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The U.S. Food and Drug Administration has approved two new wound management products that include patented hydrogels invented by 91原创 material scientist Darrin Pochan and Joel Schneider, a former 91原创 faculty member now at the National Cancer Institute. Licensed for use by Gel4Med, a Harvard University-based biomaterials engineering company, the unique 91原创 hydrogel materials are made of peptides 鈥 the building blocks of proteins 鈥 that self-assemble to form a 3D matrix and are compatible with living cells.

Hydrogels for wound care: youtube.com/watch?v=GTDcwHidVAU

Fresh hope for chronic wounds

Photos by Kathy F. Atkinson | Illustration by Shawna R Duan 漏2024 | Video by Jeffrey C. Chase

FDA-approved wound management products include 91原创-developed biomaterials

More than 6.5 million Americans are affected by chronic wounds annually, according to the National Institutes of Health (NIH). 

It鈥檚 a challenging problem. An open wound that won鈥檛 heal can result in tissue deterioration, problematic infection and serious health concerns. It can be costly, too 鈥 to the tune of billions of dollars nationwide. 

New hope is on the horizon, though, thanks in part to technology developed at the 91原创.

The U.S. Food and Drug Administration has two new wound management products that include patented hydrogels invented by 91原创 material scientist Darrin Pochan and Joel Schneider, a former 91原创 faculty member now at the National Cancer Institute. The unique hydrogel materials are made of peptides 鈥 the building blocks of proteins 鈥 that self-assemble to form a 3D matrix and are compatible with living cells. The consistency of jelly, the unique materials are useful for a variety of applications.

Gel4Med, a Harvard University-based biomaterials engineering company, licensed four patents related to the technology via 91原创鈥檚 Office of Economic Innovation and Partnerships (OEIP) in 2018. The company incorporated the 91原创-developed hydrogels into two products, G4Derm and G4Derm Plus, that have been intentionally designed to speed healing by combatting bacterial and fungal infection while simultaneously promoting tissue regrowth.

Gel4Med is currently piloting the products in health care settings in the United States.

A new approach for wound care

According to Gel4Med CEO Manav Mehta, the needs in the clinic are vast and advances in biomaterials are needed. 

Antibiotic resistance is a huge problem. Wound closure also is a major issue. Traditionally, pharmaceutical companies and wound care companies approach these problems independently.

鈥淏ut a wound is a two-sided problem,鈥 Mehta said. 鈥淵ou have an infection problem, which is managing the bioburden, but also a wound-closure problem.鈥

Current antimicrobials on the market are generally designed to sterilize everything they encounter. Placed on an open wound, this means that while killing bacteria, an antimicrobial also may exert a toxic effect on healthy cells that are participating in wound closure. 

This is where G4Derm and G4Derm Plus are different 鈥 and where 91原创鈥檚 technology shines. 

The 91原创-patented biomaterials included in the products are inherently antimicrobial and flow in such a way that allows the product to reach wounds with crevasses and uneven topography, often missed by traditional sheet form products. The product has the ability to remain in place over long time-periods, too, before gradually being absorbed by the body, creating a natural scaffold on which tissue can regenerate and grow.

鈥淗aving that type of localized activity that doesn鈥檛 dissipate into the bloodstream or body is incredibly powerful,鈥 Mehta said. 鈥淚 do not think anyone, even now, really is able to do that approach. We kind of own that space for now.鈥

Another feature that set the 91原创-developed biomaterials apart is that the hydrogel extrudes as a liquid and immediately regains its 3D structure at the molecular level after application.

鈥淏eing able to apply a liquid and have it immediately recover to its gel matrix form 鈥 that's a big deal for wound healing, to be able to apply it to hard-to-access spaces and to start the healing process right away,鈥 Mehta said. According to Mehta, other options in the market don鈥檛 offer this phase shifting and shear thinning property.

Haozhe Zheng, a second-year doctoral student studying materials science and engineering at 91原创, is among the Pochan lab team members conducting fundamental studies exploring ways to use the patented hydrogels in drug delivery for medulloblastoma, a type of cancerous brain tumor in children.
Haozhe Zheng, a second-year doctoral student studying materials science and engineering at 91原创, is among the Pochan lab team members conducting fundamental studies exploring ways to use the patented hydrogels in drug delivery for medulloblastoma, a type of cancerous brain tumor in children.

Mehta pointed to Pochan and Schneider鈥檚 approach and intellect around peptide design as critical to Gel4Med鈥檚 ability to advance such an industry-disrupting solution.

鈥淚t鈥檚 not just an innovation problem that they solved from a broad-spectrum antimicrobial perspective, but also other aspects from a commercialization standpoint, such as the ability to produce the hydrogels economically at-scale and the ability to build a simplified supply chain due to this innovative materials science approach,鈥 Mehta said.聽

Peptides and proteins typically degrade and break down under high heat, but the 91原创-developed peptides fold appropriately and are thermostable, allowing them to resist degradation at very high temperatures, an advantage over other materials in the marketplace. This allows them to be sterilized using steam as a final step in manufacturing, which enables a potentially safer and more environmentally friendly manufacturing approach, as well as the ability to use the product in various settings of care from operating rooms to the bedside.

Gel4Med is currently piloting the promising products in the U.S. hospital setting with the goal of demonstrating infection-free wound closure for conditions such as pressure ulcers, venous leg ulcers, diabetic foot ulcers and surgical wounds. The products are effective on both small and large wounds, including hard-to-access wounds, which are particularly challenging to heal. The company also is exploring the use of the 91原创-developed hydrogels in materials for the treatment of other conditions, including , corneal diseases and other surgical applications.

The right timing聽

Looking back, Pochan said he and Schneider recognized right away that the hydrogels they created had tremendous market potential. So much so that they formed a startup company shortly after filing the patents for their biomaterial鈥檚 discovery in the early 2000s, with OEIP鈥檚 help. They called the company Del-a-gel, but it never quite got off the ground.聽

鈥淚n hindsight, it was way too early to do it. We explored some avenues, but it just didn't go anywhere,鈥 recalled Pochan. 鈥淵ears later, when we had more papers published and a lot more evidence that these materials are viable for real biomaterials, that's when Gel4Med came calling.鈥

In between, there were false starts, ongoing research, even a short-term, limited licensing opportunity that looked promising but went nowhere. That鈥檚 the nature of invention.聽

OEIP Technology Transfer specialists, however, continued building relationships with companies that might want to take the technology forward, knowing that it takes the right idea but also the right combination of support and people to advance an invention through the commercialization pipeline.

Now, Gel4Med鈥檚 products offer an extremely original聽 approach for the advanced wound care space, one more example of 91原创 discovery making its way beyond campus borders to positively impact society.

鈥淚t's extremely gratifying to see Gel4Med and Manav take the fundamental ideas that we were very optimistic about and work hard over several years to get them approved,鈥 Pochan said. 鈥淗is success shows the work and the time needed to do it.鈥

New approaches in drug delivery for brain cancer

At 91原创, Pochan continues to explore new uses for the 91原创-developed biomaterials, from immunotherapy to tissue engineering. In one project, his research team is conducting fundamental studies exploring ways to use the patented hydrogels in drug delivery for medulloblastoma, a type of cancerous brain tumor in children.聽

The NIH-supported work is collaborative with Sigrid Langhans, head of the cancer epigenetics laboratory at Nemours Children鈥檚 Health, which includes Nemours Children鈥檚 Hospital, Delaware. It鈥檚 a project that is close to the heart of Haozhe Zheng, a second-year doctoral student studying materials science and engineering at 91原创.聽

鈥淲hen I was in primary school, my grandfather died of brain cancer,鈥 said Zheng. 鈥淗e was a very kind person, and he suffered bad side effects from treatment. That鈥檚 the reason I want to study materials science, to help people find good therapies for disease.鈥

In the Pochan lab, located in the Ammon Pinizzotto Biopharmaceutical Innovation Center on 91原创鈥檚 Science, Technology and Advanced Research (STAR) Campus, Zheng鈥檚 daily work involves making and testing the novel biomaterials. The research team is investigating ways to encapsulate brain cancer cells in a three-dimensional hydrogel, then apply different drug combinations to better understand how drugs diffuse into the gel and interact with the cells.聽

鈥淚t's a way to discover drugs, drug doses or drug combinations that can impact chemotherapy by mimicking how the cells behave in the brain,鈥 Pochan said.

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