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A pioneering study using stem cells opens new hopes for dental implant placement.
The results of a trial funded by the European Union through the EU Horizon 2020 program have been published. The trial, published in Clinical Oral Implants Research, has significant Spanish participation, with two Spanish centers—the Complutense University of Madrid (UCM) and the International University of Catalonia (UiC)—along with centers in France, Germany, Denmark, and Norway. Specifically, for the first time, the benefit of a pioneering therapy based on stem cells implanted in a synthetic bone substitute has been documented in patients.
An essay with a Spanish accent
This is a randomized, controlled phase 2 clinical trial, in which the safety and efficacy of a cell therapy with expanded autologous mesenchymal cells derived from the iliac crest, seeded in a bioabsorbable synthetic bone substitute coated with a non-resorbable membrane, has been evaluated.
Professor Mariano Sanz, Chair of the Complutense University of Madrid and Honorary Patron of SEPA, is the first author of this article and a world-renowned expert in this field. “Our group has been researching the potential of this therapy for years, both in the laboratory and in animals; therefore, it is a logical consequence that when the opportunity arose to use this alternative in patients, we were pioneers,” explains this expert, who is part of the Research Group on Etiology and Therapy of Periodontal and Peri-implant Diseases (ETEP) at the Faculty of Dentistry of the Complutense University of Madrid.
This research group has spent many years investigating the effectiveness of various surgical interventions and suitable biomaterials for bone regeneration in jawbone defects that prevent or hinder implant placement and, consequently, the rehabilitation of teeth lost by our patients. This is a problem of growing research and clinical interest.
A major problem
When these bone defects are small or moderate, current technologies offer very good predictability and the results are very positive. However, in large defects, when three-dimensional reconstruction of the maxillary or mandibular bone is required, current techniques do not provide very predictable results and depend heavily on the surgeon's skill.
The importance of this newly evaluated approach lies in the need to find new solutions for rehabilitating the missing teeth of these patients who, in some cases, face significant limitations in the placement of dental implants due to a substantial bone defect. “With these advanced therapies, such as stem cell therapy, we aim to stimulate the bone so that it can rebuild its three-dimensional structure and, in this way, allow the placement of dental implants in their ideal position. Once they integrate with the bone, the appropriate prostheses can be placed to restore the function and aesthetics of the missing teeth,” explains Professor Sanz.
An innovative study
The published article reports on the “favorable results obtained.” A total of 48 patients were included and randomized (36 patients in the test group and 12 in the control group). As this was a clinical trial, the effect of the proposed advanced therapy (stem cells implanted in a synthetic bone substitute) was compared to the most commonly used regenerative bone therapy for reconstructing this type of defect, which involves using a bone block taken from the posterior ramus of the patient's own mandible.
The results, published in ‘Clinical Oral Implants Research’, demonstrate a significantly greater three-dimensional bone reconstruction in the cell therapy group, with gains in cubic millimeters of bone almost double that of the control group.
What does this mean?
As Professor Mariano Sanz explains, “Our results are difficult to translate directly to clinical practice, since cell therapies, both in our field and in other medical fields, are highly restricted, primarily due to regulatory barriers.” Naturally, national medicines agencies must ensure that cell manipulation is carried out under optimal safety conditions for patients, and this is still only done in a few centers and at very high costs. However, the professor from the Complutense University of Madrid adds, “These results open an important door for further research into technologies that optimize cell manipulation and, therefore, facilitate its use and reduce current costs.”
Synthetic substitute
This trial is part of a project funded by the European Union through the EU Horizon 2020 program. These projects support consortia of universities, institutions, and industry that undertake a specific project. In this case, the project involved the reconstruction of atrophic jaws using cell therapy with autologous stem cells (from the patient themselves), obtained through a puncture in the iliac crest (hip bone).
A key aspect of this proven approach is its reliance on a synthetic substitute, with all the associated benefits. “The great advantage of a synthetic substitute is that it doesn't require a source of natural bone, whether animal or human, which makes it more readily available and more sustainable. Furthermore, these new synthetic substitutes allow for industrial manufacturing with the ideal physicochemical characteristics for bone regeneration,” explains the lead researcher.
In this case, the synthetic substitute is a scaffold that allows space to be maintained so that the bone itself, stimulated by the biological effect of the implanted cells, can enter the porous structure of the substitute, which is eventually reabsorbed, and be replaced by native, living, and functional bone.
This is just the beginning
Based on these findings, many options are now being considered to further advance in this field. “The technologies for isolating, identifying, and growing mesenchymal stem cells must be improved to make their use more affordable,” this expert points out. Furthermore, alternative cell therapies using allogeneic cells (from a bank, rather than the patient's own cells) are being tested. And that's not all. “We are also investigating cell-use strategies without implanting the cells themselves, that is, by implanting the product of their secretion (secretome), which retains most of their biological properties; in this way, we avoid most of the regulatory barriers to cell therapies,” explains Professor Sanz. In fact, they have just applied for a new major European research project seeking to validate this new strategy, which “can provide the same excellent results with less morbidity for the patient (it will not be necessary to extract their stem cells), lower cost, and fewer regulatory barriers.”