Comparative evaluation of autologous tissue-engineered ocular and oral mucosal tissue grafts- a prospective randomized controlled trial

• Published in: BMC biotechnology 2024-10, Vol.24 (1), p.82-12, Article 82
• Main Authors: Tandon, Radhika, Pandey, Pranav Kumar, Khan, Tanveer Alam, Das, Amit Kumar, Kalaivani, Mani, Majood, Misba, Kashyap, Seema, Sen, Seema, Lomi, Neiwete, Gupta, Noopur, Vanathi, M, Mohanty, Sujata
• Format: Article
• Language: English
• Subjects: Acuity; Adolescent; Adult; Amniotic membrane; Antibiotics; Autografts; Care and treatment; Chemical injury; Conjunctiva - transplantation; Conjunctival epithelial cells; Cornea; Corneal diseases; Cultivated oral mucosal epithelial transplantation (COMET); Disease control; Effectiveness; Epithelial cells; Epithelial Cells - transplantation; Epithelium; Ethical standards; Eye; Eye (anatomy); Eye diseases; Female; Health aspects; Humans; Injuries; International standards; Iodine; Male; Methods; Middle Aged; Mouth Mucosa - transplantation; Mucosa; Mucous membrane; Ocular surface disease (OSD); Oral mucosal epithelial cells; Parameters; Patients; Penicillin; Prospective Studies; Statistical analysis; Stem cell transplantation; Stevens-Johnson syndrome; Stevens-Johnson Syndrome - surgery; Success; Surface stability; Surgery; Testing; Tissue engineering; Tissue Engineering - methods; Tissue engineering, ex vivo expansion; Transplantation; Transplantation of organs, tissues, etc; Transplantation, Autologous; Treatment Outcome; Vascularization; Visual acuity; Young Adult
• ISSN: 1472-6750; 1472-6750
• DOI: 10.1186/s12896-024-00876-z

Bilateral ocular surface disease resulting from Stevens Johnson Syndrome (SJS) and chemical injuries are visually debilitating and difficult to treat. Ocular surface reconstruction by various means has been reported with variable results. This study addresses an unmet need for a prospective clinical trial comparing the outcomes of transplanting autologous oral and conjunctival epithelial cell constructs on human amniotic membrane by ex vivo tissue engineering. A prospective, randomized controlled clinical trial was prospectively applied for registration, with the clinical trial registry of India (CTRI), with the approval of the Institute Ethics Committee number IEC/NP-99/11.04.2014 and CTRI No. REF/2018/10/021791, the study also registered with the WHO-recognized trial registry, International Standard Randomised Controlled Trial Number (ISRCTN) registration reference number 45780. The study was conducted to compare clinical outcomes of two different tissue-engineered cell grafts, Cultivated Oral Mucosal Epithelial Transplantation (COMET) and Conjunctival Cultivated Epithelial Transplantation (CCET) for ocular surface reconstruction in patients with bilateral ocular surface disease due to Stevens-Johnson Syndrome or chemical injuries. Fifty patients were enrolled and randomized to either the COMET or CCET group. A uniform pre-op and post-op protocol using standard medications was followed for all patients Parameters assessed at baseline, day 1, 1 week, 2 weeks, 1 month, 2 months, 3 months and 6 months postoperatively included patient comfort, best corrected visual acuity (BCVA), ocular surface status and corneal clarity. The efficacy was measured in terms of improvement of vision, reduction in vascularization, symblepharon and corneal clarity. In the study, 50 patients (50 eyes; mean ages of 29 ± 15.86 years and 26.36 ± 10.85 years, respectively; range, 12-65 years) were enrolled, with 25 patients each in the COMET and CCET groups. Out of them, 36% were female and 64% were male; the causes were Steven Johnson syndrome (48), and chemical injury (2). Mean pre-operative BCVA was log MAR 1.73 ± 0.57 for COMET and 1.99 ± 0.33 for the CCET group. Pre-operatively all 50 enrolled patients had opaque corneas pre-operatively, symblepharon that extended to the cornea categorised as grade 3 and corneal vascularization that went beyond the pupil's boundary into the central zone encluaching on the visual axis. The minimal follow-up time was six months. Following surgery