Global Growth in 2020 for Regenerative Medicine While California's Stem Cell Program Faces Extinction

ARM graphic

SAN FRANCISCO -- Leaders of the stem cell and regenerative medicine industry gathered yesterday at a sumptuous hotel here, and the talk was of billions of dollars in business, not to mention medical treatments that can cost millions. 

Just 11 miles away across the famed San Francisco Bay, however, was another sort of stem cell scene. It could be found in the not-so-posh, Oakland headquarters of the state stem cell program, known officially as the California Institute for Regenerative Medicine (CIRM) . 

CIRM is going broke. Its original $3 billion has shrunk to $27 million over the last 15 years. 

On the other hand, global financing for therapies and treatments in the regenerative medicine field totaled nearly $10 billion in 2019, marking the second highest year ever, the leading U.S. industry group reported at the session at the Parc 55 hotel.

Janet Lambert, CEO of ARM -- ARM photo

"2019 (was) a year of significant growth in the regenerative medicine sector," said Janet Lambert, CEO of the Alliance for Regenerative Medicine (ARM), told a standing-room-only crowd of more than 500 gathered for its annual briefing. "We enter 2020 poised for continued expansion."

Lambert said,

"The pipeline is robust, with several next-gen technologies entering the clinic and an increase in clinical trials for indications with large patient populations."

Her comments came as CIRM faces a financing shortfall that could mean its virtual extinction. 

The agency, created in 2004 by state voters, is down to its last $27 million of uncommitted cash. CIRM has often spent close to $300 million a year. The agency is hoping voters next November will provide it with $5.5 billion more under the terms of a ballot initiative yet to qualify for the ballot. CIRM's only significant source of funding is bonds issued by the state. 

Lambert's organization has more than 350 members, including CIRM. The largest percentage of ARM's membership comes from cell and gene therapy companies. The global financing it reports is almost entirely private. 

ARM's 2019 survey tracked nearly 1,000 companies globally, including 534 in the United States. The second largest number, 237, includes Europe and Israel. Lambert said the fastest growing area is Asia, which has 180.

ARM counted 94 phase three clinical trials globally, the last stage before a therapy is approved for widespread use by the federal government. 

CIRM is helping to finance 60 clinical trials, including three that are still active in phase three. It has yet to back research that has led to a widely available product.

Here are links to CIRM's phase three trials: BrainStorm Cell Therapeutics,  $16 million, ALS, PI Ralph Kern; Humacyte, Inc., $10 million, kidney failure, PI Jeffrey Lawson; Medeor Therapeutics, $11 million, kidney failure, PI Karen Smith. 

Here is a link to Lambert's slides. In the near future, ARM expects to mount online a video of her presentation including two additional panel sessions that examine the current and future outlook for regenerative medicine.