Should Kansas spend $500K on stem cell COVID research? Bill splits KU Med leaders, advisory board – The Topeka Capital-Journal


State lawmakers want to send half a million dollars to the University of Kansas Medical Center for a COVID-19 stem cell research project that school leadership don’t appear to support.
Despite concerns raised by leadership at KU Med and the school’s Midwest Stem Cell Therapy Center, the center’s advisory board pushed for Senate Bill 373. The bill, which would allocate $500,000 for a clinical trial using stem cells to treat COVID-19, passed the Senate 23-17 on Wednesday.
Sen. Mike Thompson, R-Shawnee and a member of the center’s advisory board, said the treatment would target end-stage COVID inflammation “that becomes so severe that about the only thing you can do is put the patient on a vent, and hope and pray.”
“This would give those end-stage severe COVID patients an option for therapy and could save many, many lives,” he said. “Had this therapy been developed when they first asked for the money, we could have intervened in a lot of these cases.”
Gov. Laura Kelly, a Democrat, line-item vetoed a similar provision in last year’s budget. She urged a focus on vaccination.
“We should listen to those with knowledge of how clinical trials work when they tell us that the proposal outlined in this proviso is unrealistic and unneeded, and we should focus on saving lives by expediting vaccinations for as many Kansans as possible throughout the state,” Kelly said at the time.
Officials at the University of Kansas Medical Center and its stem cell center haven’t explicitly supported the proposal.
“While we appreciate the efforts of the advisory board and the Senate Public Health and Welfare committee’s interest in supporting the Midwest Stem Cell Therapy Center, we continue to have logistical concerns with the bill,” said Natalie Lutz, a KU Med spokesperson, in a Monday email.
When KU officials raised concerns about the “relatively short timeline” to expend the money, senators twice responded by extending the bill’s end date. Legislators said that should also address a secondary concern from KU that declining COVID-19 case numbers could affect their ability to enroll enough patients for a trial.
A successful trial would need U.S. Food and Drug Administration approval, to produce cells, enroll patients and complete a follow-up. School officials estimated the process would take two to three years.
The original bill called for a June 2022 deadline. A new deadline is in 2024.
Thompson said the date change addressed the concern that a trial would take longer than lawmakers anticipated. But the new date doesn’t appear to have secured the support of KUMC leadership.
“This bill is not an approved priority for the Kansas Board of Regents; therefore, the medical center remains neutral on this issue,” Lutz said Wednesday.
Lutz said KUMC leadership “appreciate” the amendments, which “increases the likelihood that we will complete a meaningful trial within the timeframe specified.” She said researchers want to use state funding wisely and “we look forward to clinical trial development and continuing research that makes a difference in the lives of Kansans.”
“Clinical trials are an important part of that research and exploring investigative stem cell treatments for COVID-19 is a part of the center’s plan,” Lutz said.
Despite raising concerns, KU officials didn’t explicitly oppose the funding, leading to confusion among lawmakers. Multiple senators made conflicting claims about the position of administrators.
“I can assure you that the director of the Midwest Stem Cell Therapy Center is in favor of this funding,” Thompson said.
“I certainly would not minimize the testimony from the director,” said Cindy Holscher, D-Overland Park. “Because if this really were a good idea, there would be a lot more enthusiasm.”
“It’s horrifically distressing that the director of this center stands in the way, and there’s political reasons that this person stands in the way,” said Sen. Mark Steffen, R-Hutchinson.
In addition to Thompson, two other advisory board members testified in support of the bill.
David Prentice chairs the advisory board. He is also a Charlotte Lozier Institute researcher and professor of molecular genetic at The Catholic University of America.
James Sherley is a physician-scientist and advisory board member. He is president and CEO of Asymmetrex LLC, a stem cell biotechnology company.
Testimony from the center’s leadership appeared to contradict the advisory board.
University of Kansas Medical Center executive vice chancellor Robert Simari and center director Sunil Abhyankar submitted neutral testimony calling a clinical trial unfeasible in the legislation’s initial timeline.
But they offered no comment on whether they would support the bill if it offered more time for the research.
Advisory board members say the stem cells could be used to treat the so-called cytokine storm of inflammation that affects severe COVID-19 cases. A previous KU study saw success with using mesenchymal stem cells to treat graft versus host disease by targeting the cytokine storm.
Prentice said the advisory board brought the issue to the Legislature because researchers already have “proof of principle that this should work, and there being nothing else you can do for these particular patients.”
He said told the Senate Public Health and Welfare Committee he was unaware of the concerns raised by KU administrators. Prentice said the center “has a clinical research protocol ready to submit to the FDA.”
Thompson was the legislator who first introduced the bill. He said officials at the center approached him to secure the funding, later clarifying that it was the head of the advisory board and several board members.
Sen. Pat Pettey, D-Kansas City, said there is no evidence that center leadership supported the bill, despite advisory board lobbying. She questioned whether researchers had a plan in the works, noting the apparent internal conflict.
“When a director of a center says they can’t do something within the timeframe that’s established, and we in turn say we’ll just stretch it out for two more years, that then is in essence saying we want you to do this regardless of whether this was actually in the plans,” she said.
Pettey said legislators are now making decisions on what research happens at the center.
“We’re inserting ourselves into this medical decision here by saying we’re going to give you some money, will you do this,” Pettey said. “In fact, that seems to be not the route that we really want our medical organizations or any of our organizations across the state to be working.”
Thompson maintained that the center itself was requesting the bill, pointing to a note in its 2022 annual report indicating a plan to obtain funding for a stem cell trial related to COVID and pulmonary complications needing intensive care.
Sen. Renee Erickson, R-Wichita, noted that embryonic stem cells are not used in the research.
During a committee meeting, Sen. Kristen O’Shea, R-Topeka, called it “odd” that KU officials “didn’t say we’re thrilled to have extra funding, but it sounds like they were OK if the dates change.”
Steffen is an anesthesiologist who has promoted unproven and potentially dangerous off-label drugs for COVID-19 treatment and prophylaxis. He has publicly said he is under a state health board investigation dating back to the early days of the coronavirus pandemic.
More: Kansas bill would force pharmacists to fill ivermectin, hydroxychloroquine as off-label COVID treatment
He supports the stem cell research.
“The bottom line is mainstream health care has abdicated the responsibility of developing treatments,” Steffen said. “That starts in the early treatment, middle, late and long. What this bill is is a treatment for middle COVID, when the inflammatory stage starts.”
In committee, Steffen argued that the money was a better investment than advertising vaccines.
“This is a small expense when compared to the billions and even trillions of dollars that have wasted in response to this virus that have achieve nothing,” he said on the Senate floor.
Pettey disagreed.
“It’s putting money into a place that we really have no request for or any understanding … about how it might be used,” she said. “But when it comes to the stem cell therapy center itself, they’re not in direct support of it.”
Sen. Beverly Gossage, R-Eudora, said a cousin who had long-haul syndrome died in the past week after experiencing additional health problems due to the condition. She suggested the stem cell research could help treat long-haul COVID after reading of a possible HIV cure using stem cells.
More: Woman possibly cured of HIV using novel but rare treatment, researchers say
Holscher said clinical trials typically determine timeframes and necessary steps in advance.
“We’re missing some important components here,” she said.
“It almost feels like this bill is about something else. There are a lot of things that just don’t match up and some oddities here.”
Thompson said the dollar amount was based on a 10-patient clinical trial with a presumptive cost of $50,000 per patient, based on an American Medical Association study.
Thompson said no other facility in the U.S. is conducting similar research, and “there’s only a couple places in the world doing it.”
Sen. Jeff Pittman, D-Leavenworth, admitted that he doesn’t know the medical research industry, but questioned whether it is a good use of taxpayer dollars and if the government is subverting private industry.
He also questioned why other people haven’t seen a potential to develop a helpful treatment with an opportunity for financial gain.
“It sounds like a good thing to be the unique, cutting-edge research on technology that can advance our Kansas businesses, for sure,” Pittman said. “However, it gives me pause. I don’t know enough about this to understand whether we should be investing this money in this type of endeavor if we’re the only ones in the world doing it.”
Thompson called it “groundbreaking research” that “has proven effective” for another inflammatory disease.
“It has the potential of being something coming out of Kansas that could help patients now and in the future in a very short amount of time,” he said.
Jason Tidd is a statehouse reporter for the Topeka Capital-Journal. He can be reached by email at jtidd@gannett.com. Follow him on Twitter @Jason_Tidd.

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