND filings and pursuit of a BLA.
Detailed description
This study is single arm, non-randomized Phase 1 study of the safety and preliminary efficacy of PSC-04, an adipose-derived allogeneic mesenchymal stem cell. The outcome data will be compared to contemporaneous non-enrolled patients at the same clinical site(s) as the enrolled patients.
Study Objectives:
Primary: To evaluate the safety of intravenous infusion of allogeneic adipose stem cells in patients with COVID-19 disease and respiratory distress.
Secondary: To evaluate a set of secondary safety and efficacy outcome variables to give guidance in assessing the risk/benefit ratio in patients with COVID-19 respiratory distress.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group comparison with cohort of contemporaneous non-treated patients.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Biological: PSC-04This is single arm study with only comparison to non-treated cohorts at site. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Admitted to hospital as in-patient (ward or ICU)
- Respiratory distress - respiratory rate ≥ 30/minute (or PaO2:FiO2 <300)
- Bilateral lung infiltrates (CT or frontal X-ray)
- Supplemental oxygen started but NOT intubated or ventilated
- COVID-19 (SARS-CoV-2) antigen test positive (FDA-approved test);
Key exclusion criteria (7 listed)
- Intubation / ventilation
- Current therapy is working, and patient is clinically improving
- Disease Conditions: Heart failure severe (NY Heart Association Classification IV); Clinical evidence of left heart failure or volume overload as a primary explanation for the bilateral pulmonary infiltrates; Any disease or condition other than current respiratory COVID-19 disease for which 6-month mortality is estimated to be greater than 50%; Moderate to severe liver failure; Severe chronic respiratory disease or the use of home oxygen use prior to this current illness; Currently receiving extracorporeal life support (ECLS/ECMO)
- Past Disease Conditions: Any history of malignancy within the last 2 years (except for patients in remission or cured of the malignancy); Lung transplant patient or lobectomy; Deep venous thrombosis or pulmonary embolism within past 3 months; History of splenectomy
- Other Experimental Conditions: Currently enrolled or treated in last 60 days in another clinical study
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 |
|---|---|---|
| PSC-04Also: allogeneic, adipose-derived stem cellsadipose stem cells derived from screened donor lipoaspirate and culture expanded. | Biological | Treatment Group |
Primary outcome
Frequency of all adverse events
Time frame: Through study completion, an average of three months
Frequency of all reported adverse events in study
Frequency of infusion related serious adverse events
Time frame: 6 hours post infusion
Frequency of SAEs in the 6 hours post-infusion for each infusion
Frequency of serious adverse events
Time frame: Through study completion, an average of three months
Frequency of all serious adverse events in study
6 secondary outcomes
Mortality
Time frame: Study days 0-28
Ventilator Free Days
Time frame: Study days 0-28
ICU Free Days
Time frame: Days 0 through 28
Total Hospital Days
Time frame: Days 0 through discharge, an average of 28 days
Total ICU Days
Time frame: Days 0 through discharge, an average of 28 days
Improvement in Oxygenation
Time frame: Study days 0, 2, 4, 6
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 17 Mar 2022.
- Results publication: PubMed 32423449Rogers CJ, Harman RJ, Bunnell BA, Schreiber MA, Xiang C, Wang FS, Santidrian AF, Minev BR. Rationale for the clinical use of adipose-derived mesenchymal stem cells for COVID-19 patients. J Transl Med. 2020 May 18;18(1):203. doi: 10.1186/s12967-020-02380-2.
- 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.
Mike Royal, MD JD study director
Sorrento Therapeutics, Inc.
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 PSC-04 in people with Covid19, run by Sorrento Therapeutics, Inc. 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 11 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: finished, as of the sponsor's last update on 17 Mar 2022. 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 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?
Frequency of all adverse events (time frame: Through study completion, an average of three months). 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?
On the ClinicalTrials.gov record for NCT04486001, which also lists 1 linked publication.
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 17 Mar 2022.