Autologous Cultured Fibroblast Injection for Facial Contour Deformities: A Prospective, Placebo-Controlled, Phase III Clinical Trial

BACKGROUND: Previous data indicate that injections of autologous fibroblasts increase collagen formation, accompanied by a concomitant increase in thickness and density of dermal collagen. OBJECTIVE: The purpose of this study was to determine efficacy and side effects of autologous living fibroblast injections versus placebo in a randomized Phase III trial for the treatment of various facial contour defects. METHODS: This was a double-blind, randomized comparison of injectable living autologous fibroblast cells and placebo for the treatment of facial contour defects (N=215). Live fibroblasts (20 million/mL) or placebo (the transport medium without living cells) were given as three doses administered at 1- to 2-week intervals. Efficacy evaluations were performed 1, 2, 4, 6, 9, and 12 months after the first injection. RESULTS: Living fibroblasts produced statistically significantly greater improvements in dermal deformities and acne scars than did placebo. The difference between live fibroblast injections and placebo achieved statistical significance at 6 months (p<.0001). At 9- and 12-month follow-up, live fibroblast-treated patients continued to demonstrate benefit from treatment with response rates of 75.0 and 81.6%, respectively. No serious treatment-related adverse events were reported. CONCLUSIONS: Our results indicate that autologous fibroblast injections can safely and effectively produce improvements in rhytids, acne scars, and other dermal defects continuing for at least 12 months after injection.     

Emergency orthodontic treatment after the traumatic intrusive luxation of maxillary incisors.

Treatment of traumatically intruded teeth is based largely on empirical clinical experience rather than on scientific data. The aim of this qualitative meta-analysis was to provide an evidence base to evaluate the orthodontic repositioning approach. In a MEDLINE search of the literature in English, 14 reported patients involving 22 teeth were found to have been treated by this modality. Additionally, 3 new patients, involving 9 intruded teeth and presented herein, were combined to form a total study sample of 17 subjects (7 girls, 10 boys, aged 8.9 +/- 1.2 years). Orthodontic extrusive forces were applied in the immediate posttrauma period (up to 3 months), with a variety of orthodontic appliances. Repositioning was achieved for 90.3% of the affected teeth but failed in 9.7% because of inflammatory resorption (2 teeth) or a misdiagnosis of root fracture (1 tooth). Early complications included loss of pulp vitality and external root resorption. All intruded teeth with closed root apices lost their vitality regardless of the degree of intrusion, whereas among those with incomplete apices, 45.5% that had been moderately intruded remained vital. External resorption was encountered in 54.8% of the teeth. Loss of marginal bone support was rarely encountered. Late complications included inflammatory root resorption in teeth with closed apices, in which endodontic treatment was not initially performed, and obliteration of the pulp tissue in teeth that remained vital. The results show that this method is superior to other treatment alternatives.