The California Stem Cell Research, Treatments, and Cures Initiative of 2020

Most readers of Spinal Connections are probably aware that the California Institute of Regenerative Medicine (CIRM) is in the final stages of funding grants from Proposition 71, passed by a substantial majority of California voters in 2014. At its October 31 meeting, the governing board called the “Independent Citizen’s Oversight Committee” (ICOC) approved $32.92 million to fund CIRM's first clinical trial in Parkinson's Disease and to support three clinical trials targeting different forms of vision loss. This brings the total number of clinical trials funded by CIRM to 60 and expends all funds available for new projects except for the set aside for co-funding of projects on sickle cell disease in cooperation with the NIH.

A coalition led by Bob Klein, recognized as the primary driving force for Prop 71, has been working on a new initiative for the 2020 election, and on November 18, the coalition filed the final version with the State Attorney General as the first step in getting the measure approved for the 2020 ballot.

The new initiative is called “The California Stem Cell Research, Treatments, and Cures Initiative of2020”. The full text of the initiative can be found on the Attorney General’s website. Some key provisions are:

1. To provide $5.5 billion in bond funding to allow CIRM to continue funding stem cell and other vital research to develop treatments and cures for serious diseases and conditions.
2. Dedicating $1.5 billion for research and the development of treatments for diseases and conditions of the brain and central nervous system.
3. Promoting accessibility and affordability of treatments and cures by ensuring that more Californians have the opportunity to participate in clinical trials expanding the number and geographic reach of clinics where specialized treatments and cures can be provided, including centers of excellence like Alpha Stem Cell Clinics and Community Care Centers of Excellence, and by helping California patients obtain treatments and cures that arise from institute-funded research and development.

There are also new provisions to enhance accountability and transparency, including rigorous conflict of interest rules and a cap on administrative expenditures to ensure that at least 92.5% of the bond proceeds are spent on research and the development and delivery of treatments and cures.

Bonds would be issued over a period of at least 10 years with payments postponed for the first five years and with total cost spread over a period of up to 40 years. The logic here is that the repayment is aligned with the period of time over which California patients are expected to benefit from institute funded research.

The next step will be to gather the necessary number of signatures to qualify the initiative on the ballot.

One feature of the new initiative that’s particularly noteworthy is what is eligible for funding: “stem cell and other vital research”. Funds from the original Prop. 71 were almost entirely limited to stem cell research. It was only in 2019 that a project on gene editing was approved as a “vital research opportunity”, which required a 2/3 vote of the Grants Working Group. Eligibility as “vital research” in the 2020 proposition requires only a majority vote. Including other vital research is important because of the major strides being made to use gene modifying therapies to cure some of the most profound diseases and disorders.

This was highlighted in 2018 by accelerated approval of an AAV-based gene modifying therapy for spinal muscular atrophy (SMA), which is showing remarkable success in preventing disease progression and early death of children with SMA. Going forward, there may be other vital research opportunities for treating diseases and disorders that we can’t even imagine today, as was the case for the development of iPS technology during the first round of funding from Prop 71.

Most readers will also know that Os Steward was a founding member of the ICOC and is one of only 3 original members who still serve on the board. As an ICOC member, Dr. Steward is prohibited from expressly advocating for the new ballot measure. If all of the above sounds dry and factual, this is the reason. Going forward, we will continue to provide informational material regarding the accomplishments of CIRM and the new ballot measure.