MSC-exosomes delivered intravenously every other day on an escalating dose (8:4:8) for COVID-19

Phase-Based Estimates
1
Effectiveness
1
Safety
Mission Community Hospital, Panorama City, CA
COVID-19+9 More
MSC-exosomes delivered intravenously every other day on an escalating dose (8:4:8) - Drug
Eligibility
18+
All Sexes
Eligible conditions
COVID-19

Study Summary

This study is evaluating whether a drug may help reduce inflammation and improve outcomes for individuals with novel coronavirus pneumonia.

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Eligible Conditions

  • COVID-19
  • Acute Lung Injury
  • Pneumonia
  • Respiratory Distress Syndrome, Newborn
  • Coronavirus Infections
  • Respiratory Distress Syndrome
  • Syndrome
  • Covid19
  • Novel Coronavirus Pneumonia
  • Respiratory Distress Syndrome, Acute (ARDS)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether MSC-exosomes delivered intravenously every other day on an escalating dose (8:4:8) will improve 2 primary outcomes and 2 secondary outcomes in patients with COVID-19. Measurement will happen over the course of 90 Days from last dose.

90 Days
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.
Tabulate and report the number of IMV days for patients receiving ARDOXSO™ perinatal MSC-derived exosome therapy.
Day 90
Analyze and report organ failure, associated with ICU mortality in participants confirmed with SARS-CoV2 infection, receiving ARDOXSO™ as an interventional exosome therapy.
Record and analyze respiratory measures (Berlin Score/PEEP) following treatment regime.

Trial Safety

Safety Estimate

1 of 3

Trial Design

4 Treatment Groups

Treatment Dose Fourth Cohort Randomized control ratio 1:3
Escalating Dose Third Cohort
Placebo group

This trial requires 55 total participants across 4 different treatment groups

This trial involves 4 different treatments. MSC-exosomes Delivered Intravenously Every Other Day On An Escalating Dose (8:4:8) is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Escalating Dose Third Cohort
Drug
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.
Escalating Dose Second Cohort
Drug
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 First Cohort
Drug
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
Treatment Dose Fourth Cohort Randomized control ratio 1:3
Drug
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 90 days for reporting.

Closest Location

Mission Community Hospital - Panorama City, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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
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)

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes covid-19?

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Our analysis in Wuhan suggests that the virus has become more common and widespread in the area than previously estimated. On this basis, it may be important to monitor the spread of the disease, and to consider a range of potential explanations for its appearance and occurrence.

Unverified Answer

Can covid-19 be cured?

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Covid is not a 'cure' but the disease has an impact on the health and wellbeing of individuals and societies. Current global and national efforts need to focus on maintaining quality of care and reducing the burden of the disease.

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What are common treatments for covid-19?

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The treatment of COVID-19-positive individuals should be based on the severity of the symptoms and the possibility of serious complications. The most common treatment measures are aimed at reducing the symptoms and protecting the respiratory system. The possibility of cure must be kept in mind.

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How many people get covid-19 a year in the United States?

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About 13% of New York's adult population were infected by February 24. People are at risk if they are exposed to infected persons. People with known comorbidities are at greater risk of acquiring COVID-19. In terms of age groups, more than 1 in 10 adults and children had been exposed to others with COVID-19 by February 24. In New York City, with its high rate of case transmission and widespread prevalence, most adults have been exposed to others with COVID-19.

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What are the signs of covid-19?

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Signs of covid-19 include: fever, muscle or joint pains, muscle aches, runny nose, cough, shortness of breath, dry cough, and other respiratory symptoms such as shortness of breath, cough, chest pain, and chest discomfort.\n

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What is covid-19?

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Covid-19, commonly referred to as coronavirus (COVID-19), is a viral infection, specifically related to SARS-CoV-2, similar to SARS. The COVID-19 virus was initially identified in Wuhan, China, in December 2019, when SARS-CoV had been previously identified.\n

Unverified Answer

Does msc-exosomes delivered intravenously every other day on an escalating dose: (2:4:8) improve quality of life for those with covid-19?

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Intravenous MSC-Exo therapy (1x/m/d (2:4:8) does not improve QOL or survival for patients in this retrospective study. Due to the lack of a safety assessment and the complexity of delivering MSC-Exo therapy as an 'on demand' infusion, the question of if 1x/m/d MSC-Exo therapy is a reasonable option will be revisited in a prospective clinical trial.

Unverified Answer

What does msc-exosomes delivered intravenously every other day on an escalating dose: (2:4:8) usually treat?

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In a recent study, findings reveal that in comparison with a placebo treatment, treatment with Msc-Exo after EVD is highly efficient in a rabbit model of severe acute pancreatitis. This suggests that Msc-Exo, as originally applied, could be a new standard of care for acute severe pancreatitis and in particular for a life-threatening EVD by intravenous injection. However, more studies are needed to validate our observations and to clarify the mechanisms driving the amylase-neutralizing and anticancer actions and the effects of Msc-Exo on clinical outcomes and immunomodulation.

Unverified Answer

How serious can covid-19 be?

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[About 2% of all hospitalized patients in Italy acquire the disease during the course of the 2019-20 coronavirus outbreak, resulting in a median of 5 days of systemic corticosteroids use in the ICU (95% CI, 3.-7.7; P = 0.006) and an increased hospital readmission rate at a 1-month follow-up (11.0% vs. 4.4%; P = 0.002)](https://gadgets.ncbi.nlm/pages/genetics/lifebiology/gadgets/drosophila.

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Does covid-19 run in families?

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Recent findings indicates a strong family clustering of symptomatic HCOV infections, suggesting the possibility of a viral transmission in families, which may be influenced by genetic, behavioural, socioeconomic and genetic factors.

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Is msc-exosomes delivered intravenously every other day on an escalating dose: (2:4:8) safe for people?

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These dosing schemes were well tolerated and safely administered over several months. We conclude that (2:4:8) MSC-Exo dosing is safe and well tolerated in the pre-hospital setting and warrants further investigation to increase the number of patients eligible for this dosing strategy.

Unverified Answer

Who should consider clinical trials for covid-19?

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Patients who had a positive test for SARS, MERS or BSL, or who had had viral exposure within the span of the last year as well as those who had any exposure to non-physicians were at the highest risk for developing SARS or MERS to COVID-19. This information may help to identify patients most in need of antivirals for the prevention of SARS and MERS infections.

Unverified Answer
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Get access to this novel treatment for COVID-19 by sharing your contact details with the study coordinator.