Bridging the translational gap: Ex vivo efficacy testing of a scalable stem cell-derived amniotic cell therapy for wound healing

The amnion is an epithelial tissue that forms a protective membrane surrounding the developing embryo and produces growth factors, cytokines and hormones. Amniotic epithelium is induced from unspecialised cells very early during development. The initial amniotic cells to be produced are highly proliferative; however, this proliferation rate slows at later stages of development. Amniotic membrane is an ideal source for tissue engineering and cell therapies because of its inherent anti-inflammatory and immunomodulatory properties, ability to induce epithelialisation and promote tissue repair, and lack of tumorigenicity. Amniotic membranes collected from term placenta have been successfully used in patients to treat burns and wounds and for ocular surface reconstruction. However, current amniotic cell products are sourced from donated placentas from caesarean sections, which causes substantial supply limitations, variability, and regulatory restrictions, as well as being expensive to manufacture. These constraints prevent the broader adoption of amnion-based therapies despite their established clinical benefit. There is thus a pressing need to identify improved sources of human amniotic epithelial cells, and to develop new methods to generate large numbers of standardised amniotic epithelial cells in vitro. Human pluripotent stem cells (hPSC) are the laboratory-grown counterparts of early embryonic cells. We have developed a robust method for the directed differentiation of hPSC to human amnion-like epithelial cells (hALEC). We have demonstrated that hALEC possess similar properties to placental-derived amnion including extracellular protein expression, growth factor production and anti-inflammatory properties. Importantly, hALEC are functionally active and promote wound healing of human skin cells in vitro. Our hALEC technology, termed AmnioCam, addresses a critical biomedical challenge by offering a reliable, unlimited, and standardised source of amniotic cells for research and clinical applications. This innovation has the potential to transform treatments for acute and chronic wounds, corneal repair and surgical scarring. By eliminating reliance on placental donations, this method paves the way for more accessible and reproducible amnion-based treatments globally. We aim to bring AmnioCam to market through a new UK-based spinout. Informed by ICURe Explore outcomes and participation in ICURe Exploit, our strategy focuses on licensing partnerships, strategic investment, and co-development deals with wound care companies. Strong interest from clinicians and commercial partners indicates high potential for early adoption via translational research partnerships and clinical trials supported by grants or investments. Our MRC Gap Fund project seeks to overcome the next major technical high-risk / high-reward step that is required to take AmnioCam forward. We will test our hALEC technology with gold-standard functional assays using ex vivo human skin wound healing models. Obtaining these data will allow us to demonstrate therapeutic potential and functional impact. Successful completion of this work will unlock the next stage of AmnioCam’s translational journey, supporting lead candidate selection, investment readiness, and follow-on funding applications to schemes, such as DPFS, NIHR i4i, and Innovate UK. The proposed work addresses a major unmet need in treating chronic and hard-to-heal wounds, the incidence of which are rising globally, leading to growing demand for reliable, cost-effective, off-the-shelf solutions. This is expected to deliver clinical benefits through faster wound closure and fewer complications, reducing pressure on healthcare systems. Economically, shorter treatments and fewer interventions would lower costs. Societally, improved healing outcomes would enhance mobility and independence, particularly for elderly and diabetic patients. Environmentally, lab-based production offers a more consistent and potentially less resource-intensive alternative to donor-derived tissue.