Regenerative medicine aims to repair, augment, replace or regenerate damaged or diseased human cells, tissues, genes, organs or metabolic processes, to restore normal function. The field has seen exciting innovations, including stem cells being used in the treatment of Parkinson’s disease, a heart valve capable of growing in vivo, and genetic therapies used in wet age-related macular degeneration (AMD). These therapies aid in overcoming problems with current therapies as well as tackling age-related diseases.
Biodegradable heart valves
Heart valves may require replacement for several reasons, such as valve stiffness or leakage. The procedure typically involves the use of either a synthetic or a biological valve, each with its respective disadvantages. Synthetic replacement valves necessitate the lifelong use of blood-thinning medications, while biological valves, often derived from pigs or cows, tend to wear out and need replacement every 10 to 15 years.
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A groundbreaking application of nanofibrous biodegradable polymers has led to the creation of a heart valve scaffold. This technique, developed by Sir Magdi Yacoub and his team at Harefield Hospital in Cambridge, England, and Imperial College London, addresses the limitations of traditional methods by offering a biological solution that does not require subsequent replacement. Once implanted, the scaffold attracts cells that develop to regenerate tissue which functions as a valve, while the polymer gradually degrades. This innovation has demonstrated efficacy in animal studies, including trials with sheep that have shown functionality over six months.
The next step is to conduct more extended animal studies. If these prove successful, the approach could advance to human trials and eventually be applied to various conditions. This method has the potential to significantly reduce the number of surgeries for patients who develop heart conditions early in life. It also offers more options to patients between the ages of 65 and 75, the average age for a replacement, who may not be candidates for blood-thinning medications and who could be at a greater risk for health complications from surgery in the subsequent 10 to 15 years.
Stem cells in Parkinson’s disease
Parkinson’s disease is an age-related condition commonly attributed to the degeneration of dopamine-producing neurons in the brain. This deterioration leads to symptoms such as tremors, slow movement and cognitive impairment. GlobalData’s Parkinson’s Epidemiology Analysis and Forecast to 2023 indicates that Parkinson’s disease cases will rise from 2.64 million cases in 2023 to 3.15 million cases in 2033 in the seven major markets (France, Germany, Italy, Japan, Spain, the UK and the US).
At present there is no cure for the condition, but most patients receive medication that elevates dopamine levels in the brain to mitigate symptoms. Nevertheless, as neurodegeneration progresses, these medications become ineffective due to the neurons’ diminished capacity to absorb the pro-drug and produce dopamine.
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By GlobalDataApplications of stem cells in regenerative medicine have become increasingly promising due to advancements in understanding their capabilities. In February 2023, the inaugural patient in the STEM-PD trial underwent a transplant of stem cell-derived dopamine cells to regenerate these neurons. The initial phase of the trial exhibited encouraging safety data and indications of the transplanted dopamine cells surviving for six to 12 months post-transplantation. The trial has advanced to administering higher doses, which were implanted in four patients in 2024. These individuals will be monitored over three years.
The application of stem cell transplantation signifies a pivotal advancement in Parkinson’s treatment. This technique holds the potential to alleviate the concern of treatment-resistant Parkinson’s disease among patients, ultimately leading to a significantly improved quality of life.
Gene therapy in wet AMD
Age-related macular degeneration (AMD) primarily affects the central area of vision rather than the peripheral, complicating tasks such as reading and driving. It typically first manifests in individuals in their 50s or 60s, and without treatment, a patient’s vision will continue to deteriorate. There are two forms of AMD: wet and dry. Wet AMD, though less common, results in more rapid vision loss characterised by the build-up of fluid in areas of the eye. Dry AMD may also progress to the wet form. Treatment for wet AMD often involves regular injections into the patient’s eye, which many find distressing.
Adverum Biotechnologies has developed a regenerative gene therapy, ixo-vec, designed to address the abnormal blood vessel growth beneath the retina characteristic of wet AMD. This innovative therapy offers the advantage of requiring only a single dose, thereby eliminating the need for monthly injections. In November 2024, Adverum announced encouraging results from its phase II clinical trials and anticipates initiating phase 3 trials in the first half of 2025.
Regenerative medicine is an exciting field, capable of tackling inherent challenges seen with current therapies, shown by all three innovations. These advancements mean that regenerative medicine can be used in the battle against age-related degenerative diseases such as Parkinson’s and AMD.
