Umbilical cord stem cells against atrophic macular degeneration in the elderly. The new technique was developed by researchers at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS and aims to slow down the evolution of age-related atrophic macular degeneration. Subretinal injections of a product derived from umbilical cord blood have in fact proven capable of slowing down the evolution of this condition, which is still untreated and can lead to vision loss. In Italy, a few million people over 50 suffer from it.
Eye health, attention to maculopathies by Sandro Iannaccone 11 October 2023 ‘Atrophic’ macular degeneration (dry or elderly), is one of the most frequent eye pathologies in the industrialized world in the over 50s and can lead to complete loss of vision in the center of the visual field. It affects a few million Italians in various stages of severity, while estimates for 2050 predict that 280 million people worldwide will be affected by this pathology. The ‘dry’ form represents 90% of all age-related degenerative maculopathies and to date has no authorized treatment in Europe.
In short, given the spread of this disabling pathology, there is a serious gap in treatment. At Gemelli we are therefore trying an innovative path, described in a very recent publication on Opthalmology Sciencewhich exploits the regenerative capabilities of umbilical cord blood.
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“Atrophic degeneration is a very common and disabling pathology in the elderly, for which there is currently no treatment in Europe – explains the professor Stanislao Rizzo, Director of the Ophthalmology Unit of the Gemelli Polyclinic Foundation and full professor of Ophthalmology at the Catholic University -. We therefore had the idea of using a derivative of umbilical cord blood, platelet-rich plasma (PRP). We are the first in the world to have had this experience and the one just published is our phase 1 study.”
“In this first phase of our research – explains the doctor Maria Cristina Savastano, of the Ophthalmology Unit of the Fondazione Policlinico Universitario Agostino Gemelli IRCCS, responsible for the study design – we first evaluated the safety of the procedure, consisting of the sub-retinal injection of PRP from umbilical blood. This is not a simple procedure, to be entrusted to expert hands (at Gemelli it was carried out by Dr Alfonso Savastano and the teacher Rizzo), which cannot be repeated too frequently. Therefore, we immediately designed a parallel intra-vitreal administration protocol, much easier to perform and safer, which has already been underway for a year.”
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“The product used in this study – explains the professor Luciana Teofili, Director of the Blood Transfusion Unit of the Gemelli Polyclinic and Associate of Blood Diseases at the Catholic University – is plasma enriched with growth factors and soluble mediators contained within the platelets. We use the units donated to the Umbilical Cord Bank (of which Dr. Maria Bianchi is responsible), which cannot be frozen for transplant purposes. After separating the concentrate, the platelets are concentrated and subjected to a thermal shock (repeated freezing and thawing processes), which leads them to release a series of precious growth factors into the plasma, which are added to those already present in the plasma. fetal plasma. To limit the variability of these products, pools of various units are set up and their sterility is tested several times through culture tests for bacteria and fungi”. The use of PRP from adult blood has long found application in the treatment of diabetic ulcers, orthopedic degenerative processes, in cosmetic surgery, in dermatology, etc. The use of cord PRP in the ophthalmology field is much less widespread. Given the expansion of the fields of use of cord blood, the invitation is to always donate the cord at the time of childbirth.
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“The administration of this blood component – says Professor Rizzo – will probably have to be repeated on a monthly basis, every two months or every three months because from the study just concluded we have highlighted that the arrest of the extension of the atrophy is achieved only for 1-3 months, after the administration of the blood product”. Of course, if the ongoing studies (those with intra-vitreal administration) demonstrate good efficacy, this could be Columbus’s egg for patients, albeit a low-cost one. “We have filed in the USA the patent for the intra-ocular use of pools of PRP from umbilical cord blood – continues Professor Rizzo – further confirming that we were the first to have the idea of a preparation of this type (the pool’ and the route of administration)”.
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What can be done today for dry macular atrophy. For the treatment of this condition, two drugs have recently been approved in the USA, belonging to the category of complement cascade inhibitors. The intraocular treatment is carried out on a monthly or bimonthly basis for an indefinite time; in the USA a vial costs around 3 thousand dollars. However, the EMA has not yet given the OK to these drugs. “In fact, the registration trials – explains Professor Rizzo – demonstrated a slowdown of the pathology (and not an improvement, much less a cure) in only 30% of the treated population. Furthermore, these results are related to anatomical data, which demonstrated how the the area of atrophy increased less in the treated group compared to the control. But the European regulatory body (EMA) requires functional results (i.e. the demonstration of an improvement in vision or a significant slowdown in its deterioration); therefore, companies will probably have to propose a further study to the EMA, on ‘functional’ endpoints, but this will significantly lengthen the approval times”.