Table 2.
Results of clinical studies of UCBS therapy in ocular diseases
| Study (year) | Design | Condition | Population (n) | Control arm | Frequency (duration) | Concomitant therapy | Results |
|---|---|---|---|---|---|---|---|
| Vajpayee (2003) [39] | Prospective randomized double-blind | PED | Human (59) | Autologous serum | 6/day (21 days) | – | Higher percentage of reepithelization in UCBS group |
| Yoon (2005) [29] | Prospective interventional | PED | Human (14) | – | 6/day (until healing) | – | Faster epitheliopathy healing rate |
| Yoon (2007) [27] | Prospective interventional | NK | Human (28) | – | 6–10/day (until healing) | Tear substitutes, levofloxacin | 100% healing within 4.4 weeks on average |
| Yoon (2007) [28] | Prospective interventional comparative | Dry eye | Human (48) | Autologous serum | 6–10/day (2 months) | Tear substitutes | Major improvements in symptoms, keratoepitheliopathy score, and goblet cell density in hUCBS-treated group |
| Yoon (2007) [30] | Prospective interventional noncomparative | GVHD | Human (12) | – | 6–10/day (6 months) | Tear substitutes | Significant improvements in symptoms, corneal sensitivity, TBUT, and keratoepitheliopathy scores |
| Sharma (2011) [40] | Prospective randomized double-blind | Chemical injury | Human (32) | Autologous serum/tear substitutes | 10/day (3 months) | Ofloxacin, prednisolone acetate, homatropine hydrobromide, sodium citrate, ascorbate, tear substitutes | Higher percentage of corneal transparency in UCBS group |
| Oh (2012) [35] | Prospective interventional comparative randomized | Chemical injury | Mice (24) | hPBS, tear substitutes | 4/day (–) | Levofloxacin | Lower ED parameters, haze scores, stromal inflammation, edema, and IL-1β levels in hUCBS group |
| Yoon (2013) [32] | Prospective interventional comparative | Post-LASEK PED | Human (60) | Conventional therapy (antibiotics, steroid, and artificial tear eyedrops) | 4–6/day (–) | Conventional therapy (antibiotics, steroid, and artificial tear eyedrops) | Longer TBUT and lower keratoepitheliopathy and TGF-β1 levels in hUCBS-treated group |
| Versura (2013) [42] | Prospective interventional | PED | Human (30) | – | 8/day (1 month) | – | Significant reduction in epithelial damage |
| Erdem (2014) [41] | Prospective interventional | PED | Human (14) | – | 5–10/day (21 days) | Tear substitutes, lomefloxacin | 75% healing within 12 days |
| Mukhopadhyay (2015) [7] | Prospective interventional comparative randomized | Dry eye | Human (144) | Autologous serum, tear substitutes | 6/day (6 weeks) | – | Significant improvements in clinical parameters and tear protein profile (lysozyme and lactoferrin upregulation, sustained increase in total tear protein level) in serum-treated groups |
| Giannaccare (2017) [6] | Prospective interventional open-label | cGVHD, Sjögren syndrome, diabetic keratopathy, neurotrophic keratitis | Human (20) | – | 8/day (2 months) | – | Significant decreases in OSDI, VAS, and Oxford grading values. Significant increases in corneal sensitivity, ST, and BUT scores. Higher total number of nerves as well as improved morphology and lower tortuosity. Presence of neuromas and higher dendritic cell density at baseline associated with greater reduction in OSDI after treatment |
| Kamble (2017) [43] | Prospective interventional comparative randomized | Post-keratoplasty PED | Human (105) | Autologous serum, tear substitutes | 6/day (until healing) | – | Decreased ED size and faster reepithelialization in serum-treated groups |
| Han (2019) [34] | Prospective interventional comparative randomized | Chemical injury | Mice (28) | hAM; hPBS; saline | 4/day (7 days) | – | Major decrease in epithelial defect areas in hUCBS group compared with hAM, hPBS, and saline groups. Reductions in degree of corneal opacity and inflammatory marker expression (TNF-α, IL-6, MMP-8, and MMP-9 mRNA) in all treatment groups |
| Campos (2019) [44] | Multicenter, randomized, double-masked crossover clinical trial | Severe dry eye disease | Human (60) | Peripheral adult donor blood serum eye drops | 8/day (1 month) | – | Corneal staining was more significantly reduced after the CBS treatment. Reduced VAS and OSDI scores were observed in both groups |
UCBS umbilical cord blood serum, NK neurotrophic keratitis, PED persistent epithelial defect, RCE recurrent corneal erosion, hAM human amniotic membrane, hPBS human peripheral blood serum, cGVHD chronic graft-versus-host disease, OSDI Ocular Surface Disease Index, VAS Visual Analogue Scale, ST Schirmer’s test, TBUT tear break-up time, ED epithelial defect, LASEK laser epithelial keratomileusis