Respiratory Failure Death - COVID-19 - A Novel Approach to ARDS

Exosome Therapies for Acute Respiratory Distress Syndrome

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COVID-19 Vs. Leading Causes of Death in the USA

COVID-19 SARS Virus (SARS-CoV-2) Outbreak USA VS Leading Causes of Death USA April 25, 2020 | SARS Virus SARS-CoV-2

April 24, 2020 – 4:31 PM ET COVID-19 Deaths Vs. Annual Leading Causes of Death USA

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DISCLAIMER: The information below is for educational purposes only. It does not constitute medical advice. It is not intended to diagnose, treat or cure any health-related condition. Please always consult a physician regarding your health. No medical treatment can guarantee results. Results may vary among individuals. We encourage you to do your own research, ask questions, and review this page with your doctor in an effort to exchange ideas which may offer solutions sooner rather than later.  Mesenchymal Stem Cells and Exosomes have been widely tested in animal and human models. We also make note of the FDA Public Safety Notification on Exosome Products below

Exosomes are extracellular vesicles that have been shown to help with tissue regeneration. The main mode of action is enhancing the natural regenerative healing capacity diminished by age and age-related chronic diseases.

Originally it was believed that injection of mesenchymal stem cells influenced regenerative tissue activity after they engrafted into the damaged tissue. More recently it has been observed that exosomes (the extra-cellular vesicles that surround stem cells) do much of the molecular intra-cellular communications between cell tissues to modulate regenerative activity.

Key therapeutic effects from MSC derived exosomes include:

  1. Regenerative growth of new cells
  2. Promoting regeneration
  3. Immunomodulation
  4. Anti-inflammatory effects
  5. Anti-fibrotic effects
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Note: Some information on this page has been curated from research available independently on YouTube, JAMA, NIH, and from other sources we consider highly credible. 

[Ref: FDA Public Safety Notification on Exosome Products]

We believe there is promising research on Stem Cell Therapies and Stem Cell-derived Exosome therapies in humans with ARDS. 

We also believe there are GMP standard labs registered with the FDA available now who are capable of producing these products safely. 

Our intent is to encourage brainstorming and look at the natural ability of stem cells and stem cell-derived exosomes’ paracrine benefits, in combination with standard of care therapies for acute lung injury and acute respiratory distress syndrome. These diseases may cause nearly 75,000 deaths annually before we encountered the coronavirus outbreak. 

We don’t suggest to offer exosomes in patients willy-nilly, but we must look at the research already done, and connect the dots. 

Why Death Occurs from COVID-19.

Deaths caused by COVID-19 are more generally due to respiratory failure - Acute Respiratory Distress Syndrome (ARDS)

ARDS is the main cause of death related to respiratory injury from infections and trauma. Acute respiratory distress syndrome (ARDS) affects nearly 200,000 patients each year in the USA. 

JAMA estimates nearly 75,000 deaths annually occur from ARDS in the United States. The death rate could increase dramatically due to the COVID-19 outbreak.

We believe more work can be done on improving outcomes by treating acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) using MSC-derived extra-cellular vesicles call exosomes. 

The purpose of this page is to share information on a novel approach to treating ARDS in high-risk patients using mesenchymal stem cells (MSCs) or MSC-derived exosomes

To learn more about other potential benefits of exosomes, please refer to our exosome overview page.

ARDS Diagnosis
Source: R.E. Ariano, PSAP

How Acute Respiratory Distress Syndrome Kills You - How ARDS Kills You

Video Curated from MedCram YouTube Channel.

ITALY COVID-19 Report March 13, 2020 provided to JAMA

Based on the most recent data as of March 13, 2020 from Italy, we place our focus on the statistics related to those most at risk and how one therapeutic option should be investigated. 

According to the Italian data on deaths from the virus, it was reported to JAMA that those who were confirmed to have the virus fell into the following risk related age categories.

When this data was presented, there were approximately 13,882 recorded cases. These data and percentages may change over time. They may also be different in other countries. 

  • Ages 0-9, deaths in percent: 0%
  • Ages 10-19, deaths in percent: 0%
  • Ages 20-29, deaths in percent: 0%
  • Ages 30-39, deaths in percent: 0.1%
  • Ages 40-49, deaths in percent: 0.1%
  • Ages 50-59, deaths in percent: 1.7%
  • Ages 60-69, deaths in percent: 8.1%
  • Ages 70-79, deaths in percent: 34.2%
  • Ages 80-89, deaths in percent: 44.3%
  • Ages > 90 years, deaths in percent: 9.3%

Again, these numbers are preliminary data shared on the JAMA podcast from an Italian doctor on the front lines of this global issue.

Review the JAMA podcast with Dr. Maurizio Cecconi, below. Dr. Cecconi is an Italian doctor on the front lines. 

JAMA Interview with Dr. Maurizio Cecconi, MD, Humanitas Research Hospital, Italy

Streamed JAMA Interview: March 13, 2020 – Curated from JAMA Podcast.

Below is the Risk of Death Reported by Age Groups

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COVID-19 | Corona Virus: Epidemiology, Pathophysiology, Diagnostics

Video Curated from Ninja Nerd Science YouTube Channel.

How to Attack Acute Respiratory Distress with Mesenchymal Stem Cells and Exosomes

Video content curated from iBiology.

The video demonstrates that once a patient develops ARDS, the mortality rate ranges between 20-30%. If we revisit the Italian data for COVID-19 mortality in adults age 70-89, it closely matches the 34% mortality rate.

It is expected that mortality rates may increase under a stressed system, which is likely why the Italian COVID-19 mortality rate is a bit higher than standard ARDS mortality rates. 

It is believed mesenchymal stem cells and exosomes can improve ARDS in the following ways:

  • Paracrine mechanisms
  • Anti-inflammatory regulation
  • Anti-microbial benefits
  • Various other pathways 

Research on MSC-derived Exosomes for Acute Respiratory Distress Syndrome - ARDS

Delivering Mesenchymal Stem Cells and Exosomes with IV Therapy for Acute Respiratory Distress Syndrome

Video content curated from iBiology.

Mechanisms MSC and MSC-derived exosomes might be effective for enhancing tissue repair when treating ARDS are:

  • Anti-inflammatory properties
  • Restoring endothelial and epithelial integrity
  • By enhancing the clearance of edema fluid from the lungs.
  • Anti-microbial properties
  • Decrease of death in the endogenous cells of the lung.
  • Reduce pro-inflammatory cytokines, time: 17:07.
  • MSCs and MSC derived exosomes will migrate to the lungs if given intravenously. 
  • Paracrine pathways that appear to benefit from MSCs and Exosomes, time: 21:17.
  • Mitochondria & Connexin 43 pathway connection, delivering mitochondria to the injured epithelium. Mitochondria transfer to the injured epithelium allows the injured tissue to work more normally, time 22:17.
  • Safety of MSC (stem cells) and exosomes, time 23:15.
  • In animal models, control group showed a continued decline in oxygenation (hypoxia) while the treated group shows improvement, time 26:15. 
  • Reduction of pulmonary edema in the lung, time 27:00. 
  • Human trials of Stem Cells for ARDS and FDA IND submission, time: 30:50.

Note that stem cells and exosomes have been given to humans intravenously around the world for many years. They have been used for COPD (Stem Cell Therapy for Chronic Obstructive Pulmonary Disease – NIH).

The power of this video shows the restoration of ATP function. This is particularly important to the chronically ill patient whose ATP function has diminished with age, inflammation, and chronic disease impairments, such as hyperinsulinemia or syndrome x.

The paracrine effect from Mesenchymal Stem Cells and Exosomes can modulate inflammatory distress resulting in a potential regenerative activity. In addition, cell to cell communication may be improved in a manner that helps those with age-related chronic diseases to recover better, potentially avoiding ventilation, assuming the disease state is treated with I.V. therapy of MSCs or Exosomes preemptively. 

Stem cells and Exosomes can stimulate and enhance multiple regenerative pathways enabling patients to heal better and faster than normal.  

Note that stem cells and exosomes should not be considered as a standalone therapy for ARDS. An integrative approach consisting of antibiotics like Zithromax among other protocols when needed should also be considered as an integrated approach to ARDS.  [REF: Efficacy of azithromycin in sepsis-associated acute respiratory distress syndrome]. 

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Conventional Standard of Care, Prognosis, and Precautions for COVID-19 and ARDS

Video Curated from Ninja Nerd Science YouTube Channel.

Takeaways

Trump Signs Right to Try Act, 2018 - Is it Time to Demand MSC's or Exosomes for ARDS?

Right to Try Act Signed by President Trump

Trump signs the Right to Try act in 2018. Is it time for you to demand it for conditions like ARDS?

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FAQ for Exosomes and ARDS V 1.01

Relative risk is impossible to assess at this early stage. However, it is likely much lower than other diseases we live with.

Compared to other diseases that cause death, you are more likely to die from heart disease, cancers, diabetes, stroke, and medical error. 

According to John's Hopkins using USA statistics provided by the CDC, here are the leading causes of death in the United States.

Annual Deaths, National Center for Health Statistics as of the Year 2016:

Heart disease: ~ 614,348 deaths (2016)

Cancer: ~ 591,699 deaths (2016)

Medical error: 251,454 (2016)

Respiratory disease: ~ 147,101

Accidents: ~ 136,053

Stroke: ~ 133,103

Alzheimers: ~ 93,541

Diabetes: ~ 76,488

Flu/Pneumonia: ~ 55,227

Kidney Disease: ~ 48,146

Suicide: 42,773

The concern we have with COVID-19 is a rush of patients whereby hospitals won't have the surge capacity to treat all those who need care. 

No. There are clinical trials in place for Stem Cell therapies currently. Stem cell therapy and exosomes therapies for ARDS are recommended via I.V. Exosomes are the extracellular vesicles of stem cell therapies responsible for the beneficial regenerative cascade for recovery. 

Many major research universities like Stanford and others have done safety trials using stem cells in humans. Most experts who study stem cell and exosome therapies view stem cells as safe when delivered by the I.V. route. Stem cells and exosomes must be processed using labs following GMP regulations and donated sources are screened according to FDA guidelines.  

A typical hospital stay for acute respiratory distress syndrome cost most patients around $35,000. In many cases, high insurance deductibles may require patients to pay a large portion of this treatment. Typical exosomes I.V. therapies are estimated at around $6,000-$9,000. 

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