Covid19Phase 1/2ARDOXSONCT04798716
The Use of Exosomes for the Treatment of Acute Respiratory Distress Syndrome or Novel Coronavirus Pneumonia Caused by COVID-19
A Phase 1/2 study testing MSC-exosomes delivered intravenously every other day on an escalating dose: (2:4:8), MSC-exosomes delivered intravenously every other day on an escalating dose (8:4:8) and MSC-exosomes delivered intravenously every other day (8:8:8) in people with Covid19 and Novel Coronavirus Pneumonia, run by AVEM HealthCare at 1 site in United States.
Trial summary
Novel coronavirus pneumonia (NCP) and acute respiratory distress syndrome (ARDS) are both associated with the prevailing upper respiratory tract infections caused by the RNA-containing SARS-CoV2 virus of the genius Betacoronavirus of the Coronaviridae family. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Novel Coronavirus Pneumonia, Acute Respiratory Distress Syndrome
- What is being tested?
- MSC-exosomes delivered intravenously every other day on an escalating dose: (2:4:8), MSC-exosomes delivered intravenously every other day on an escalating dose (8:4:8) and MSC-exosomes delivered intravenously every other day (8:8:8)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2023to Dec 2024
- 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
- Informed Consent given
- Male and female patients age 18 years or older
- Patients with coronavirus (SARS-CoV-2) infection confirmed prior to enrollment by any test with local regulatory approval
- Patients who require intensive care as determined by the following objective criteria:
- Respiratory rate>25/minute
- Oxygen saturation <93% on room air; or the
Show all 10Show fewer
- Use of high flow oxygen by nasal cannula at a rate ≥ 4L/minute.
- Patients with lung imaging demonstrating bilateral or diffuse pulmonary infiltrates on chest X-ray or CT scan.
- Patients with moderate to severe ARDS as defined by Berlin Criteria
- Patients who require invasive mechanical ventilation (IMV)
Who cannot join
- Patients will be excluded from the study if ONE of the following applies:
- History of hypersensitivity to any drugs of similar classes to exosomes
- Suspected active uncontrolled bacterial, fungal, or viral (besides SARS-CoV-2) infection
- Currently receiving ECMO, nitric oxide therapy, or high-frequency oscillatory ventilation
- In the option of the investigator, the patient is unlikely to survive for more than 24 hours post-enrollment
- Patients who are on long-term use of select oral or injectable anti-rejection or immunomodulatory drugs
- Pregnant or nursing (lacking) women
Trial locations and contacts
1 site in 1 country.
Sant P Chawla, MD contact
United States1 site
Mission Community Hospital
Panorama City, California, 91402
Sant P Chawla, MD
About this study
Official title: Mesenchymal Stem Cell Exosomes for the Treatment of COVID-19 Positive Patients With Acute Respiratory Distress Syndrome and/or Novel Coronavirus Pneumonia
Novel coronavirus pneumonia (NCP) and acute respiratory distress syndrome (ARDS) are both associated with the prevailing upper respiratory tract infections caused by the RNA-containing SARS-CoV2 virus of the genius Betacoronavirus of the Coronaviridae family. As both the viral infiltration and infection progress, the host immune system response can be one of a rapidly developing fatal cytokine storm. In the ARDS or NCP ensuing progression, the patient often succumbs to the effects of the hyper pro-inflammatory response, hence contributing to the associated increased mortality as a result of the cytokine storm and associated pathogenesis.
Read the detailed description
In December of 2019, in Wuhan, China, a novel coronavirus outbreak began. Globally this disease referred to as COVID-19, is the result of a novel SARS-CoV2 virus which predominantly targets Type II lung alveolar cells (AT2). The hyper response of the host immune system can rapidly evolve into a life-threatening cytokine-release syndrome or cytokine storm. The cytokine storm can predispose the patient to ARDS and/or NCP., or both. Left unchecked, the ARDS pathogenesis rapidly culminates in disruption of cell cytotoxicity mechanisms, excessive activation of cytotoxic lymphocytes, and a predominance of type I (M1) macrophage; resulting in the massive release of a host of proinflammatory cytokines (FNO-α, IL-1, IL-2, IL-6, IL-8, IL-10), granulocytic colony-stimulating factor, monocytic chemoattractive protein 1. The result systemically is a rise in surrogate inflammatory markers (C Reactive Protein, serum ferritin), with a corresponding infiltration of internal organs and tissues by activated macrophage, T-lymphocytes and a predominance of cellular apoptosis. The resulting hyperinflammatory pathogenic reaction may result in severe aveolar lesions leading to death, scarring, or severe lung damage, persisting well after discharge.
Experimental studies have demonstrated that mesenchymal stem cells (MSCs) and MSC-culutre media (MSC-CM) may significantly reduce the pro-inflammatory bias and associated pathologic impairment resulting. The MSC-CM, known to contain exosomes, has been shown to have an anti-inflammatory effect. Further exosomes associated with the amniotic membrane, long used in the treatment of burn and wounds, have been show to have a regenerative effect.
The purpose of this protocol is to explore the safety and efficacy of an intravenous injection of MSC derived exosomes in the treatment of severe patients (moderate to severe Berlin score) with ARDS or NCP.
- Being tested
- MSC-exosomes delivered intravenously every other day on an escalating dose: (2:4:8), MSC-exosomes delivered intravenously every other day on an escalating dose (8:4:8), MSC-exosomes delivered intravenously every other day (8:8:8)
- Keywords
- Novel Corona Virus Pneumonia, Exosomes, MSC, Acute Respiratory Distress Syndrome
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSC-exosomes delivered intravenously every other day on an escalating dose: (2:4:8)Drug
Also called Ardoxso
Escalating dose 2 X 10^9, 4 X 10^9, 8 X 10^9/mL
MSC-exosomes delivered intravenously every other day on an escalating dose (8:4:8)Drug
Also called Ardoxso
Escalating dose 8 X 10^9, 4 X 10^9, 8 X 10^9 mL
MSC-exosomes delivered intravenously every other day (8:8:8)Drug
Also called Ardoxso
Dosed 8 X 10^9, 8 X 10^9, 8 X 10^9 mL
| Study group | Role | What they receive |
|---|---|---|
| Escalating Dose First Cohort | Experimental | First Cohort:
Five patients will receive an escalating dose every other day for a period of 5 days, with a minimum of 24 hours between doses recorded. Dose escalation will begin at 2 x 10^9 exosomes Receives: Drug: MSC-exosomes delivered intravenously every other day on an escalating dose: (2:4:8) |
| Escalating Dose Second Cohort | Experimental | Second Cohort:
Five patients will receive an escalating dose every other day for a period of 5 days, with a minimum of 24 hours between doses recorded. Dose escalation will begin at 4 x 10^9 exosomes. Receives: Drug: MSC-exosomes delivered intravenously every other day on an escalating dose (8:4:8) |
| Escalating Dose Third Cohort | Experimental | Five patients will receive a treatment dose of 8 X 10^9 exosomes every other day for a period of 5 days, with a minimum of 24 hours between doses recorded. Receives: Drug: MSC-exosomes delivered intravenously every other day (8:8:8) |
| Treatment Dose Fourth Cohort Randomized control ratio 1:3 | Placebo comparator | Fourth Cohort:
Randomized Cohort Up to 40 patients may be enrolled in this phase of the trial. For those receiving the placebo (~25%), 3 doses will be given over the 5 day period, dispensed from identical vials with physician and patient blinded. The full dose of 8 X 10^9 exosomes will be given to 75% of the patients in 3 doses over the course of 5 days, with one dose occurring every other day. Receives: Drug: MSC-exosomes delivered intravenously every other day (8:8:8) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure and report the number of participants with treatment-related-adverse events as assessed by CTCAE v4.0; for patients receiving ARDOXSO™, perinatal MSC-derived exosome therapy.
Quantify safety of ARDOXSO™, an interventional exosome therapy in COVID-19 in participants confirmed with SARS-CoV-2 infection who receive ARDOXSO™ as an intervention.
Measured: 90 Days
Tabulate and report the number of IMV days for patients receiving ARDOXSO™ perinatal MSC-derived exosome therapy.
Quantify efficacy of ARDOXSO™, an interventional exosome therapy in COVID-19 in participants confirmed with SARS-CoV-2 infection who receive ARDOXSO™ as an intervention.
Measured: 90 Days
Secondary outcomes (2)
Analyze and report organ failure, associated with ICU mortality in participants confirmed with SARS-CoV2 infection, receiving ARDOXSO™ as an interventional exosome therapy.
Correlate and analyze the Sequential Organ Failure Assessment (SOFA) score in participants confirmed with SARS-CoV2 infection, receiving ARDOXSO™, an interventional exosome therapy in COVID-19 patients. An increased SOFA score is predictive of increased mortality.
Measured: 90 Days from last dose
Record and analyze respiratory measures (Berlin Score/PEEP) following treatment regime.
Berlin Score is a validated measure of Acute Respiratory Distress Syndrome diagnosis, which is common in COVID-19 patients, before and after receiving the interventional exosome therapy, ARDOXSO™.
Measured: 90 Days from last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study startSep 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Nested Cohort with Escalating Dose. The trial has three cohorts of 5 patients each. The subsequent cohort will receive an escalating dose of exosomes via intravenous infusion. The final group of 40 participants will be randomized 1:3 (placebo:intervention).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AVEM HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798716
- Sponsor's protocol ID
- 020582
- Acronym
- ARDOXSO
- Status last verified
- Mar 2022
- First submitted
- 12 Mar 2021
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Liang X, Zhang L, Wang S, Han Q, Zhao RC. Exosomes secreted by mesenchymal stem cells promote endothelial cell angiogenesis by transferring miR-125a. J Cell Sci. 2016 Jun 1;129(11):2182-9. doi: 10.1242/jcs.170373.
PubMed 27252357Leong DJ, Sun HB. Mesenchymal stem cells in tendon repair and regeneration: basic understanding and translational challenges. Ann N Y Acad Sci. 2016 Nov;1383(1):88-96. doi: 10.1111/nyas.13262. Epub 2016 Oct 5.
PubMed 27706825Zhang B, Yin Y, Lai RC, Tan SS, Choo AB, Lim SK. Mesenchymal stem cells secrete immunologically active exosomes. Stem Cells Dev. 2014 Jun 1;23(11):1233-44. doi: 10.1089/scd.2013.0479. Epub 2014 Feb 10.
PubMed 24367916Yang Y, Peng F, Wang R, Yang M, Guan K, Jiang T, Xu G, Sun J, Chang C. Corrigendum to "The deadly coronaviruses: The 2003 SARS pandemic and the 2020 novel coronavirus epidemic in China" [J. Autoimmun. 109C (2020) 102434]. J Autoimmun. 2020 Jul;111:102487. doi: 10.1016/j.jaut.2020.102487. Epub 2020 May 15. No abstract available.
PubMed 32423578Yang Y, Peng F, Wang R, Yange M, Guan K, Jiang T, Xu G, Sun J, Chang C. The deadly coronaviruses: The 2003 SARS pandemic and the 2020 novel coronavirus epidemic in China. J Autoimmun. 2020 May;109:102434. doi: 10.1016/j.jaut.2020.102434. Epub 2020 Mar 3.
PubMed 32143990Chien JY, Hsueh PR, Cheng WC, Yu CJ, Yang PC. Temporal changes in cytokine/chemokine profiles and pulmonary involvement in severe acute respiratory syndrome. Respirology. 2006 Nov;11(6):715-22. doi: 10.1111/j.1440-1843.2006.00942.x.
PubMed 17052299Wang CH, Liu CY, Wan YL, Chou CL, Huang KH, Lin HC, Lin SM, Lin TY, Chung KF, Kuo HP. Persistence of lung inflammation and lung cytokines with high-resolution CT abnormalities during recovery from SARS. Respir Res. 2005 May 11;6(1):42. doi: 10.1186/1465-9921-6-42.
PubMed 15888207Atri D, Siddiqi HK, Lang JP, Nauffal V, Morrow DA, Bohula EA. COVID-19 for the Cardiologist: Basic Virology, Epidemiology, Cardiac Manifestations, and Potential Therapeutic Strategies. JACC Basic Transl Sci. 2020 Apr 10;5(5):518-536. doi: 10.1016/j.jacbts.2020.04.002. eCollection 2020 May.
PubMed 32292848Ruan L, Wen M, Zeng Q, Chen C, Huang S, Yang S, Yang J, Wang J, Hu Y, Ding S, Zhang Y, Zhang H, Feng Y, Jin K, Zhuge Q. New Measures for the Coronavirus Disease 2019 Response: A Lesson From the Wenzhou Experience. Clin Infect Dis. 2020 Jul 28;71(15):866-869. doi: 10.1093/cid/ciaa386.
PubMed 32246149Ruan Q, Yang K, Wang W, Jiang L, Song J. Correction to: Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 Jun;46(6):1294-1297. doi: 10.1007/s00134-020-06028-z.
PubMed 32253449Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.
PubMed 32125452Munford RS, Pugin J. Normal responses to injury prevent systemic inflammation and can be immunosuppressive. Am J Respir Crit Care Med. 2001 Feb;163(2):316-21. doi: 10.1164/ajrccm.163.2.2007102. No abstract available.
PubMed 11179099Liu A, Zhang X, He H, Zhou L, Naito Y, Sugita S, Lee JW. Therapeutic potential of mesenchymal stem/stromal cell-derived secretome and vesicles for lung injury and disease. Expert Opin Biol Ther. 2020 Feb;20(2):125-140. doi: 10.1080/14712598.2020.1689954. Epub 2019 Nov 18.
PubMed 31701782Tu YF, Chien CS, Yarmishyn AA, Lin YY, Luo YH, Lin YT, Lai WY, Yang DM, Chou SJ, Yang YP, Wang ML, Chiou SH. A Review of SARS-CoV-2 and the Ongoing Clinical Trials. Int J Mol Sci. 2020 Apr 10;21(7):2657. doi: 10.3390/ijms21072657.
PubMed 32290293Chiappelli F, Khakshooy A, Greenberg G. CoViD-19 Immunopathology and Immunotherapy. Bioinformation. 2020 Mar 31;16(3):219-222. doi: 10.6026/97320630016219. eCollection 2020.
PubMed 32308263
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stem Cell Exosomes for the Treatment of COVID-19 Positive Patients With Acute Respiratory Distress Syndrome and/or Novel Coronavirus Pneumonia
- ClinicalTrials.gov ID
- NCT04798716
- Acronym / sponsor ID
- ARDOXSO / 020582
- Keywords
- Novel Corona Virus Pneumonia, Exosomes, MSC, Acute Respiratory Distress Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- AVEM HealthCareIndustry (pharma, biotech, devices)
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 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.
Novel coronavirus pneumonia (NCP) and acute respiratory distress syndrome (ARDS) are both associated with the prevailing upper respiratory tract infections caused by the RNA-containing SARS-CoV2 virus of the genius Betacoronavirus of the Coronaviridae family. As both the viral infiltration and infection progress, the host immune system response can be one of a rapidly developing fatal cytokine storm. In the ARDS or NCP ensuing progression, the patient often succumbs to the effects of the hyper pro-inflammatory response, hence contributing to the associated increased mortality as a result of the cytokine storm and associated pathogenesis.
Detailed description
In December of 2019, in Wuhan, China, a novel coronavirus outbreak began. Globally this disease referred to as COVID-19, is the result of a novel SARS-CoV2 virus which predominantly targets Type II lung alveolar cells (AT2). The hyper response of the host immune system can rapidly evolve into a life-threatening cytokine-release syndrome or cytokine storm. The cytokine storm can predispose the patient to ARDS and/or NCP., or both. Left unchecked, the ARDS pathogenesis rapidly culminates in disruption of cell cytotoxicity mechanisms, excessive activation of cytotoxic lymphocytes, and a predominance of type I (M1) macrophage; resulting in the massive release of a host of proinflammatory cytokines (FNO-α, IL-1, IL-2, IL-6, IL-8, IL-10), granulocytic colony-stimulating factor, monocytic chemoattractive protein 1. The result systemically is a rise in surrogate inflammatory markers (C Reactive Protein, serum ferritin), with a corresponding infiltration of internal organs and tissues by activated macrophage, T-lymphocytes and a predominance of cellular apoptosis. The resulting hyperinflammatory pathogenic reaction may result in severe aveolar lesions leading to death, scarring, or severe lung damage, persisting well after discharge.
Experimental studies have demonstrated that mesenchymal stem cells (MSCs) and MSC-culutre media (MSC-CM) may significantly reduce the pro-inflammatory bias and associated pathologic impairment resulting. The MSC-CM, known to contain exosomes, has been shown to have an anti-inflammatory effect. Further exosomes associated with the amniotic membrane, long used in the treatment of burn and wounds, have been show to have a regenerative effect.
The purpose of this protocol is to explore the safety and efficacy of an intravenous injection of MSC derived exosomes in the treatment of severe patients (moderate to severe Berlin score) with ARDS or NCP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- Nested Cohort with Escalating Dose. The trial has three cohorts of 5 patients each. The subsequent cohort will receive an escalating dose of exosomes via intravenous infusion. The final group of 40 participants will be randomized 1:3 (placebo:intervention).
| Arm | Type | Receives |
|---|---|---|
| Escalating Dose First Cohort | Experimental | Drug: MSC-exosomes delivered intravenously every other day on an escalating dose: (2:4:8)First Cohort: Five patients will receive an escalating dose every other day for a period of 5 days, with a minimum of 24 hours between doses recorded. Dose escalation will begin at 2 x 10^9 exosomes |
| Escalating Dose Second Cohort | Experimental | Drug: MSC-exosomes delivered intravenously every other day on an escalating dose (8:4:8)Second Cohort: Five patients will receive an escalating dose every other day for a period of 5 days, with a minimum of 24 hours between doses recorded. Dose escalation will begin at 4 x 10^9 exosomes. |
| Escalating Dose Third Cohort | Experimental | Drug: MSC-exosomes delivered intravenously every other day (8:8:8)Five patients will receive a treatment dose of 8 X 10^9 exosomes every other day for a period of 5 days, with a minimum of 24 hours between doses recorded. |
| Treatment Dose Fourth Cohort Randomized control ratio 1:3 | Placebo comparator | Drug: MSC-exosomes delivered intravenously every other day (8:8:8)Fourth Cohort: Randomized Cohort Up to 40 patients may be enrolled in this phase of the trial. For those receiving the placebo (~25%), 3 doses will be given over the 5 day period, dispensed from identical vials with physician and patient blinded. The full dose of 8 X 10^9 exosomes will be given to 75% of the patients in 3 doses over the course of 5 days, with one dose occurring every other day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Informed Consent given
- Male and female patients age 18 years or older
- Patients with coronavirus (SARS-CoV-2) infection confirmed prior to enrollment by any test with local regulatory approval
- Patients who require intensive care as determined by the following objective criteria:
- Patients with lung imaging demonstrating bilateral or diffuse pulmonary infiltrates on chest X-ray or CT scan.
Key exclusion criteria (7 listed)
- Patients will be excluded from the study if ONE of the following applies:
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 |
|---|---|---|
| MSC-exosomes delivered intravenously every other day on an escalating dose: (2:4:8)Also: ArdoxsoEscalating dose 2 X 10^9, 4 X 10^9, 8 X 10^9/mL | Drug | Escalating Dose First Cohort |
| MSC-exosomes delivered intravenously every other day on an escalating dose (8:4:8)Also: ArdoxsoEscalating dose 8 X 10^9, 4 X 10^9, 8 X 10^9 mL | Drug | Escalating Dose Second Cohort |
| MSC-exosomes delivered intravenously every other day (8:8:8)Also: ArdoxsoDosed 8 X 10^9, 8 X 10^9, 8 X 10^9 mL | Drug | Escalating Dose Third Cohort, Treatment Dose Fourth Cohort Randomized control ratio 1:3 |
Primary outcome
Measure and report the number of participants with treatment-related-adverse events as assessed by CTCAE v4.0; for patients receiving ARDOXSO™, perinatal MSC-derived exosome therapy.
Time frame: 90 Days
Quantify safety of ARDOXSO™, an interventional exosome therapy in COVID-19 in participants confirmed with SARS-CoV-2 infection who receive ARDOXSO™ as an intervention.
Tabulate and report the number of IMV days for patients receiving ARDOXSO™ perinatal MSC-derived exosome therapy.
Time frame: 90 Days
Quantify efficacy of ARDOXSO™, an interventional exosome therapy in COVID-19 in participants confirmed with SARS-CoV-2 infection who receive ARDOXSO™ as an intervention.
2 secondary outcomes
Analyze and report organ failure, associated with ICU mortality in participants confirmed with SARS-CoV2 infection, receiving ARDOXSO™ as an interventional exosome therapy.
Time frame: 90 Days from last dose
Record and analyze respiratory measures (Berlin Score/PEEP) following treatment regime.
Time frame: 90 Days from last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Background: PubMed 27252357Liang X, Zhang L, Wang S, Han Q, Zhao RC. Exosomes secreted by mesenchymal stem cells promote endothelial cell angiogenesis by transferring miR-125a. J Cell Sci. 2016 Jun 1;129(11):2182-9. doi: 10.1242/jcs.170373.
- Background: PubMed 27706825Leong DJ, Sun HB. Mesenchymal stem cells in tendon repair and regeneration: basic understanding and translational challenges. Ann N Y Acad Sci. 2016 Nov;1383(1):88-96. doi: 10.1111/nyas.13262. Epub 2016 Oct 5.
- Background: PubMed 24367916Zhang B, Yin Y, Lai RC, Tan SS, Choo AB, Lim SK. Mesenchymal stem cells secrete immunologically active exosomes. Stem Cells Dev. 2014 Jun 1;23(11):1233-44. doi: 10.1089/scd.2013.0479. Epub 2014 Feb 10.
- Background: PubMed 32423578Yang Y, Peng F, Wang R, Yang M, Guan K, Jiang T, Xu G, Sun J, Chang C. Corrigendum to "The deadly coronaviruses: The 2003 SARS pandemic and the 2020 novel coronavirus epidemic in China" [J. Autoimmun. 109C (2020) 102434]. J Autoimmun. 2020 Jul;111:102487. doi: 10.1016/j.jaut.2020.102487. Epub 2020 May 15. No abstract available.
- Background: PubMed 32143990Yang Y, Peng F, Wang R, Yange M, Guan K, Jiang T, Xu G, Sun J, Chang C. The deadly coronaviruses: The 2003 SARS pandemic and the 2020 novel coronavirus epidemic in China. J Autoimmun. 2020 May;109:102434. doi: 10.1016/j.jaut.2020.102434. Epub 2020 Mar 3.
- Background: PubMed 17052299Chien JY, Hsueh PR, Cheng WC, Yu CJ, Yang PC. Temporal changes in cytokine/chemokine profiles and pulmonary involvement in severe acute respiratory syndrome. Respirology. 2006 Nov;11(6):715-22. doi: 10.1111/j.1440-1843.2006.00942.x.
- Background: PubMed 15888207Wang CH, Liu CY, Wan YL, Chou CL, Huang KH, Lin HC, Lin SM, Lin TY, Chung KF, Kuo HP. Persistence of lung inflammation and lung cytokines with high-resolution CT abnormalities during recovery from SARS. Respir Res. 2005 May 11;6(1):42. doi: 10.1186/1465-9921-6-42.
- Background: PubMed 32292848Atri D, Siddiqi HK, Lang JP, Nauffal V, Morrow DA, Bohula EA. COVID-19 for the Cardiologist: Basic Virology, Epidemiology, Cardiac Manifestations, and Potential Therapeutic Strategies. JACC Basic Transl Sci. 2020 Apr 10;5(5):518-536. doi: 10.1016/j.jacbts.2020.04.002. eCollection 2020 May.
- Background: PubMed 32246149Ruan L, Wen M, Zeng Q, Chen C, Huang S, Yang S, Yang J, Wang J, Hu Y, Ding S, Zhang Y, Zhang H, Feng Y, Jin K, Zhuge Q. New Measures for the Coronavirus Disease 2019 Response: A Lesson From the Wenzhou Experience. Clin Infect Dis. 2020 Jul 28;71(15):866-869. doi: 10.1093/cid/ciaa386.
- Background: PubMed 32253449Ruan Q, Yang K, Wang W, Jiang L, Song J. Correction to: Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 Jun;46(6):1294-1297. doi: 10.1007/s00134-020-06028-z.
- Background: PubMed 32125452Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.
- Background: PubMed 11179099Munford RS, Pugin J. Normal responses to injury prevent systemic inflammation and can be immunosuppressive. Am J Respir Crit Care Med. 2001 Feb;163(2):316-21. doi: 10.1164/ajrccm.163.2.2007102. No abstract available.
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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.
Sant P Chawla, MD contact
1 site 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 MSC-exosomes delivered intravenously every other day on an escalating dose: (2:4:8), MSC-exosomes delivered intravenously every other day on an escalating dose (8:4:8) and MSC-exosomes delivered intravenously every other day (8:8:8) in people with Covid19 and Novel Coronavirus Pneumonia, run by AVEM HealthCare 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 10 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 11 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. 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 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?
Contact Tammy C Luttrell, PhD (833-957-0079, tammy.luttrell@avemhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure and report the number of participants with treatment-related-adverse events as assessed by CTCAE v4.0; for patients receiving ARDOXSO™, perinatal MSC-derived exosome therapy. (time frame: 90 Days). The study lists 2 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 NCT04798716, which also lists 18 linked publications.
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 11 Mar 2022.