Abstract
Purpose :
Human limbus-derived mesenchymal stem cells (hLMSC) have the potential to promote scarless corneal wound healing. Alginate encapsulation can be used as a method of preservation and transportation of hLMSC for clinical transplantation. This study evaluated the safety and efficacy of hLMCS for the treatment of superficial corneal pathologies.
Methods :
This was an open-labeled single-arm phase 0/1 clinical trial. The study was approved by the institutional review board, the institutional committee for stem cell research, and the Indian regulatory agencies. The inclusion criteria were adult patients with unilateral superficial corneal pathologies involving 1/3 to 1/4 of the corneal thickness, including post-infectious corneal scars, sterile ulcers, and burns. Exclusion criteria included post-viral infectious scars. Clinical transplantation-grade human limbal tissue was sourced from an accredited eye bank. The limbal tissue was digested and cultured using a standardized protocol in an approved good manufacturing practice grade facility. Passage 3 hLMSC, meeting all the quality criteria were alginate encapsulated and stored. The cells were then released from the alginate and used for clinical transplantation. The surgical procedure involved debridement of the corneal epithelium followed by topical application of the cells mixed with commercially available fibrin glue. The primary outcome measure was safety, and the secondary outcome measure was efficacy defined as improvement in best corrected visual acuity, reflectivity on optical coherence tomography, and light scattering on Scheimpflug imaging.
Results :
This study included 20 patients who underwent the procedure. No serious adverse events were noted in any patient. In 17 eyes the epithelization of the treated area was completed in 7 days, while in the remaining 3 eyes it took 10 days. None of the treated eyes developed any signs of ocular inflammation. The BCVA showed significant improvement over time. There was a reduction in reflectivity on OCT imaging and a reduction in the densitometry readings on Scheimpflug imaging.
Conclusions :
The findings suggest that alginate-preserved hLMSC are safe and effective in the treatment of superficial corneal pathologies. The efficacy needs to be further validated in a multicentric randomized controlled trial.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.