Advances in Regulatory Strategies of Differentiating Stem Cells towards Keratocytes

Table 1

Clinical trials of stem cells used for corneal regeneration.

ID	Title	Phase	Patients ()	Stem cells	Outcome
NCT02932852	Autologous Adipose-Derived Adult Stem Cell Transplantation for Corneal Diseases	Early phase 1	12	hASCs	Vision recovery; topography; anterior segment optical coherence tomography; slit lamp observation; refraction measurement
NCT03878628	Treatment with Allogeneic Adipose-derived Mesenchymal Stem Cells in Patients with Aqueous Deficient Dry Eye Disease (MESADDE)	Early phase 1	7	hASCs	Injection site: pain, infection, bleeding; eyelid function disorder; periorbital edema; ocular discomfort; flu-like symptoms; fever; Ocular Surface Disease Index questionnaire; Schirmer’s test; tear osmolarity; Ocular SICCA Grading Score; HLA antibodies
NCT04932629	To Evaluate the Clinical Safety and Efficacy of Limbal Stem Cell for Treatment of Superficial Corneal Pathologies	Early phase 1	20	hCSSCs	Measurement of any ocular or systemic adverse effects; measurement of visual improvement; change in corneal light scattering
NCT01377311	The Improvement of Limbal Epithelial Culture Technique by Using Collagenase to Isolate Limbal Stem Cells	Phase 1	10	hCSSCs	Using collagenase to isolate limbal stem cells and improve the technique of ex vivo expansion of limbal stem cells for the treatment
NCT03295292	Limbus-derived Stem Cells for Prevention of Postoperative Corneal Haze	Phase 1	15	hCSSCs	Maintenance of preoperative best spectacle-corrected visual acuity; efficacy in reducing corneal light scatter using Scheimpflug imaging
NCT02948023	Stem Cells Therapy for Corneal Blindness (ExCell)	Phase 1	100	hCSSCs	Ocular or systemic adverse effects; visual improvement after treatment
NCT04484402	Treatment of Patients with Inflammatory-dystrophicDiseases of the Cornea Using Autologous Stem Cells	Phase 1; Phase 2	25	hASCs/hCSSCs	Number of cured patients, patients with treatment-related adverse events
NCT01562002	Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome	Phase 1; Phase 2	27	hBMSCs/hCSSCs	Viability and safety of mesenchymal stem cell transplant; absence of complications in pre- and perisurgical implantation; improvement of 2 lines in best-corrected visual acuity
NCT02148016	Corneal Epithelium Repair and Therapy Using Autologous Limbal Stem Cell Transplantation	Phase 1; Phase 2	30	hCSSCs	Composite measure of visual function in eyes treated for corneal ocular surface disease; composite measure of visual function in eyes after photorefractive keratectomy; incidence of transparency of the cornea; postoperative complications
NCT02592330	Limbal Stem Cell Deficiency (LSCD) Treatment with Cultivated Stem Cell (CALEC) Graft (CALEC)	Phase 1; Phase 2	17	hCSSCs	The occurrence of ocular infection, corneal perforation, graft %, and adverse events and their relationship to the study intervention; obtaining cell growth and maintaining cell viability; avoiding culture contamination; improvement in corneal surface integrity; decrease in neovascularization; decrease in subject symptoms
NCT02318485	Limbal Epithelial Stem Cell Transplantation: A Phase II Multicenter Trial (MLEC)	Phase 2	60	hCSSCs	Visual acuity; presence of persistent epithelial defects; presence of corneal conjunctivalization; change in corneal vascularization; pain; photophobia; rejection
NCT04615455	Mesenchymal Stem Cell Therapy of Dry Eye Disease in Patients with Sjögren’s Syndrome (AMASS)	Phase 2	40	hASCs	OSDI; noninvasive keratography tear break-up time (NIKBUT); tear meniscus height (TMH); Schirmer’s test; tear osmolarity; Oxford scale; HLA antibodies

Source of data: all comes from https://clinicaltrials.gov.