The Use of Exosomes for the Treatment of Acute Respiratory Distress Syndrome or Novel Coronavirus Pneumonia Caused by COVID-19
NCT ID: NCT04798716
Last Updated: 2022-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
55 participants
INTERVENTIONAL
2023-09-30
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
The final 40 participants are included in RCT. Double; participant and physician are masked.
Study Groups
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Escalating Dose First Cohort
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
MSC-exosomes delivered intravenously every other day on an escalating dose: (2:4:8)
Escalating dose 2 X 10\^9, 4 X 10\^9, 8 X 10\^9/mL
Escalating Dose Second Cohort
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.
MSC-exosomes delivered intravenously every other day on an escalating dose (8:4:8)
Escalating dose 8 X 10\^9, 4 X 10\^9, 8 X 10\^9 mL
Escalating Dose Third Cohort
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.
MSC-exosomes delivered intravenously every other day (8:8:8)
Dosed 8 X 10\^9, 8 X 10\^9, 8 X 10\^9 mL
Treatment Dose Fourth Cohort Randomized control ratio 1:3
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.
MSC-exosomes delivered intravenously every other day (8:8:8)
Dosed 8 X 10\^9, 8 X 10\^9, 8 X 10\^9 mL
Interventions
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MSC-exosomes delivered intravenously every other day on an escalating dose: (2:4:8)
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)
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)
Dosed 8 X 10\^9, 8 X 10\^9, 8 X 10\^9 mL
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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AVEM HealthCare
INDUSTRY
Responsible Party
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Locations
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Mission Community Hospital
Panorama City, California, United States
Countries
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Central Contacts
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Facility Contacts
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Sant P Chawla, MD
Role: primary
References
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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.
Leong 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.
Zhang 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.
Yang 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.
Yang 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.
Chien 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.
Wang 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.
Atri 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.
Ruan 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.
Ruan 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.
Ruan 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.
Munford 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.
Liu 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.
Tu 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.
Chiappelli F, Khakshooy A, Greenberg G. CoViD-19 Immunopathology and Immunotherapy. Bioinformation. 2020 Mar 31;16(3):219-222. doi: 10.6026/97320630016219. eCollection 2020.
Ringden O, Le Blanc K. Mesenchymal stem cells for treatment of acute and chronic graft-versus-host disease, tissue toxicity and hemorrhages. Best Pract Res Clin Haematol. 2011 Mar;24(1):65-72. doi: 10.1016/j.beha.2011.01.003. Epub 2011 Feb 25.
Chang YS, Choi SJ, Ahn SY, Sung DK, Sung SI, Yoo HS, Oh WI, Park WS. Timing of umbilical cord blood derived mesenchymal stem cells transplantation determines therapeutic efficacy in the neonatal hyperoxic lung injury. PLoS One. 2013;8(1):e52419. doi: 10.1371/journal.pone.0052419. Epub 2013 Jan 21.
Gao Y, Sun J, Dong C, Zhao M, Hu Y, Jin F. Extracellular Vesicles Derived from Adipose Mesenchymal Stem Cells Alleviate PM2.5-Induced Lung Injury and Pulmonary Fibrosis. Med Sci Monit. 2020 Apr 18;26:e922782. doi: 10.12659/MSM.922782.
Other Identifiers
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020582
Identifier Type: -
Identifier Source: org_study_id
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