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Optimizing Vision Restoration: Experience with Holoclar Treatment, the Selection of a Qualified Treatment Center, Accessibility to Patients and Outcomes

Cecilia Marinova, Eva Vlkova, Monika Horackova, Magdalena Netukova, Pavlina Skalicka, Graziella Pellegrini, Veronika Sladkova, Martina Losova, Sandra Skvarlova

Moving towards personalized medicine brings the novel challenge of connecting highly specific treatments with the patients who can benefit from them. One such treatment is the cell therapy Holoclar^®, approved for use in adult patients with moderate to severe Limbal Stem Cell Deficiency (LSCD) caused by trauma (burns, chemical burns to the eyes). It takes significant effort and time to establish a qualified Holoclar^® Treatment Center (HTC). The efficacy of an HTC is assessed based upon the number of treated patients. We evaluated new approaches to improving patient access to the HTC and thus commercial sustainability for Holoclar^®.

We mapped new patient pathways and the role of cooperation, networking, coordination among centers and clinical outcomes and focused on the accessibility of Holoclar^® across the country. To allow a higher number of patients to be treated, the team successfully implemented a novel approach, patient-doctor tandem travel to utilize an established HTC.

Nine patients were treated with Holoclar^®, 3 treated patients came from Brno outpatient clinic, 6 patients had previously been treated in other specialized cornea focus centers and traveled to the HTC in tandem with their attending doctor. After one year of follow-up, there was a remarkable improvement in the monitored parameters in all patients.

The involvement of an external surgery team required careful procedure planning and additional administration. As it is shown in the case of Holoclar^® treatment, not only the experts have to be high-skilled and trained, but before the actual treatment can be initiated, the eligible patients have to be identified, evaluated and effectively transferred to the center. Many processes have to be managed and the complexity of this represents a significant barrier to treatment that should not be underestimated. HTC qualification was made possible by the support of the Medasol team facilitating the process and its administration.