Doctors currently have no reliable way to see where transplanted cells go once inside a patient’s body. This research aims to fix that by engineering better nanoparticle labels that make those cells visible on MRI and other scanners, so clinicians can tell whether the cells have settled where they should—or drifted into dangerous locations. Regenerative medicine therapies—using living cells to repair damaged tissue after stroke, heart attack, or organ failure—are entering human trials. But regulators and companies cannot approve them without knowing whether the cells stay put or spread to unintended organs, where they could cause unknown side effects. Existing tracking methods lack the sensitivity to answer that question. This project will develop nanoparticles that are brighter, more stable, and safer inside cells than anything currently available, then test them in rodent models of liver and kidney damage. If successful, the work will produce a standardised “roadmap” pairing the right label with the right imaging technique for any regenerative therapy. That would give regulators, drug companies, and clinicians the confidence to move these treatments into patients faster, without compromising safety.
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Context of the Research The emerging field of Regenerative Medicine Therapies (RMTs) has the potential to transform medicine and provide treatments and cures in areas of unmet need that are intractable to current practice. There are growing numbers of clinical trials in areas as diverse as stroke, heart disease and cancer. However, with all emerging technologies, there are a number of barriers that need to be addressed, one of which is safety. The focus of our research programme will be to provide a clearer understanding of the potential hazards (and associated risks) with RMTs, so that scientific stakeholders (academics, clinicians, pharmaceutical companies, biotechnology companies, regulatory authorities) are able to accelerate these new medicines into the human population with full confidence. Of particular importance, is the need to be able to monitor and track cells when they are transplanted into patients to assess whether any of the cells take residence in inappropriate areas of the body. This is essential because inappropriate distribution of RMTs could lead to unknown (and potentially serious) side effects. However, current methodologies used to monitor the biodistribution and behaviour of transplanted cells over time are not capable of providing the sensitivity or specificity required. Certain types of labels that show promise in tracking RMTs are nanoparticles which act as contrast agents for different imaging techniques (such as magnetic resonance imaging, MRI) and a number of these nanoparticles have been approved for clinical use. However, they do not currently display the necessary characteristics for the sensitivity that is required to track transplanted cells. The new technologies we need have to be developed in a way that ensures that they are accepted by the professionals in industry and the health service who will be responsible for deploying them. Our project therefore features an ongoing detailed dialogue with these stakeholders to define the hazards associated with regenerative medicine therapies and gain acceptance for the protocols we will develop to ensure these therapies are safe. Aims and Objectives 1. We will engineer long-term stable nanoparticles with superior signal intensity, uptake behaviour, stability and retention to the current commercial benchmark 2. We will evaluate these nanoparticles in laboratory tests to ensure that, once they are introduced into human cells, they do not cause damage or change in function to the cells. 3. Labelled cells will then be tracked in rodent models of liver or kidney damage using a collection of cutting-edge imaging techniques to determine a) the most appropriate imaging technique to use; b) the sensitivity of the labelled cells and; c) where the cells are distributed in the body 4. With a clearer knowledge of distribution of the introduced cells (the hazard), we will be able to evaluate potential safety risks. 5. Using different transplanted cells, different imaging techniques and improved cellular labels, we will define a generic roadmap for the most appropriate label/imaging combination that should be used to evaluate RMT biodistribution. 6. We will work with a commercial partner to progress the best nanoparticle into formal development so that it will be ready for downstream clinical applications. Potential Applications The Safety Hub will, for the first time, provide a clear framework for the most appropriate label and imaging technology to use for robust safety assessment of RMTs. The benefits will be felt by beneficiaries involved in the development of novel RMTs that will ultimately lead to acceleration of these therapies into a clinical setting.
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