Expanding CIRM’s Alpha Clinics Network to deliver transformative regenerative medicine treatments 

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Almost every day, we hear new reports from the thousands of regenerative medicine clinical trials globally sponsored by hundreds of companies and academic researchers. The California Institute for Regenerative Medicine (CIRM) is a leader in this space supporting some of the most advanced cell and gene therapy clinic trials for a variety of unmet medical needs. With all this current activity, it’s easy to forget that there were only a handful of clinical trials going on just seven years ago. 

A New System for Delivering Treatments 

In 2015, CIRM’s leadership recognized that we were on the cusp of introducing an array of new regenerative medicine clinical trials. However, there was one big concern—the existing clinical delivery systems had limited experience and capacity for managing these new and comparatively complex clinical trials. Cell and gene therapy regenerative medicine treatments require new systems for manufacturing, processing, and delivering treatments to patients.  

In anticipation of the need for clinical bandwidth to support clinical trials, CIRM funded a network of California medical centers to develop teams dedicated to supporting regenerative medicine clinical trials. This network was called the Alpha Clinics Network

Since 2015, the Alpha Clinics Network has grown to include six academic medical centers in California. The Network has treated over a thousand patients in more than 100 clinical trials. CIRM frequently encounters companies and academic researchers that are specifically interested in bringing their research to California to be performed in the Alpha Clinics Network. These research sponsors cite expertise in manufacturing, process, delivery and regulatory compliance as the Networks value proposition. One sponsor summed it up by indicating there are “fewer protocol deviations (errors)” in the Alpha Clinics. 

Expanding the Alpha Clinics Network 

As we enter 2022 with CIRM’s new five year strategic plan, a major aim is to create a broad network of medical centers capable of supporting diverse patient participation in clinical trials.  

As a first step in this effort, CIRM recently announced $80 million in funding to expand the Alpha Clinics Network. This funding is intended to expand both the scale and scope of the Network. This funding will allow the scale to grow from six medical center to up to ten. Scale is important because as the number of clinical trials grow, there needs to be increased coordination and sharing of the workload. Alpha Clinic sites already collaborate to conduct individual clinical trials, and an expanded network will enable a greater number of trials to occur simultaneously. 

In addition, the Expansion Awards will enable the Network to expand the scope of its activities to address current needs of the field. These needs include new research platforms for conducting clinical trials. For example, sites are looking at integrating new types of genomic (DNA sequencing) tools to support improved diagnosis and treatment of patients.  

Also, CIRM is committed to funding research to treat neurological diseases. We anticipate network sites will develop advanced systems for delivering treatments to patients and evaluating the effectiveness of these treatments. In addition, sites will be developing training programs to address the growing workforce needs of the field of regenerative medicine. 

In 2015, CIRM invested in the Alpha Clinics Network which positioned California as a leader in supporting regenerative medicine clinical trials. In 2022, we will be expanding the Network with the aim of delivering transformative treatments to a diverse California and the world. The Network will fulfill this aim by expanding its reach in the state, developing advanced research planforms and technologies, and by training the next generations of researchers with the skills to deliver patient treatments. 

Watch a recording of our recent Alpha Clinics concept plan webinar: 

CIRM CNS Consortium Workshop – Held Feb. 24 & 25, 2022

Note: Post edited to include post-event workshop videos. Watch both workshop videos here and here.

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Shared Stem Cell Laboratory at UCLA

Advance World Class Science, Deliver Real World Solutions, Provide Opportunity for All. 

These comprise the themes of our bold 5-year Strategic Plan. Since its launch less than two months ago, we have hit the ground running. Under the second and third strategic themes, we have already received ICOC approval for 2 concepts: Alpha Clinics Network Expansion and COMPASS educational program. We are now working on the execution of our first theme.  

As indicated in our Strategic Plan, we strongly believe advancing world class science relies on collaborative research that leverages collective scientific knowledge. To that end, we have organized the virtual CIRM CNS Consortium Workshop (click for the agenda and see registration details below) to help us gather feedback from a panel of experts about the best approach for promoting a culture of collaboration.

The vision for this workshop was informed by multiple layers of stakeholder discussions and input that started even prior to the passage of Proposition 14. A quick walk down memory lane reminds us of CIRM’s early and deliberate effort to identify areas of opportunity for promoting a paradigm shift with a “team science” approach, especially in the context of complex diseases such as those affecting the CNS: 

  • In 2019, we organized Brainstorming Neurodegeneration, a workshop where broad stakeholder input was received about the benefits and bottlenecks of developing a consortium approach where genomics and big data, novel stem cell models, and patient data could be collectively leveraged to advance the field of neurodegenerative research in a collaborative manner.  
  • In 2020, just before the passage of Prop 14 and based on input from the 2019 workshop, we already had our eyes on target: the future of collaborative research is in sharable data, and sharing petabytes or more of data requires a collaborative data infrastructure. To better understand the status and bottlenecks of knowledge platforms that could leverage data sharing, we brought together a panel of experts at our 2020 Grantee Meeting. We were encouraged to learn that our laser-focused approach for promoting knowledge sharing was right on target and the panelists suggested that CIRM has a great opportunity to promote a paradigm shift in this area.   
  • In early 2021, immediately after the passage of Prop 14 and building upon our previous conversations, we formed a Strategic Scientific Advisory Panel comprising a distinguished group of national and international scientists in the stem cell field. Once again, we were advised to expand sharable resources (especially in the context of stem cell modeling), bring more attention to complex diseases such as neurodegenerative and neuropsychiatric disorders, and facilitate knowledge sharing.  
  • In mid 2021, as we were forming our Strategic Plan based on the above input, we pressure-tested our paradigm-shifting vision in a Town Hall and further gathered feedback from California stakeholders about their needs. Again, all arrows pointed to shared resources and data as critical elements for accelerating research.  
CIRM Town Hall workshop hosted in 2021
  • Finally, in late 2021, just before the launch of our Strategic Plan, we organized a Data Biosphere Advisory Committee to advise us on ways to facilitate collaborative knowledge sharing. Here, we explored various models for leveraging and/or generating a data infrastructure in which CIRM-funded data could be managed and shared. The main outcome of this meeting was a recommendation to organize a workshop to test the feasibility and approach for generation of a CIRM knowledge platform. The Committee concluded that CIRM is uniquely positioned to contribute a wealth of data to the broader scientific community. A knowledge platform would provide an avenue for data sharing and collaboration with other groups that are dedicated to accelerating progress in the development of therapies, especially for CNS disorders.  

We were walking on solid ground! In December of 2021, paralleling the input we had received from experts and stakeholders, we launched our 5-year Strategic Plan with the goal of advancing world class science by promoting a culture of collaboration. 

To deliver on this goal, CIRM’s approach is to build the infrastructure (and we don’t mean bricks and mortar) that organizes and democratizes data through:  

  1. A network of shared resources labs that facilitate validation and standardization to support California regenerative medicine researchers  
  1. A data infrastructure where CIRM-funded data can be shared and external datasets leveraged to maximize real-world impact  
  1. We have held a virtual CNS Consortium Workshop on February 24th and 25th where we explored the development of these two resources through the deployment of a consortium and starting in the CNS space as a use case. While the discussions at the workshop centered on the CNS, the shared resources labs will be implemented across cell types and organs. The Data Infrastructure is intended to be a global resource for data sharing and fostering a culture of open science for all CIRM grantees—and the world. The complete workshop agenda can be found here.  

    Watch video recordings of Day 1 and Day 2 of the CNS workshop.

Making stem cell and gene therapies available and affordable for all California patients

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Developing a new therapy: Photo courtesy UCLA

There is no benefit in helping create a miraculous new therapy that can cure people and save lives if no one except the super-rich can afford it. That’s why the California Institute for Regenerative Medicine (CIRM) has made creating a roadmap to help make new treatments both available and affordable for all Californians a central pillar of its new 5-year Strategic Plan.

New treatments based on novel new technologies often seem to come with a gob-smacking price tag. When Kymriah, a CAR-T cell cancer therapy, was approved it cost $475,000 for one treatment course. When the FDA approved Zolgensma to treat spinal muscular atrophy, a genetic disorder that causes muscle wasting and weakness, the cost was $2.1 million for one dose.

Part of the pricing is due to high manufacturing cost and the specialized resources needed to deliver the treatments. The treatments themselves are showing that they can be one-and-done options for patients, meaning just one treatment may be all they need to be cured. But even with all that innovation and promise the high price may impact access to patients in need.

At CIRM we believe that if California taxpayer money has helped researchers develop a new therapy, Californians should be able to get that therapy. To try and ensure they can we have created the Accessibility and Affordability Working Group (AAWG). The groups mission is to find a way to overcome the hurdles that stand between a patient and the treatment they need.

The AAWG will work with politicians and policy makers, researchers and regulators, insurance companies and patient advocate organizations to gather the data and information needed to make these therapies available and affordable. Dr. Le Ondra Clark Harvey, a CIRM Board member and mental health advocate, says the barriers we have to confront are not just financial, they are racial and ethnic too. 

We have already created a unique model for delivering stem cell therapies to patients through our Alpha Stem Cell Clinic Network. We are now setting out to build on that with our commitment to creating Community Care Centers of Excellence. But having world-class clinics capable of delivering life-saving therapies is not enough. We also need to make sure that Californians who need these treatments can get them regardless of who they are or their ability to pay.

To learn more read out new Strategic Plan.

How these scholars are growing the regenerative medicine field in California

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CIRM Scholar Alessandra Rodriguez y Baena

Through our new Strategic Plan, the California Institute for Regenerative Medicine (CIRM) will build inclusive participation opportunities for all stakeholders, from the students to the workforce to the patients.  

That said, it’s important to recognize the important work CIRM has already done to train the next generation of scientists and grow the field of regenerative medicine. Alessandra’s story illustrates just one of the many ways we have done that in the past, and we intend to do even more in the future. 

Gaining Exposure to Innovative Research

CIRM Scholar Alessandra Rodriguez y Baena was a Master’s student at Cal Poly, San Luis Obispo. With the support of CIRM’s Bridges Program, she became a CIRM intern in the Willert Lab at UC San Diego.  

As a student researcher, CIRM provided her with supportive mentors (both at Cal Poly and UCSD), hands-on training in the field of regenerative medicine, and exposure to innovative ideas and research. The program also provided Alessandra with a stipend to help cover expenses. This was particularly helpful for students from low-income backgrounds who otherwise might not be able to afford to go to college. 

“I always recommend my undergraduate students who are interested in research to apply to the Bridges programs because, to me, it was a defining experience that led me to pursue my passion for stem cell research as well as teaching,” Alessandra says. 

Alessandra is now a fourth-year PhD student in the Forsberg Lab in the department of Molecular, Cell & Developmental Biology at UC Santa Cruz where she is studying the epigenetic regulation of aging in bone marrow stem cells.  

In addition to Alessandra, CIRM has provided opportunities in science to nearly 3,000 students across California. These include high schoolers in our SPARK Program, as well as undergrads and graduate students in our Bridges Program and pre and post-doctoral students in our Research Training program. Many of these are from diverse backgrounds.  

A Game Changer

Sneha Santosh, another CIRM Scholar, first heard about CIRM’s Bridges to Stem Cell Therapy and Research internship when she was graduating from the UC Davis. She was pursuing a degree in microbial biotechnology and thinking about getting a master’s degree in biotechnology. She said the opportunity to be part of a program that is training the next generation of scientists was a game changer for her.  

Through the Bridges Program, she learned about stem cells’ power to treat a disease’s root cause rather than just the symptoms. She saw how these transformative therapies changed people’s lives. 

Today, she is a cell culture associate with Novo Nordisk, a leading global healthcare company in Fremont, California 

CIRM’s New Strategic Plan

Alessandra and Sneha’s stories capture CIRM’s commitment to building education and training programs, and providing opportunities to build a diverse, highly skilled regenerative medicine workforce. We’ll be covering this ambitious yet achievable goal in our upcoming blog posts.  

To learn more about CIRM’s work and plans build the regenerative medicine field, check out our new 5-year strategic plan on our website.  

Overcoming obstacles and advancing treatments to patients

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UC Davis GMP Manufacturing facility: Photo courtesy UC Davis

When you are trying to do something that has never been done before, there are bound to be challenges to meet and obstacles to overcome. At the California Institute for Regenerative Medicine (CIRM) we are used to coming up with great ideas and hearing people ask “Well, how are you going to do that?”

Our new 5-year Strategic Plan is how. It’s the roadmap that will help guide us as we work to overcome critical bottlenecks in bringing regenerative medicine therapies to people in need.

Providing more than money

People often think of CIRM as a funding agency, providing the money needed to do research. That’s true, but it’s only part of the story. With every project we fund, we also offer a lot of support. That’s particularly true at the clinical stage, where therapies are being tested in people. Projects we fund in clinical trials don’t just get money, they also have access to:

  • Alpha Stem Cells Clinic Network – This is a group of specialized medical centers that have the experience and expertise to deliver new stem cell and gene therapies.
  • The CIRM Cell and Gene Therapy Center – This helps with developing projects, overcoming manufacturing problems, and offers guidance on working with the US Food and Drug Administration (FDA) to get permission to run clinical trials.
  • CIRM Clinical Advisory Panels (CAPs) – These are teams put together to help advise researchers on a clinical trial and to overcome problems. A crucial element of a CAP is a patient advocate who can help design a trial around the needs of the patients, to help with patient recruitment and retention.

Partnering with key stakeholders

Now, we want to build on this funding model to create new ways to support researchers in bringing their work to patients. This includes earlier engagement with regulators like the FDA to ensure that projects match their requirements. It includes meetings with insurers and other healthcare stakeholders, to make sure that if a treatment is approved, that people can get access to it and afford it.

In the past, some in the regenerative medicine field thought of the FDA as an obstacle to approval of their work. But as David Martin, a CIRM Board member and industry veteran says, the FDA is really a key ally.

“Turning a promising drug candidate into an approved therapy requires overcoming many bottlenecks… CIRM’s most effective and committed partner in accelerating this is the FDA.”

Removing barriers to manufacturing

Another key area highlighted in our Strategic Plan is overcoming manufacturing obstacles. Because these therapies are “living medicines” they are complex and costly to produce. There is often a shortage of skilled technicians to do the jobs that are needed, and the existing facilities may not be able to meet the demand for mass production once the FDA gives permission to start a clinical trial. 

To address all these issues CIRM wants to create a California Manufacturing Network that combines academic innovation and industry expertise to address critical manufacturing bottlenecks. It will also coordinate training programs to help build a diverse and expertly trained manufacturing workforce.

CIRM will work with academic institutions that already have their own manufacturing facilities (such as UC Davis) to help develop improved ways of producing therapies in sufficient quantities for research and clinical trials. The Manufacturing Network will also involve industry partners who can develop facilities capable of the large-scale production of therapies that will be needed when products are approved by the FDA for wider use.

CIRM, in collaboration with this network, will also help develop education and hands-on training programs for cell and gene therapy manufacturing at California community colleges and universities. By providing internships and certification programs we will help create a talented, diverse workforce that is equipped to meet the growing demands of the industry.

You can read more about these goals in our 2022-27 Strategic Plan.

CIRM-funded stem cell clinical trial patients: Where are they now?

Ronnie with his parents Pawash Priyank and Upasana Thakur.

Since its launch in 2004, the California Institute for Regenerative Medicine (CIRM) has been a leader in growing the stem cell and regenerative medicine field while keeping the needs of patients at the core of its mission. 

To date, CIRM has:  

  • Advanced stem cell research and therapy development for more than 75 diseases. 
  • Funded 76 clinical trials with 3,200+ patients enrolled. 
  • Helped cure over 40 children of fatal immunological disorders with gene-modified cell therapies. 

One of these patients is Ronnie, who just days after being born was diagnosed with severe combined immunodeficiency (SCID), a rare immune disorder that is often fatal within two years. 

A recent photo of Ronnie enjoying a day at the beach.

Fortunately, doctors told his parents about a CIRM-funded clinical trial conducted by UC San Francisco and St. Jude Children’s Hospital. Doctors took some of Ronnie’s own blood stem cells and, in the lab, corrected the genetic mutation that caused the condition. They then gave him a mild dose of chemotherapy to clear space in his bone marrow for the corrected cells to be placed and to grow. Over the next few months, the blood stem cells created a new blood supply and repaired Ronnie’s immune system. He is now a happy, healthy four-year-old boy who loves going to school with other children. 

Evie Junior participated in a CIRM-funded clinical trial in 2020. Photo: Jaquell Chandler

Another patient, Evie Junior, is pioneering the search for a cure for sickle cell disease: a painful, life-threatening condition.  

In July of 2020, Evie took part in a CIRM-funded clinical trial where his own blood stem cells were genetically modified to overcome the disease-causing mutation. Those cells were returned to him, and the hope is they’ll create a sickle cell-free blood supply. Evie hasn’t had any crippling bouts of pain or had to go to the hospital since his treatment.

To demonstrate treatment efficacy, study investigators will continue to monitor the recovery of Evie, Ronnie, and others who participate in clinical trials. 

CIRM’s new strategic plan seeks to help real life patients like Ronnie and Evie by optimizing its clinical trial funding partnership model to advance more therapies to FDA for approval.  

In addition, CIRM will develop ways to overcome manufacturing hurdles for the delivery of regenerative medicine therapies and create Community Care Centers of Excellence that support diverse patient participation in the rapidly maturing regenerative medicine landscape. Stay tuned as we cover these goals here on The Stem Cellar. 

To learn more about CIRM’s approach to deliver real world solutions for patients, check out our new 5-year strategic plan.  

Sharing ideas and data to advance regenerative medicine

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If Kindergarten kids can learn to share why can’t scientists?

When I was a kid, we were always told to share our toys. It was a good way of teaching children the importance of playing nice with the other kids and avoiding conflicts.

Those same virtues apply to science. Sharing data, knowledge and ideas doesn’t just create a sense of community. It also helps increase the odds that scientists can build on the knowledge gained by others to advance their own work, and the field as a whole.

That’s why advancing world class science through data sharing is one of the big goals in CIRM’s new Strategic Plan. There’s a very practical reason why this is needed. Although most scientists today fully appreciate and acknowledge the importance of data sharing, many still resist the idea. This is partly for competitive reasons: the researchers want to publish their findings first and take the credit.

But being first isn’t just about ego. It is also crucial in getting promotions, being invited to prestigious meetings, winning awards, and in some cases, getting the attention of biopharma. So, there are built-in incentives to avoiding data sharing.

That’s unfortunate because scientific progress is often dependent on collaboration and building upon the work of other researchers.

CIRM’s goal is to break down those barriers and make it easier to share data. We will do that by building what are called “knowledge networks.” These networks will streamline data sharing from CIRM-funded projects and combine that with research data from other organizations, publishers and California academic institutions. We want to create incentives for scientists to share their data, rather than keep it private.

We are going to start by creating a knowledge network for research targeting the brain and spinal cord. We hope this will have an impact on studying everything from stroke and Alzheimer’s to Parkinson’s and psychiatric disorders. The network will eventually cover all aspects of research—from the most basic science to clinical trials—because knowledge gained in one area can help influence research done in another.

To kick start this network, CIRM will partner with other funding agencies, disease foundations and research institutions to enable scientists to have access to this data such that data from one platform can be used to analyze data from another platform. This will amplify the power of data analysis and allow researchers to build upon the work of others rather than repeat already existing research.

As one of our Board members, Dr. Keith Yamamoto said in our Strategic Plan, “Making such data sharing and analysis across CIRM projects operational and widely accessible would leverage CIRM investments, serving the biomedical research enterprise broadly.”

It’s good for science, but ultimately and more importantly, it’s good for all of us because it will speed up the development of new approaches and new therapies for a wide range of diseases and disorders.

Visit this page to learn more about CIRM’s new 5-year Strategic Plan and stay tuned as we share updates on our 5-year goals here on The Stem Cellar.

Empowering and connecting California’s research ecosystem through shared labs

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A shared stem cell laboratory at UCLA

The California Institute for Regenerative Medicine (CIRM) has set ambitious goals in its new 5-year strategic plan. Made possible by renewed funding through Proposition 14, the plan lays out a roadmap for CIRM as the agency continues to advance world class science, deliver real world solutions, and provide opportunity for all.

In regenerative medicine (and many other fields), the lack of protocol standardization and lack of analytical toolkits make it difficult to access novel and reliable technology platforms.

CIRM recognizes these limitations, and as a response, the Agency has made it a goal in the “Prop 14 era” to develop next-generation competency hubs that empower and connect California’s research ecosystem.

One example of such competency hubs is the shared labs. The concept of shared labs isn’t new to CIRM. In fact, CIRM has awarded a total of 17 shared research laboratory grants to academic and nonprofit research institutions to provide lab space for innovative stem cell research and training.

CIRM will expand this shared lab model by creating networks of specialized competency hubs that offer knowledge and/or materials in cell and gene therapy development. These hubs will encourage collaborations and provide intra- and inter-institutional access to various competencies by sharing facilities, training, equipment, materials, protocols, and/or expertise.

As an example, a disease modeling competency hub would provide access to innovative models used to study diseases, collaborative researchers, shared facilities for conducting research, equipment and training programs for deriving or differentiating cell lines, etc. These collaborative environments would encourage researchers to work together with a team science approach, which would significantly accelerate discovery and therapy development.

Some of these hubs will also serve as a workforce training program for local and neighboring institutions. Most California state universities and community colleges have neither the financial nor experiential bandwidth for innovative research. They may, however, harbor a potentially diverse future workforce who could learn these techniques and use the technology platforms for small scale research. Training may also trigger the interest of the future workforce in pursuing the field of regenerative medicine.  

The competency hubs will also constitute part of the CIRM collaborative ecosystem making all their data available through the CIRM data infrastructure hub, also known as CIRM knowledge networks.

Finally, the network of competency hubs will greatly benefit the people of California by expanding geographic access to diverse communities and providing researchers with a unique opportunity of exposure to state-of-the-art platforms.

Visit this page to learn more about CIRM’s new 5-year Strategic Plan, and stay tuned as we share progress updates on our 5-year goals here on the Stem Cellar.

How two California researchers are advancing world class science to develop real life solutions

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In our recently launched 5-year Strategic Plan, the California Institute for Regenerative Medicine (CIRM) profiled two researchers who have leveraged CIRM funding to translate basic biological discoveries into potential real-world solutions for devastating diseases.

Dr. Joseph Wu is director of the Stanford Cardiovascular Institute and the recipient of several CIRM awards. Eleven of them to be exact! Over the past 10 years, Dr. Wu’s lab has extensively studied the application of induced pluripotent stem cells (iPSCs) for cardiovascular disease modeling, drug discovery, and regenerative medicine. 

Dr. Wu’s extensive studies and findings have even led to a cancer vaccine technology that is now being developed by Khloris Biosciences, a biotechnology company spun out by his lab. 

Through CIRM funding, Dr. Wu has developed a process to produce cardiomyocytes (cardiac muscle cells) derived from human embryonic stem cells for clinical use and in partnership with the agency. Dr. Wu is also the principal investigator in the first-in-US clinical trial for treating ischemic heart disease. His other CIRM-funded work has also led to the development of cardiomyocytes derived from human induced pluripotent stem cells for potential use as a patch.

Over at UCLA, Dr. Lili Yang and her lab team have generated invariant Natural Killer T cells (iNKT), a special kind of immune system cell with unique features that can more effectively attack tumor cells. 

More recently, using stem cells from donor cord-blood and peripheral blood samples, Dr. Yang and her team of researchers were able to produce up to 300,000 doses of hematopoietic stem cell-engineered iNKT (HSC–iNKT) cells. The hope is that this new therapy could dramatically reduce the cost of producing immune cell products in the future. 

Additionally, Dr. Yang and her team have used iNKT cells to develop both autologous (using the patient’s own cells), and off-the-shelf anti-cancer therapeutics (using donor cells), designed to target blood cell cancers.

The success of her work has led to the creation of a start-up company called Appia Bio. In collaboration with Kite Pharma, Appia Bio is planning on developing and commercializing the promising technology. 

CIRM has been an avid supporter of Dr. Yang and Dr. Wu’s research because they pave the way for development of next-generation therapies. Through our new Strategic Plan, CIRM will continue to fund innovative research like theirs to accelerate world class science to deliver transformative regenerative medicine treatments in an equitable manner to a diverse California and the world.

Visit this page to learn more about CIRM’s new 5-year Strategic Plan and stay tuned as we share updates on our 5-year goals here on The Stem Cellar.

Stem Cell Agency Board Approves Roadmap for Next Five Years

Dr. Maria Millan, CIRM’s President & CEO

It’s hard to get somewhere if you don’t know where you are going. Without a map you can’t plan a route to your destination. That’s why the CIRM Board approved a new Strategic Plan laying out a roadmap for the Stem Cell Agency for the next five years.

The plan builds on the achievements of Proposition 71, the voter approved ballot initiative that created the Agency in 2004, including:

  • Supporting 76 clinical trials.
  • Helping cure more than 40 children born with a rare, fatal immune disorder.
  • Creating the Alpha Clinics Network that specializes in the delivery of stem cell therapies to patients.
  • Training over 3000 students and scholars to become the future workforce of regenerative medicine.
  • Stimulating California’s economy with $10.7 Billion in additional sales revenue and the creation of 56,000 new jobs (between 2004-2018)

The passage of Proposition 14 in 2020 has positioned CIRM to continue to accelerate research from discovery to clinical; to drive innovative, real-world solutions resulting in transformative treatments for patients; and to ensure the affordability and accessibility of those treatments to a diverse community of patients in an equitable manner, including those often overlooked or underrepresented in the past.

“We achieved a lot in the last 15 years and this provides a solid foundation for our strategy to bring us to the new era of CIRM and to deliver the full potential of regenerative medicine, says Dr. Maria T. Millan, the President and CEO of CIRM. “This plan lays out a roadmap for us to overcome the challenges in developing transformative therapies and making them accessible and affordable in an equitable fashion to a diverse California. The plan will guide us in that work through the development of novel scientific endeavors, effective healthcare delivery models, and expanded education and training programs.”

The Strategic Plan is organized into three main themes:

  • Advance World Class Science – Foster a culture of collaborative science by creating knowledge networks and shared research tools and technologies that encourage and facilitate data and resource sharing.
  • Deliver Real World Solutions – Accelerate approval of therapies by optimizing our support models for CIRM-funded clinical trials with attention to including underserved communities; build the California Manufacturing Network to overcome manufacturing hurdles; and expand the Alpha Clinics network and create the Community Care Centers of Excellence to deliver therapies to a diverse patient population often in underserved communities.
  • Provide Opportunity for All – Build a racially, ethnically and experientially diverse and highly skilled workforce to support the growing regenerative medicine economy in California; deliver a roadmap for access and affordability of regenerative medicine for all California patients.

Reflecting these goals, CIRM’s new mission statement is: Accelerating world class science to deliver transformative regenerative medicine treatments in an equitable manner to a diverse California and world.

“We realize that these are ambitious goals but they are achievable,” says Dr. Millan, “If CIRM is going to continue to be a global leader in the field of regenerative medicine, and to live up to the faith shown in us by the people of California, we believe we have to aim high. We have a terrific team, a clear vision and a determination to fulfill our mission. And that’s what we intend to do.”