A Comprehensive Review of Clinical Studies on Bacterial Cellulose: From the Earliest Uses to Contemporary Innovations.

Abstract

Bacterial cellulose (BC), a biopolymer produced by Gram-negative bacteria such as those from the Komagataeibacter genus, has emerged as a promising material in biomedical applications due to its exceptional purity, biocompatibility, mechanical strength, versatility in sterilization, biodegradability, and sustainable production. This comprehensive review traces the evolution of BC-based medical products from their initial development in the 1980s to present-day innovations, highlighting the progression of clinical evidence supporting their use. Early clinical studies primarily focused on BC as a temporary skin substitute for burns and ulcers. Over time, the scope of BC applications expanded to include dural defect repair, tympanic membrane reconstruction, and fetal surgery for spina bifida. The quality of clinical evidence has improved, with recent years seeing an increase in randomized controlled trials and larger patient cohorts. Several BC-based products are already commercially available, supported by regulatory approvals and a growing body of clinical data. This review seeks to serve as a valuable resource by providing an exhaustive recapitulation of published clinical studies on BC-based medical devices encompassing 3,857 subjects and offering insights into their efficacy, safety, and regulatory considerations. The review outlines future research directions to validate BC's potential across a wide range of in vivo biomedical applications.