Biomaterials
report found that alginate hydrogels, already widely used in medicine, had shown promise in a wide array of regenerative niches. Such studies have shown there has been some success in such materials being used in blood vessel growth, bone marrow growth, cartilage repair (one of the leading causes of disability), as well as nerve and muscle repair. As authors in another paper – ‘The Usages and Potential Uses of Alginate for Healthcare Applications’ – conclude: “Since alginates are promising in the field of tissue engineering due to their biocompatibility with human tissues, they are now extensively used in the control and regeneration of tissues in medical fields.” A separate 2021 journal article in SN Applied Sciences laid out where alginates might have limitations in tissue engineering, though. Alginate hydrogels are only slowly degradable in vivo and typically require chemical modification or enzymatic treatment to achieve controlled degradation. Elsewhere, alginate doesn’t promote healing in and of itself. “While alginates are excellent for wound management, a key limitation is that they are not considered bioactive, meaning they don’t actively accelerate the healing process itself,” says Warde. Although there is hope these limitations can be rectified – by additional material or manufacturing, such as the use of ceramics (to build artificial bone) or peptides (for cartilage) – to improve cell proliferation and adhesion, the paper concludes that alginate alone cannot meet all design requirements (mechanical strength, degradation rate, bioactivity) needed for tissue engineering. As Warde says, it might mean looking elsewhere: “Our innovation strategy is increasingly focused on developing active materials that can help push a wound towards healing.” This is not to say authors weren’t optimistic about future uses. The use of 3D bioprinting can control scaffold structures, and there is optimism about smart hydrogels and porous scaffolds for delivering nucleic acids such as siRNA and DNA. It’s hardly like the material itself is the only metric by which suitability is adjudged. Indeed, increased use of alginates will also play out on the ecological agenda, of which there is pressure on the scientific community to adhere.
Ecological alginates
$531.7bn The estimated
global regenerative medicine market’s worth by 2033.
Allied Market Research 82
Like other industries, there is demand for the scientific community to build ecological, bio-inspired and hybrid materials. And, as laid out by research, the cultivation and harvesting of algal matter can be green. For one, it is possible to grow algal matter in a wastewater treatment centre, combining necessary farming with environmental remediation. There are also ecologically friendly extraction phases, such as microwave-assisted extraction, which reduces solvent use and shortens processing time in alginate manufacturing.
Elsewhere, in biosensing – alginates can be used to detect heavy metals and bacterial pathogens, as well
as glucose or for conditions like inflammation or ischemia – algal-based matrices can be used to pioneer a greener alternative to synthetic sensor substrates. While synthetic polymers derived from petroleum sources formerly used in some skin graft and orthopaedic implant materials can be replaced by marine or brown algae, offering upsides such as biocompatibility and mechanical properties without toxic give-off.
This is of interest to alginate-using medical providers. For one, Warde explains, using alginates aligns with commitments to responsibly source and develop products. “[Our] cross-functional global team evaluates health and safety, materials compliance and environmental attributes – including human health and environmental toxicology – when assessing product characteristics,” he says. Alginates, theoretically at least, tick the right green boxes.
Regulation pathway
And when it comes to regulation, alginate used as a food ingredient is recognised by the US Food and Drug Administration (FDA) as Generally Recognized As Safe (GRAS) for human consumption. Its use in wound dressings derives from medical device approvals rather than GRAS status. Broadly, any tissue engineering medical product (alginate or otherwise) must be filed with the FDA to show safety and effectiveness. However, if alginate scaffolds themselves are generally uncontroversial, regenerative medicine applications may involve ethical considerations surrounding stem cell use. The medical device company (promoting the alginate scaffold) would also have to undertake the administrative programme: detailing the material, showcasing trials, as well as pointing out in the market where there are similar devices that may not raise safety or effectiveness issues. As with the FDA, there are similar regulatory bodies worldwide and, even with harmonisation efforts, manufacturers must still meet region-specific rules. In the EU, alginate-based wound dressings are governed as medical devices under Regulation (EU) 2017/745 and manufacturers must lay out a clear purpose, comply with General Safety and Performance Requirements, provide technical documentation and demonstrate safety and purity. It’s undeniably thorough. But there’s a clear case for jumping through multiple, stringent regulatory hoops and not just continued medical effectiveness. “[Alginate] products meet a fundamental need in healthcare for managing chronic [or] exuding wounds,” says Warde, adding that the business imperative to provide for clinicians is clear. “Their established safety profile and reimbursement eligibility in many markets make them an essential part of a comprehensive wound care portfolio, allowing us to support a wide range of patient needs.” ●
www.medicaldevice-developments.com
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