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COVID Update

June 25, 2020

 

Dear Friends of the ARM Foundation for Cell & Gene Medicine:

Two months ago, we wrote you with the first description of cell & gene medicine contributions to finding treatments and alleviating the worldwide burden of COVID-19.

The COVID-19 pandemic is a global crisis that has fundamentally altered our lives. It brings into dramatic relief the need to understand science, nature and the investment we must make in education.  We must become as informed as we can about responding as a community to meet the challenge.

Because the ARM Foundation’s mission is to serve as a trusted education and information resource on the contributions cell and gene medicine can make to patients and caregivers, as a public charity we are compelled to include public health and the response to the COVID-19 pandemic in our educational offerings.

The ARM Foundation, through its staff and partners, are identifying and highlighting resources to help patients and families exposed to COVID-19 understand the underlying pathology of the virus and the pertinence of cell and gene medicine to the diagnosis and treatment of the novel coronavirus. Ultimately, the global community requires a vaccine that can significantly reduce COVID-19’s threat to public health.

Some of the cell and gene medicine contributions to finding treatments, diagnostic tools, and vaccines for COVID-19 are presented here.

 

Cell and Gene Medicine Technologies Used to Fight the COVID-19 Pandemic

 

mRNA Vaccines  Natural and synthetic mRNA can instruct cells to express an antigen that will solicit an immune response to the COVID-19 virus.

 

DNA Based Vaccine Platforms Using a direct intra-tissue DNA injection, treated tissue can produce and secrete viral-like antigens to prime the innate immune system.

 

Mesenchymal Stromal Cells (MSCs)  Transplantation of cells isolated from bone marrow, adipose tissue, umbilical cords, or secreted vesicles from cells has, in some studies, mitigated the burden and duration of Acute Respiratory Disease Syndrome (ARDS) thus providing the possibility of treating some of the sickest patients who currently require ventilators.  A number of companies in our community are investigating the potential for stem cells to treat COVID-19 and Acute Respiratory Distress Syndrome (ARDS) resulting from the virus.

 

CRISPR-Cas Gene Editing Technologies RNA guides using CRISPR-Cas can be developed to recognize two signatures of COVID-19 viral RNA.  Potentially, therapeutic products may result from this work.  At present, FDA has granted one emergency use authorization using CRISPR to detect the novel coronavirus causing COVID-19.

 

Single Cycle Adenovirus Vector Vaccines Several major medical centers in the U.S. and Europe are working on adenovirus vaccines that cannot replicate and therefore cannot cause further infection in the treated individual. The adenovirus vector vaccine expresses an antigen similar to those on the surface of the coronavirus that may enable the immune system to recognize and eliminate the virus in the patient.

 

NK, T, and Modified Immune Cells  Clinical trials to test NK and other immune cells to treat the COVID-19-caused pneumonia are underway.  These cells may be able to attack and neutralize the infected cells and mitigate inflammation.

 

We will add to these lists posted on www.thearmfoundation.org as we become aware of additional information or programs.

 

Another important resource is the COVID-19 Healthcare Coalition, a private-sector led response with more than 500 companies and organizations collaborating in working groups.

 

Questions About Impact on Clinical Trials:

The Foundation is fielding inquiries about the impact of the COVID-19 on clinical trials involving cell and gene medicine, especially in the rare disease and oncology communities. All trials are affected varying by size, scope, impact on supplies, manufacturing schedules, and facilities.  In many cases, patients & trial participants who are immune-compromised face additional risks.

Here are links to the most up-to-date information on the impact of the COVID-19 pandemic on cell and gene therapy clinical programs.

  1. Global Genes
  2. American Society for Transplantation and Cellular Therapy
  3. FDA Guidance
  4. European Medicines Agency

 

Concerns & Questions About Treatment Claims for Unproven Therapies

We are aware of recent claims that stem cells can be used to treat individuals infected with COVID-19.  Stem cells currently are used to resupply the blood system after cancer therapy.  There have been important trials for stem cells to treat some skin and eye diseases, and some immune system disorders. Nevertheless, there currently are no approved stem cell therapies for the prevention or treatment of COVID-19.

The ARM Foundation is coordinating efforts with ARM, ISCT, and ISSCR to provide current information regarding the use of unproven therapies, in particular those offered by unscrupulous “stem cell clinics” or organizations operating outside of established regulatory guidelines.  The FDA has issued over 50 warning letters to companies making unproven claims about COVID-19 treatments.

Please follow these links to learn more about these efforts.

  1. American Society for Gene & Cell Therapy
  2. Cell and Gene Insight Blog – ISCT
  3. The Niche: Knoepfler Lab Stem Cell Blog
  4. International Society for Stem Cell Research
  5. FDA Information Regarding Unapproved Stem Cell Treatments

 

Other Informational Resources

Additional information about how by our partners in the cell and gene therapy community are responding to the COVID-19 pandemic can be found here.

  1. Alliance for Regenerative Medicine
  2. Canadian Centre for Regenerative Medicine
  3. California Institute for Regenerative Medicine

The ARM Foundation for Cell & Gene Medicine,  in partnership with Alliance for Regenerative Medicine (ARM) and International Society for Cell & Gene Therapy (ISCT) will host a webinar on July 7, 2020 on the current status of efforts to develop therapies to treat complications associated with COVID-19 using MSCs. If you would like to participate in the webinar, please look for details at thearmfoundation.org.

The ARM Foundation is committed to helping patients, caregivers, and the general public get the most timely and relevant information on the role of cell and gene medicine in responding to the COVID-19 epidemic. If you have specific questions for the Foundation and our partners, please email info@thearmfoundation.org with the subject line “CGTx COVID-19 Inquiry.”  We respond to every query.

Our collective courage, faith, resourcefulness and commitment to accelerating the development of medicines to help provide enduring solutions to public health threats such as COVID-19 guides us through this crisis. We remain committed to making sure that patients, caregivers, and the general public have access to the most trusted, reliable, information available.

 

Warmest regards,

Morrie Ruffin, Executive Director

Stewart Parker, Chair

THE ARM FOUNDATION FOR CELL & GENE MEDICINE

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