Clinical study of injectable collagen scaffold with autologous fat cells for repair of severe vocal fold injury.

Cell retention and survival after transplantation remains a major problem for long-term efficiency in therapy of severe vocal fold injury with autologous cells. In this study, injectable collagen scaffold was used to deliver autologous fat cells (AFCs) for repairing of severe vocal fold injury. We found injectable collagen scaffold could enhance the retention and survival of green fluorescent protein (GFP) labeled fat cells in the transplantation sites in rats. Based on these data, a randomized controlled clinical trial was conducted to evaluate the safety and efficiency of transplantation of collagen scaffold with AFCs for severe vocal fold injury. Ten patients with vocal fold paralysis were randomly assigned to control (AFCs only) and intervention (AFCs + collagen) groups. AFCs with or without collagen scaffold were injected into vocal folds of patients under general anesthesia, respectively. The safety and efficacy were regularly assessed during 24 months post-surgery. No obvious complications occurred in all patients during the follow-up. The collagen scaffold maintained the stability of implants after injection and reconstructed the vocal fold structure. The improvement of voice quality of patients was observed through voice quality evaluation with the voice handicap index (VHI) questionnaire, as well as acoustic analysis of maximum phonation time, jitter, and shimmer. The VHI score of patients in AFCs + collagen group improved significantly than those in AFCs group at 6, 12 and 24 months post-surgery. It demonstrates the injectable collagen scaffold is safe and efficient for delivering AFCs for vocal fold injury.