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Regenerative medicine is a rapidly growing industry.
already, Dozens of regenerative medicine products Approved worldwide, including cell-, gene-, and tissue-engineered therapies. They range from Breyanzi, Bristol-Myers Squibb’s CAR T-cell therapy for lymphoma, to Kasgevy, a sickle cell disease treatment from Vertex Pharmaceuticals and CRISPR Therapeutics. First ever FDA approval CRISPR-based treatment was implemented in December.
Overall, the power generation market is expected to grow from $16 billion in 2023 to $49 billion by 2028. According to the analysis From Market Sand Market.
Chandan Sen said this is part of a broader shift in the current pharmaceutical industry paradigm, from symptom-focused, mass-produced medicines to individualized treatments tailored to specific people and conditions.
Chandan Sen, Director, McGowan Institute for Regenerative Medicine
Licensed by McGowan Institute for Regenerative Medicine
Sen is director of the McGowan Institute for Regenerative Medicine at the University of Pittsburgh. The institute was founded in 1992 and is what he calls “one of the oldest institutes in the field of regenerative medicine in this country and the world.”
“Today, those of us in the medical field rely heavily on pharmacological interventions,” Sen said. “It’s all going to change in a very big way.”
For example, instead of insulin injections to manage diabetes, regenerative medicine could lead to “a reliable source of insulin produced by the body,” Sen said.
Last year, a team University of Alberta Presented results from preclinical studies showing that treating progenitor cells with anti-tumor drugs inhibits ATK signaling and can generate insulin-producing cells from a patient’s own blood.
“What we’re trying to do here is look beyond the horizon and try to imagine what diabetes care will look like 15, 20, 30 years from now. People. “I don’t think I’ll ever inject insulin again,” Dr. James Shapiro, a professor at the University of Alberta and one of the study authors, said in the paper. press release.
Such changes may result in more than just changes in treatment options.
“With these types of solutions, you’re talking about a different type of manufacturing, a completely different type of regulatory approval process, and a completely different market,” Sen said. “These are completely different sets of scenarios for how health care is delivered.”
cutting edge
Sen took the helm at MIRM in 2023 after leading the Center for Regenerative Medicine Engineering in Indiana and the Center for Regenerative Medicine and Cell Therapy in Ohio. He brought with him a team of more than 30 researchers and laboratory personnel. His move also expands the institute’s reach to include clinical research facilities throughout Pennsylvania and Maryland.
MIRM work today Contains programs For example, the National Institutes of Health-funded Diabetic Foot Consortium is a multicenter network that studies diabetic foot ulcers, and the Critical Limb Ischemia Program is developing cell therapies to help patients avoid amputation. The same is true.
“From now on, you will see…for lack of a better term, body parts sitting in boxes waiting to be reconnected.”
Chandan Sen
Director, McGowan Institute for Regenerative Medicine
Sen is pursuing regenerative medicine solutions that work without stem cells, but he believes they are too unpredictable and inconsistent because only some stem cells are guaranteed to be targeted. thinking. Once those cells leave the controlled environment of the Petri dish and enter the body, they often become “dysfunctional” and even become cancerous, Sen said.
“Stem cells exhibit very high plasticity and are very strong, so injecting them into people is very dangerous because what they become depends very much on the environment,” he said. Stated. “I’m even more excited about technologies that allow us to reuse non-stem cells to replace lost function.”
His team is working on tissue nanotransfection. This is a non-invasive nanochip device that reprograms one type of tissue into another with just a one-second touch and an electric field applied to the body.
“We were able to create new blood vessels (and) new nerve cells,” Sen said of the TNT technology. edison award In 2018.
TNT is rapid and non-invasive, requires no laboratory procedures, and can be delivered at the point of care. Its potential uses include healing burns, reducing diabetic complications such as foot ulcers, treating injured soldiers, and regenerating damaged and diseased tissue.
Major changes in healthcare delivery
Today, Sen says, many regenerative medicine therapies on the market are relatively simple, such as tissue-engineered skin, which provide biological support but do not integrate with the body; He said it was close to “advanced dressing.” Future generations of treatments could be integrated into the body, which would reduce the risk of immune system rejection, Sen said.
“We will see more and more examples of living organisms being used as bioreactors,” Sen said.
Regenerative medicine and tissue engineering company Cutiss is also developing personalized bioengineered human skin grafts that can create multiple layers of skin tissue and grow with the patient. Samples of healthy skin, about the size of a postage stamp, can be bioengineered in large quantities.
“With a stamp, you can give back a carpet of skin,” says Daniela Marino, CEO and co-founder of Cutiss. he told PharmaVoice last year.
company recently announced Positive 1-year follow-up data from a Phase 2 clinical trial of the product in adult and adolescent severe burn patients.
Such techniques could eventually be applied to everything from organs to nerve cells.
“From now on, you’re going to see, for lack of a better term, body parts sitting in boxes waiting to be reconnected,” he said.
These types of treatments will gradually shift the market from treatments that work for most people to treatments that work “in the specific cases in question,” Sen said. .
Sen acknowledged that in addition to the need for new regulatory and manufacturing frameworks, cost will also be an initial barrier.Indeed, in Kasugevi List price $2.2 million And that UK National Institute for Healthcare Excellence It recently said it needed more data before recommending funding for the product.
“We are no longer running in a straight line,” Sen said. “We’re turning a corner. And each time we turn a corner, the benefits are dramatically greater than before, but of course it comes at a high price.”
Sen believes cost is not necessarily a barrier for regenerative medicine products, with “understanding and investment that this is the future.”
“It will never work in a (large) population and that’s the problem. It’s a problem in the early stages that leads to higher costs,” he said. “But…over time, just like everywhere else, those high costs will become lower costs.”
