Abstract
Background To reduce morbidity to cleft patients, new approaches have been developed and here, we report for the first time the use of deciduous dental pulp stem cells (DDPSC) associated with a hydroxyapatite-collagen sponge (Bio-Oss Collagen® 250 mg, Geistlich) for closing alveolar defects during secondary dental eruption, further comparing these results to historical controls. Methods Six patients, aged 8 to 12, were selected. Autologous DDPSC were isolated from each patient, then associated with the biomaterial and this bone tissue engineered set was used to fill the alveolar defect. Computed tomography was performed to assess both preoperative and 6- and 12-month postoperative outcomes. Overall morbidity was recorded. Historical controls consisted of sixteen patients previously selected and randomly assigned to group one (rhBMP-2) or group two (iliac crest bone graft). Results DDPSC could be isolated and characterized as mesenchymal stem cells. Progressive alveolar bone union has occurred in all patients. Similarly to group two 75.4%, SD ± 4.0, p > 0.999, but statistically different from group one (59.6%, SD ± 9.9, p > 0.999, but statistically different from group one (59.6%, SD ± 9.9, Conclusion For this selected group of patients, DDPSC therapy resulted in satisfactory bone healing with excellent feasibility and safety, which adds significantly to the prospect of stem cell use in clinical settings. Clinical Question/Level of Evidence. Therapeutic, II. This trial is registered with https://clinicaltrials.gov/ct2/show/NCT01932164?term=NCT01932164&rank=1.
Highlights
The results of this prospective cohort of patients were compared to historical controls, which received either the traditional iliac crest bone graft or bone morphogenetic protein 2 [6]
deciduous dental pulp stem cells (DDPSC) were characterized by inducing cellular differentiation into bone, cartilage, and fat
We report for the first time the use of DDPSC for maxillary alveolar reconstruction in cleft lip and palate (CLP) patients
Summary
To overcome donor site morbidity during secondary maxillary alveolar reconstruction in cleft lip and palate (CLP) patients, many innovative efforts regarding various bone substitutes have been reported [1, 2].the lack of bioactivity, biomechanical weaknes, and susceptibility to infection are still detrimental to the use of most of them; [3] and even for bone morphogenetic proteins, recently suggested as an effective alternative [4,5,6,7], significant restraints concerning high costs and severe adverse events have emerged [8,9,10,11].Diversely, tissue engineering strategies arise as a new therapeutic option and one of the research hotspots in recent years [2, 12,13,14,15,16]. Considering that during the mixed dentition every child has deciduous exfoliating teeth, we decided to carry out a phase 1 clinical study using deciduous dental pulp stem cells (DDPSC) for maxillary alveolar cleft reconstruction (Figure 1) [17, 18]. The results of this prospective cohort of patients were compared to historical controls, which received either the traditional iliac crest bone graft or bone morphogenetic protein 2 (rhBMP-2) [6].
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