convalescent plasma

Month of CIRM: Battling COVID-19

/ Kevin McCormack / Leave a comment

All this month we are using our blog and social media to highlight a new chapter in CIRM’s life, thanks to the people of California approving Proposition 14. We are looking back at what we have done since we were created in 2004, and also looking forward to the future.

Dr. John Zaia, City of Hope stem cell researcher

The news that effective vaccines have been developed to help fight COVID-19 was a truly bright spot at the end of a very dark year. But it will be months, in some countries years, before we have enough vaccines to protect everyone. That’s why it’s so important to keep pushing for more effective ways to help people who get infected with the virus.

One of those ways is in a clinical study that CIRM is funding with City of Hope’s Dr. John Zaia. Dr. Zaia and his team, in partnership with the Translational Genomics Research Institute (TGen) in Flagstaff, Arizona, are using something called convalescent plasma to try and help people who have contracted the virus. Here’s the website they have created for the study.

Plasma is a part of our blood that carries proteins, called antibodies, that help defend our bodies against viral infections. When a patient recovers from COVID-19, their blood plasma contains antibodies against the virus. The hope is that those antibodies can now be used as a potential treatment for COVID-19 to help people who are newly infected. 

To carry out the study they are using clinical trial sites around California, including some of the CIRM Alpha Stem Cell Network clinics.

For the study to succeed they’ll first need people who have recovered from the virus to donate blood. That’s particularly appropriate in January because this is National Volunteer Blood Donor Month.

The team has three elements to their approach:

  • A rapid-response screening program to screen potential COVID-19 convalescent plasma donors, particularly in underserved communities.
  • A laboratory center that can analyze the anti-SARS-CoV-2 antibodies properties in COVID-19 convalescent plasma.
  • An analysis of the clinical course of the disease in COVID-19 patients to identify whether antibody properties correlate with clinical benefit of COVID-19 convalescent plasma.

There’s reason to believe this approach might work. A study published this week in the New England Journal of Medicine, found that blood plasma from people who have recovered from COVID-19 can help older adults and prevent them from getting seriously ill with the virus if they get the plasma within a few days of becoming infected.

We are used to thinking of blood donations as being used to help people after surgery or who have been in an accident. In this study the donations serve another purpose, but one that is no less important. The World Health Organization describes blood as “the most precious gift that anyone can give to another person — the gift of life. A decision to donate your blood can save a life, or even several if your blood is separated into its components — red cells, platelets and plasma.”

That plasma could help in developing more effective treatments against the virus. Because until we have enough vaccines for everyone, we are still going to need as much help as we can get in fighting COVID-19. The recent surge in cases throughout the US and Europe are a reminder that this virus is far from under control. We have already lost far too many people. So, if you have recently recovered from the virus, or know someone who has, consider donating blood to this study. It could prove to be a lifesaver.

For more information about the study and how you can be part of it, click here.

Want to help us solve a mystery?

/ Kevin McCormack / 1 Comment
Patient that has recovered from Covid-19 donating blood plasma. Photo courtesy Science Photo

Convalescent plasma has been in the news a lot lately as a potential treatment for people infected with the coronavirus. In August the US Food and Drug Administration (FDA) granted emergency use authorization (EUA) to use these products based on preliminary data that suggested it might help people battling COVID. But there are still a lot of unanswered questions about this approach.

And that’s where you come in.

Plasma is a component of blood that carries proteins called antibodies that are usually involved in defending our bodies against viral infections.  We also know that blood plasma from patients that have recovered from COVID-19, referred to as convalescent plasma, contain antibodies against the virus that can be used as a potential treatment for COVID-19. 

That’s the theory, but the reality is that there are still a lot we don’t know, basic questions such as does it really work, how does it work, does it work for everyone or just some patients? A clinical  grant includes testing the plasma in COVID-19 Positive patients that CIRM is funding with City of Hope, UC Irvine and Translational Genomics Research Institute (TGen) hopes to answer those questions. 

The first step is getting the plasma from people who have recovered from COVID and then testing it to make sure it’s safe and to identify what blood type it is, so you can match that blood type with the person receiving it.

But plasma doesn’t contain just one kind of antibody, there are many antibodies and each one works in a slightly different way. For example, two antibodies, IGM and IGG, target in on the spike protein on the coronavirus. The goal is to block that spike and prevent the virus from spreading throughout the body. IGM has up to 10 ‘arms’ and so has the potential to bind multiple copies of the spike, whereas IGG has only 2 arms, but lasts longer. Both IGM and IGG also come in many different flavors, allowing them to bind to many different parts of the spike, some being more protective than others.

That’s one of the things that this trial is trying to find out. And you can help them do that. The trial needs volunteers, volunteers to donate the plasma and volunteers to try the therapy.

The team is evaluating changes that occur before and after plasma treatment.  Many recipients have no immediate response, a few get dramatically better, and some continue to have symptoms long after discharge from the hospital.  These so-called “long-haulers” can have debilitating problems, months after becoming infected. The study hopes to evaluate these variable responses to plasma treatment.

But more people are needed if we are to truly understand what works best. We need people who are newly infected, those being treated with plasma, and those that have recovered from the virus.

We are particularly interested in recruiting people from the Black and Latinx communities, groups that are often underserved when it comes to access to medical care.

The team has created a website to make it easy to find out more about the clinical trial, and to see if you are a good candidate to be part of it, either as a donor or recipient.

Lives are at stake and time is short so join us, help us find answers to the most pressing medical issue of our times. It’s a chance to do something that might benefit your family, your friends and your community.

Four teaspoons could save a life

/ Kevin McCormack / 2 Comments

Sometimes it’s the smallest things that make the biggest difference. In the case of a clinical trial that CIRM is funding, all it takes to be part of it is four teaspoons of blood.

The clinical trial is being run by Dr. John Zaia and his team at the City of Hope in Duarte, near Los Angeles, in partnership with tgen and the CIRM Alpha Stem Cell Clinic Network. They are going to use blood plasma from people who have recovered from COVID-19 to treat people newly infected with the virus. The hope is that antibodies in the plasma, which can help fight infections, will reduce the severity or length of infection in others.

Dr. John Zaia. Photo courtesy City of Hope

People who have had the virus and are interested in taking part are asked to give four teaspoons of blood, to see if they have enough antibodies. If they do they can then either donate plasma – to help newly infected people – or blood to help with research into COVID-19.

As a sign of how quickly Dr. Zaia and his team are working, while we only approved the award in late April, they already have their website up and running, promoting the trial and trying to recruit both recovered COVID-19 survivors and current patients.

The site does a great job of explaining what they are trying to do and why people should take part. Here’s one section from the site.

Why should I participate in your study?

By participating in our study, you will learn whether you have developed antibodies against SARS-CoV-2, the virus responsible for COVID-19. To do so, you just need to donate a small sample of blood (approximately 4 teaspoons).

If testing show you have enough antibodies, you will have the option of donating plasma that will be used to treat severely ill COVID-19 patients and may help save lives.

If you don’t want to donate plasma, you can still donate blood (approximately 3.5 tablespoons), which will be studied and help researchers learn more about COVID-19.

By donating blood or plasma, you will help us gain information that may be of significant value for patient management in future epidemic seasons.

You don’t even have to live close to one of the clinical trial sites because the team can send you a blood collection kit and information about a blood lab near you so you can donate there. They may even send a nurse to collect your blood.

The team is also trying to ensure they reach communities that are often overlooked in clinical trials. That’s why the website is also in Spanish and Vietnamese.

Finally, the site is also being used to help recruit treating physicians who can collect the blood samples and help infuse newly infected patients.

We often read about clinical trials in newspapers and online. Now you get a chance to not only see one working in real time, you can get to be part of it.

CIRM Board Funds its First Clinical Study for COVID-19

/ Yimy Villa / 1 Comment
Dr. John Zaia, City of hope

Today the governing Board of the California Institute for Regenerative Medicine (CIRM) continued its commitment to help with the coronavirus pandemic by awarding $749,999 to Dr. John Zaia at City of Hope.  He will be conducting a clinical study to administer blood plasma from recovered COVID-19 patients to treat those with the virus.  This marks CIRM’s first clinical study for COVID-19 after approving emergency funding a month earlier.

Plasma is a component of blood that carries proteins called antibodies that are usually involved in defending our bodies against viral infections.  Blood plasma from patients that have recovered from COVID-19, referred to as convalescent plasma, contain antibodies against the virus that can be used as a potential treatment for COVID-19.  Currently, there are challenges with this approach that include: properly identifying convalescent plasma donors i.e. recovered patients, determining eligibility of those with convalescent plasma that want to donate, collection of the plasma, treating patients, and determining if the plasma was effective.

Dr. Zaia and his team at City of Hope will create the COVID-19 Coordination Program, which addresses solutions for all of the challenges listed above. The program will partner with the medical teams at CIRM’s Alpha Stem Cell Clinic Network, as well as infectious disease, pulmonary and critical care teams from medical centers and community hospitals across the state.  Potential donors will be identified and thoroughly screened for eligibility per the established National and State blood banking safety requirements. Finally, the convalescent plasma will be collected from eligible donors and administered by licensed physicians to COVID-19 patients, who will be evaluated for response to the treatment and potential recovery.

“We are in the midst of very challenging times where there is not yet an approved treatment for COVID-19. In response to this, CIRM launched and executed an emergency COVID-19 funding program, which was made possible by our Board, patient advocates, California scientists, external scientific expert reviewers, and our dedicated team,” said Maria T. Millan, MD, President and CEO of CIRM. “With CIRM funding, the City of Hope COVID-19 Coordination program will tap into CIRM’s network of researchers, physicians, and our Alpha Clinics to deliver this treatment to patients in need.  It will also serve the critical role of gathering important scientific data about the plasma, safety, and clinical data from treated patients.”

The Board also approved a discovery stage research project that utilizes stem cell models for a novel approach to vaccine development against the virus causing COVID-19 and another project that uses a unique lung stem cell organoid to identify an effective drug against the virus.

The two awards are summarized in the table below:

CIRM Board Expands COVID-19 Efforts

/ Yimy Villa / Leave a comment
Coronavirus particles, illustration. Courtesy KTSDesign/Science Photo Library

This past Friday, the governing Board of the California Institute for Regenerative Medicine (CIRM) expanded the eligibility criteria for COVID-19 related projects to develop new treatments against the virus.  Just two weeks ago, the Board approved $5 million in emergency funding for COVID-19 research.

One major addition is allowing research related to convalescent plasma to be eligible for CIRM COVID-19 emergency funding.  Plasma is a component of blood that carries cells and antibodies.  Blood plasma from patients that have recovered from COVID-19, referred to as convalescent plasma, contains antibodies against the virus and could be used as a potential treatment for COVID-19 patients.

In addition to this, potential clinical studies of convalescent plasma are now approved for use by the U.S. Food and Drug Administration (FDA) single-patient emergency Investigational New Drug (eIND) pathway as opposed to only a traditional IND.  Before treatments can be tested in humans, a traditional IND needs to be filed.  In an emergency situation such as the coronavirus pandemic, an eIND can be filed to begin testing the treatment faster.

In order to address the disproportionate impact of COVID-19 on underserved communities, priority will be given to projects that directly address these disparities. 

Lastly, potential clinical programs for COVID-19 are now approved to start incurring allowable project costs, at risk, from the date of the application submission deadline.  This would give researchers the opportunity to start their projects earlier and cover project costs retroactively if they are approved for funding.

“The intent behind this amendment is to be responsive to this COVID-19 crisis by leveraging CIRM’s funding programs, processes, and infrastructure within the scientific ecosystem that it has supported to date,” said Maria T. Millan, M.D., President and CEO of CIRM. “By providing an opportunity for the medical and scientific community to gather important data while using convalescent plasma treatment protocols on an emergency basis, CIRM is joining the global effort to expedite treatments to patients in need in the midst of this global pandemic.”

CIRM has established an open call for proposals and will accept applications on a bi-monthly basis.

Please refer to the following Program Announcement for more details:

·      Special Call for COVID-19 Projects

To Submit an Application:

  1. Go to the Grants Management Portal (https://grants.cirm.ca.gov) and log in with your existing CIRM Username and Password. If you do not have a Username, Click on the “New User” link and follow the instructions to create a CIRM Username and password.
  2. After logging in, click on the Menu tab. Select the tab labeled “Open Programs“. Under the section labeled “RFAs and Programs Open for Applications“, click on the “Start a Grant Application” link for your selected program.
  3. Complete each section of the Application by clicking on the appropriate link and following the posted instructions. Proposal templates can be located and submitted under the “Uploads” section.
  4. To submit your Application, click on the “Done with Application” button. The “Done with Application” button will be enabled when all of the mandatory sections have been completed. Please note that once this has been selected, you will no longer be able to make changes to your Application.
  5. To confirm submission of your Application, select the tab labeled “Your Applications” and check the table under the section labeled “Your Submitted Applications“. You will see your Application number and project title listed once the submission process has been completed.