Corona Virus InfectionPhase 2AdMSCsNCT05017298
Clinical Study for Subjects With COVID-19 Using Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells
A Phase 2 study testing Allogeneic adipose-derived stem cells in people with Corona Virus Infection and Covid19, run by Celltex Therapeutics Corporation.
Trial summary
This is an interventional new drug clinical trial for a Phase 2 randomized, double-blind, and placebo control study using intravenous injection of allogeneic adipose stem cells (Celltex AdMSCs) for subjects with severe COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corona Virus Infection, Covid19
- What is being tested?
- Allogeneic adipose-derived stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 15 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age above 18 years.
- Male and female
- Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures
- Diagnosed as COVID-19 based upon SARS-CoV-2 RT-PCR test positive
- Clinical diagnosis meets severe and/or critical parameters
- Male participants must be willing to ensure their partners do not become pregnant either by practicing abstinence or the use of condoms during sexual activity
Who cannot join
- Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start
- Unwillingness or inability to comply with study procedures
- Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc.
- Clinically active malignant disease
- Subjects who are receiving ECMO and CRRT currently
- History of known pulmonary embolism or known secondary anti-phospholipid syndrome
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- Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g. BSA and sulfur containing products (e.g., DMSO)
- Known or suspected allergic to diphenhydramine.
- Major trauma or surgery within 14 days of study treatment start
- Mental condition rendering the subject (or the subject's legally acceptable representative[s]) unable to understand the nature, scope and possible consequences of the study
- Alcohol, drug, or medication abuse within one year prior to study treatment start
- Any condition that, in the Investigator's opinion, is likely to interfere with evaluation of the AdMSC therapy or satisfactory conduct of the study
- Irreversible severe end organ failure, such as heart failure/attack, stroke, liver and renal failure due to other disease conditions
- Patients or family history with hypercoagulable status, such as protein C/protein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.
- History of long-term use of immunosuppressive agents
- Organ transplants in the past 6 months
- Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth control during participation in the study duration, unless surgically sterilized or postmenopausal during the study.
- Patients with previous pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia before COVID-19 infection. The pulmonary imaging revealed the interstitial damage of lungs before the COVID-19 confirmed.
- QT interval shows greater than 450 ms in males and 470 ms in females in the medical histories or during screen EKG test.
- Subjects are not medically unstable at time of infusion including but not limiting unstable hypertension, pulse, oximetry, etc.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Study for Subjects With Coronavirus 2019 (COVID-19) Using Multiple Dose Intravenous Infusions of Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)
This is an interventional new drug clinical trial for a Phase 2 randomized, double-blind, and placebo control study using intravenous injection of allogeneic adipose stem cells (Celltex AdMSCs) for subjects with severe COVID-19.
- Conditions
- Corona Virus Infection, Covid19
- Being tested
- Allogeneic adipose-derived stem cells
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic adipose-derived stem cellsBiological
Also called Celltex-AdMSCs
Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Each subject receives three separate doses of 200 million allogeneic adipose-derived mesenchymal stem cells via intravenously infusion on days 0, 3, and 6 with a total of 600 million AdMSCs during 7 days in addition to their standard of care. Receives: Biological: Allogeneic adipose-derived stem cells |
| Control Group | Placebo comparator | The control group will receive placebo infusion on day 0, 3 and 6 along with standard of care. Receives: Biological: Allogeneic adipose-derived stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of AdMSC injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study based on the rate of all AdMSC-associated adverse events (AEs) in all subjects.
Incidence of treatment-related adverse events and severe adverse events during the study period
Measured: 6 months
Safety for AdMSCs based upon incidence of all AEs
Grouped by Medical Dictionary for Regulatory Activities (MedDRA)
Measured: 6 months
Compare the mortality rate
AdMSC treating group vs. control group
Measured: 6 months
Secondary outcomes (9)
Recognized immune measurements evaluating patients' symptom changes and overall function
To evaluate change of sequential organ failure assessment (SOFA) score as compare to the baseline
Measured: 6 months
Organ functional tests including blood specific enzymes and proteins
To evaluate the efficacy of allogeneic AdMSCs for COVID-19
Measured: 6 months
Duration (days) of weaning from mechanical ventilation
Compared to control group
Measured: 6 months
Duration (days) of ICU monitoring
Compared to control group
Measured: 6 months
Duration (days) of vasoactive agent's usage
Compared to control group
Measured: 6 months
Duration of hospitalization (days)
Compared to control group
Measured: 6 months
Proportions of SARS-CoV-2 RT-PCR change to negative from respiratory tract specimens (oropharyngeal swabs) using CDC standard method
Compared to control group
Measured: 6 months
Proportions of quantifying viral RNA in stool change to negative in final follow-up using CDC standard method
Compared to control group
Measured: 6 months
Proportions of blood SARS-CoV-2 antibodies IgM/IgG show positive
Compared to control group
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies 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
- Model description
- The Phase 2 study is a randomized, double blind and placebo control study conducted initially in a single clinic facility.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celltex Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Derek W Guillory, MD, Principal investigator, Root Causes Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017298
- Sponsor's protocol ID
- CTX0020-004
- Acronym
- AdMSCs
- Status last verified
- Apr 2023
- First submitted
- 18 Aug 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for Subjects With Coronavirus 2019 (COVID-19) Using Multiple Dose Intravenous Infusions of Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)
- ClinicalTrials.gov ID
- NCT05017298
- Acronym / sponsor ID
- AdMSCs / CTX0020-004
- Conditions
- Corona Virus Infection, Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Celltex Therapeutics CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 23 Aug 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 an interventional new drug clinical trial for a Phase 2 randomized, double-blind, and placebo control study using intravenous injection of allogeneic adipose stem cells (Celltex AdMSCs) for subjects with severe COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The Phase 2 study is a randomized, double blind and placebo control study conducted initially in a single clinic facility.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Biological: Allogeneic adipose-derived stem cellsEach subject receives three separate doses of 200 million allogeneic adipose-derived mesenchymal stem cells via intravenously infusion on days 0, 3, and 6 with a total of 600 million AdMSCs during 7 days in addition to their standard of care. |
| Control Group | Placebo comparator | Biological: Allogeneic adipose-derived stem cellsThe control group will receive placebo infusion on day 0, 3 and 6 along with standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age above 18 years.
- Male and female
- Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures
- Diagnosed as COVID-19 based upon SARS-CoV-2 RT-PCR test positive
- Clinical diagnosis meets severe and/or critical parameters
Key exclusion criteria (20 listed)
- Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start
- Unwillingness or inability to comply with study procedures
- Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc.
- Clinically active malignant disease
- Subjects who are receiving ECMO and CRRT currently
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 adipose-derived stem cellsAlso: Celltex-AdMSCsCulture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue | Biological | Control Group, Study Group |
Primary outcome
Safety of AdMSC injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study based on the rate of all AdMSC-associated adverse events (AEs) in all subjects.
Time frame: 6 months
Incidence of treatment-related adverse events and severe adverse events during the study period
Safety for AdMSCs based upon incidence of all AEs
Time frame: 6 months
Grouped by Medical Dictionary for Regulatory Activities (MedDRA)
Compare the mortality rate
Time frame: 6 months
AdMSC treating group vs. control group
9 secondary outcomes
Recognized immune measurements evaluating patients' symptom changes and overall function
Time frame: 6 months
Organ functional tests including blood specific enzymes and proteins
Time frame: 6 months
Duration (days) of weaning from mechanical ventilation
Time frame: 6 months
Duration (days) of ICU monitoring
Time frame: 6 months
Duration (days) of vasoactive agent's usage
Time frame: 6 months
Duration of hospitalization (days)
Time frame: 6 months
Proportions of SARS-CoV-2 RT-PCR change to negative from respiratory tract specimens (oropharyngeal swabs) using CDC standard method
Time frame: 6 months
Proportions of quantifying viral RNA in stool change to negative in final follow-up using CDC standard method
Time frame: 6 months
Proportions of blood SARS-CoV-2 antibodies IgM/IgG show positive
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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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.
Derek W Guillory, MD principal investigator
Root Causes Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allogeneic adipose-derived stem cells in people with Corona Virus Infection and Covid19, run by Celltex Therapeutics Corporation.
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 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: opening soon, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jane Young, Ph.D. (7135901000, jyoung@celltexbank.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of AdMSC injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study based on the rate of all AdMSC-associated adverse events (AEs) in all subjects. (time frame: 6 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?
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 7 Feb 2024.