Table 2.
Clinical trials with corneal scarring treated by cell-based and cell-free approaches.
| ClinicalTrial.gov ID Year Initiated |
Title | Target Disease, Treatment | Sponsor | Status | Publications |
|---|---|---|---|---|---|
|
NCT01562002 2012 |
Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome Phase I/II, double masked |
LSCD | Institute of Applied Ophthalmobio-logy, Spain | Completed recruitment; N = 17 patients; No adverse effects. Improved CEpi healing |
[193] |
| Allogenic bone marrow MSCs Stem cells with amniotic membrane transplant | |||||
|
NCT02291770 2015 |
Mesenchymal stromal cells treatment attenuates dry eye in patients with chronic graft-versus-host disease | GVHD-DED | Guangdong Provincial People’s Hospital, China | No adverse effects. In total, 12 out of 22 patients had improved dry eye score, ocular surface disease index scores, and Schirmer test results |
[194,195] |
| Allogenic bone marrow MSCs Intravenous injection | |||||
| Phase III, multi-center, randomized, Open-label |
|||||
|
NCT02592330 2015 |
Limbal Stem Cell Deficiency (LSCD) Treatment With Cultivated Stem Cell (CALEC) Graft | LSCD | Massachusetts Eye and Ear Infirmary, USA | Completed recruitment | |
| Cultivated autologous limbal epithelial cell graft | |||||
| Phase I/II, open-label | CALEC Transplant | ||||
|
NCT03687632 2018 |
ST266 Eye Drops for the Treatment of Persistent Corneal Epithelial Defects Phase II, multi-center, open-label |
PED | Noveome Biotherapeutics | No adverse effects. A total of 10 out of 12 eyes had reduced PED area |
[196] |
| Multi-cytokine biologic solution from Amnion-derived Multipotent Progenitor culture Eye drops | |||||
|
NCT03878628 2019 |
Treatment With Allogeneic Adipose-derived MSC in Patients With Aqueous Deficient Dry Eye Disease (MESADDE) | DED Kerato-Conjunctivitis Sicca Aqueous Tear Deficiency |
Rigshospitalet, Denmark | No adverse effects. Decreased mean OSDI score, tear osmolarity; increased TBUT, Schirmer’s I test |
[197] |
| Allogeneic adipose-derived MSC | |||||
| Early Phase I, open-label | Transconjunctival injection | ||||
|
NCT04213248 2019 |
Effect of UMSCs Derived Exosomes on Dry Eye in Patients With cGVHD Phase I/II, open-label |
Dry Eye | Zhongshan Ophthalmic Center, Sun Yat-sen University, China | Recruiting No adverse effects; reduced fluorescein scores, longer tear-film breakup time; increased tear secretion; and lower OSDI scores |
[198] |
| Umbilical MSC-derived exosomes Eye drops | |||||
|
NCT04932629 2021 |
To Evaluate the Clinical Safety and Efficacy of Limbal Stem Cell for Treatment of Superficial Corneal Pathologies | Corneal scar and opacities | L.V. Prasad Eye Institute, India | ||
| Ex vivo cultivated allogeneic limbal stromal stem cells | |||||
| Early phase I open-label | Topical with fibrin glue | ||||
|
NCT05279157 2022 |
Autologous Adipose-Derived Adult Stem Cell Implantation for Corneal Diseases (ADASCs-CT-CD) Phase II |
Corneal dystrophy, keratoconus | Vissum, Instituto Oftalmológico de Alicante, Spain | Completed No adverse effects; improved stromal cell density, modulated scarring, visual improvement (~2 lines gain) |
[81,90,199] |
| Autologous adipose MSCs Corneal implantation | |||||
|
NCT06257355 2024 |
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars | Corneal scar | Claris Biotherapeutics, Inc. | Recruiting | |
| Human recombinant dHGF (hepatocyte growth factor) Eye drops | |||||
| Phase I Open-label |
Note: LSCD—limbal stem cell deficiency; GVHD-DED—graft-versus-host disease–dry eye disorders; MSC—mesenchymal stem cells; TBUT—tear breakup time; OSDI—ocular surface disease index; PED—persistent epithelial defect.