Table 5.
Ongoing and upcoming clinical trials involving limbal stem cells.
| Reference/ID Number | Procedure | Summary | Trial Phase |
|---|---|---|---|
| NCT03957954 | Cultivated LSC transplantation | Cultivated LSC transplantation in uniocular cases of severe-to-total LSCD secondary to injury or ocular surgery as compared to scleral CL control | Phase 1 (Ongoing) |
| NCT03884569 | Cultivated limbal epithelial transplantation | Cultivated limbal epithelial transplantation observational study | N/A (not yet recruiting) |
| NCT03549299 | Pharmacological intervention | Study of the efficacy of investigational medicinal product LSC2 topically administered on eye affected by LSCD. LSC2 contains ABCB5-positive LSCs from cadaveric donors. | Phase 1/2a (Active) |
| NCT02592330 | Cultivated autologous limbal epithelial cell transplantation | LSCs from unaffected eye are harvested, expanded and then subsequently transplanted into the affected eye. | Phase1/2 (Active) |
| NCT01756365 | Cultured corneal epithelium graft transplantation | Autologous corneal epithelium will be cultured to produce a graft of reconstructed corneal epithelium for transplantation. | Phase1/2 (Recruiting) |
| NCT04995926 | Labial mucosal epithelium grafting for corneal limbus substitution | Transplantation of autologous labial mucosal epithelium as a substitute for LSCs, as described by Liu et al., 2011 and Choe et al., 2019. | N/A (Enrolling) |
| NCT03288844 | Cultivated autologous LSC transplantation | Multinational follow-up study of the HOLOCORE trial. Determination of long-term safety and efficacy after autologous cultivated LSC transplantation | N/A (Recruiting) |
| NCT04021134 | Allogeneic simple limbal epithelial transplantation | Observational study investigating the effects of allogeneic simple limbal epithelial transplantation | N/A (Recruiting) |
| NCT04021875 | Autologous simple limbal epithelial transplantation | Observational study investigating the effects of autologous simple limbal epithelial transplantation | N/A (Recruiting) |
| NCT03943797 | Cultivated autologous oral mucosa epithelial sheet | Evaluation of the efficacy of a protocol using collagenase instead of trypsin/EDTA to isolate and cultivate oral mucosal epithelial cells | Phase 1 (Recruiting) |
| NCT03949881 | Cultivated autologous oral mucosa epithelial sheet | Evaluation of the efficacy and patient tolerance of cultivated autologous oral mucosa epithelial sheets in bilateral cases of total LSCD with the use of collagenase as opposed to trypsin/EDTA. | Phase 2 (Recruiting) |
| NCT04932629 | LSC application for treatment of superficial corneal pathologies | Transplantation of ex-vivo cultivated allogeneic limbal stromal cells for patients with unilateral superficial corneal scars | Phase 1 (Not yet recruiting) |
| NCT02886611 | Non-therapeutic investigation | Investigation of genotype–phenotype correlation in patients with genetic etiologies of LSCD | N/A (Recruiting) |
| Completed | |||
| NCT02577861 | Holoclar: cultivated autologous LSC transplantation | Validation of the efficacy of Holoclar for patients with moderate-to-severe LSCD secondary to ocular burn at 1 year post-procedure | Phase 4 (Completed) |
| NCT03226015 | Autologous oral mucosa transplantation | Clinical and histochemical results after oral mucosa graft transplantation in eyes with LSCD | N/A (Prospective, Completed) |
| NCT02649621 | Pharmacological investigation | Prospective clinical trial comparing the improvement of LSCD in vivo after use of Amniotic Membrane Extract Eye Drop (AMEED) | Phase 1 (Completed) |
| NCT00736307 | Cultivated autologous LSC transplantation | Evaluation of the efficacy, safety, and long-term outcomes of transplantation of ex vivo cultured LSCs on amniotic membrane for corneal surface reconstruction in cases of severe LSCD | Phase 2 (Completed) |
| NCT02415218 | Cultivated autologous oral mucosa epithelial sheet | Evaluation of the efficacy and safety of cultivated oral mucosal epithelial sheet transplantation for LSCD therapy | Phase 2 (Completed) |
| NCT03217435 | Epithelial allograft transplantation from living-related donor | Comparison of efficacy of femtosecond laser-assisted corneal epithelial allograft from living-related donor vs. limbal conjunctival allograft from living-related donor for ocular surface reconstruction in patients with LSCD | N/A (Completed) |
| NCT02568527 | Simple limbal epithelial transplantation | Pilot safety and efficacy study of a synthetic biodegradable membrane as a substitute for donor human amniotic membrane [122] for LSCD treatment in combination with limbal tissue freshly excised in theatre as a one-stage procedure | N/A (Completed) |
| NCT03594370 | Non-therapeutic investigation | Study of the ability of optical coherence tomography (OCT) analysis to predict the condition of limbal epithelial stem cells as a potential patient-friendly tool to detect limbal conditions | N/A (Completed) |
| NCT04773431 | Cultivated autologous limbal epithelial cell sheet transplantation | Evaluation of the tolerability and safety of LSCD101 (cultured autologous limbal epithelial cell sheet) transplantation in patients with intractable LSCD | Phase 1 (Completed) |
| NCT01619189 | Cultivated LSC transplantation | Prospective, non-comparative monocentric study of transplantation of allogeneic or autologous LSCs cultured on human amniotic membrane [122] with no feeder cells in eyes with total limbal deficiency | Phase 2 (Completed) |
| NCT04484402 | Autologous LSC transplantation | Treatment of inflammatory-dystrophic corneal diseases using autologous LSCs (corneal epithelial stem cells) or adipose-derived MSCs | Phase 2 (Completed) |
| NCT04552730 | Pharmacological investigation | Study of the efficacy and safety of nerve growth factor in the treatment of LSCD associated with neurotrophic cornea | N/A (Completed) |
| NCT00265590 | Non-therapeutic investigation | Study of specific gene changes in patients with aniridia, a disease in which the iris is fully or partially absent, focusing particularly on corneal changes | N/A (Completed) |
| NCT01237600 | Cultivated LSC transplantation | Study to elucidate the appropriate conditions for developing cultivated corneal epithelial grafts and to evaluate transplantation outcomes | Phase 3 (Completed) |