Coffman works with local physician to push stem-cell therapy bill

The Denver Business Journal

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Washington, DC, June 29, 2016 | By Ed Sealover | comments

As most congressional watchers begin to turn their attention to the November elections, U.S. Rep. Mike Coffman canvassed the northern Front Range on Wednesday — not for campaign purposes, but to make a last-ditch effort to move a health-care bill of his that has been stuck in limbo.

Coffman, an Aurora Republican, is the House sponsor of the REGROW Act, which would speed physicians’ ability to use experimental stem-cell therapies, allowing for clinical trials on patients once safety, rather than safety and efficacy, is demonstrated. He argues that such a streamlining of the U.S. Food and Drug Administration’s approval process not only would give patients access to life-changing therapies but would save hundreds of millions of dollars for Medicare by allowing expensive surgeries to be replaced in many cases by injections of stem cells.

Coffman is facing several obstacles. First, FDA officials oppose the bill, arguing that it will undermine the current testing process that’s in place to ensure drugs and therapies are proper for mass usage before they hit the market. Second, he faces a packed calendar before the congressional session adjourns at the end of this year, and even getting a hearing will be tough, he acknowledged.

But in his effort to advance the bill, Coffman on Wednesday visited the Centeno-Schultz Clinic in Broomfield, a privately funded center for regenerative medicine that researches the effectiveness of stem-cell treatments and trains about 1,000 doctors a year on how to use the therapies to replace expensive surgeries in many cases. After that visit, he was headed to Fort Collins, hoping to meet with researchers at Colorado State University who have been doing stem-cell research for more than 10 years.

“I think it’s important to prioritize it,” Coffman said. “If we can come across something that’s less invasive with better outcomes and cheaper, it could be a game changer.”

Centeno and other physicians from his clinic have been tracking about 11,000 patients they’ve treated over the past 11 years and have found that injecting stem cells to partially torn joints can cut back on the number of orthopedic surgeries by 70 percent.

In instances of ACL tears or rotator cuff injuries, doctors have gone into the joints with ultrasound guidance, found the tears and injected cells into those areas. The recovery time is much quicker, the morbidity rate zero and the costs for such procedures drop from some $25,000 for knee replacements to about $6,000, he said.

FDA rules now give those physicians carte blanche on standard injections that are considered non-invasive procedures. But stem cells that are taken from fat, that are cultured or that are modified genetically are considered drugs — and the FDA has not given approval for those to be used in the U.S., despite lengthy studies, Centeno said.

Because of that, physicians from the Regenexx network — a group of about 35 locations throughout the U.S. and in select overseas locations for which the Centeno-Schultz Clinic is the headquarters — must take patients to their locations in Grand Cayman, the Bahamas or Japan for such procedures. And without FDA approval, those procedures are largely limited to self-paying clients rather than Medicare patients or others who could benefit from them Centeno said.

Centeno asked Coffman Wednesday to ensure in any legislation that passes that the FDA does not reverse course on non-invasive stem-cell therapy procedures and rule that they too must go through the full drug-testing process, which could take a decade or more and require tens of millions of dollars to be spent on trials. Coffman replied that if he can’t work it into the existing bill, he can think about running a stand-alone resolution on that matter.

The question now is whether Coffman can persuade House leaders to use the remaining months of this Congress to advance the bill.

“Technology has historically increased health-care costs,” said the fourth-term congressman, who faces a high-profile challenge from Democratic state Sen. Morgan Carroll in the election this year. “This is an opportunity for an advancement that can reduce costs and improve outcomes.”

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