Clinical trial of autologous cultivated limbal epithelial cell sheet transplantation for patients with limbal stem cell deficiency
Objective or Purpose To confirm the efficacy and safety of Good Manufacturing Practice (GMP)-compliant autologous cultivated limbal epithelial cell sheets in government-controlled clinical trials that adhered to Good Clinical Practice stipulations for patients with unilateral limbal stem cell defici...
Published in: | Ophthalmology |
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Elsevier
2023
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Online Access: | https://orca.cardiff.ac.uk/id/eprint/156536/ https://doi.org/10.1016/j.ophtha.2023.01.016 https://orca.cardiff.ac.uk/id/eprint/156536/1/1-s2.0-S0161642023000611-main.pdf |
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ftunivcardiff:oai:https://orca.cardiff.ac.uk:156536 2023-12-17T10:49:42+01:00 Clinical trial of autologous cultivated limbal epithelial cell sheet transplantation for patients with limbal stem cell deficiency Oie, Yoshinori Sugita, Seiichiro Yokokura, Shunji Nakazawa, Toru Tomida, Daisuke Satake, Yoshiyuki Shimazaki, Jun Hara, Yuko Shiraishi, Atsushi Quantock, Andrew J. Ogasawara, Takahiro Inoie, Masukazu Nishida, Kohji 2023-06-30 application/pdf https://orca.cardiff.ac.uk/id/eprint/156536/ https://doi.org/10.1016/j.ophtha.2023.01.016 https://orca.cardiff.ac.uk/id/eprint/156536/1/1-s2.0-S0161642023000611-main.pdf en eng Elsevier https://orca.cardiff.ac.uk/id/eprint/156536/1/1-s2.0-S0161642023000611-main.pdf Oie, Yoshinori, Sugita, Seiichiro, Yokokura, Shunji, Nakazawa, Toru, Tomida, Daisuke, Satake, Yoshiyuki, Shimazaki, Jun, Hara, Yuko, Shiraishi, Atsushi, Quantock, Andrew J. https://orca.cardiff.ac.uk/view/cardiffauthors/A0636159.html orcid:0000-0002-2484-3120 orcid:0000-0002-2484-3120, Ogasawara, Takahiro, Inoie, Masukazu and Nishida, Kohji 2023. Clinical trial of autologous cultivated limbal epithelial cell sheet transplantation for patients with limbal stem cell deficiency. Ophthalmology 130 (6) , pp. 608-614. 10.1016/j.ophtha.2023.01.016 https://doi.org/10.1016/j.ophtha.2023.01.016 Item availability restricted. file <https://orca.cardiff.ac.uk/id/eprint/156536/1/1-s2.0-S0161642023000611-main.pdf> doi:10.1016/j.ophtha.2023.01.016 cc_by_nc_nd_4_0 Article PeerReviewed 2023 ftunivcardiff https://doi.org/10.1016/j.ophtha.2023.01.016 2023-11-23T23:34:55Z Objective or Purpose To confirm the efficacy and safety of Good Manufacturing Practice (GMP)-compliant autologous cultivated limbal epithelial cell sheets in government-controlled clinical trials that adhered to Good Clinical Practice stipulations for patients with unilateral limbal stem cell deficiency (LSCD). Design A prospective, multi-center, open-label, uncontrolled, single-arm clinical trial. Subjects, Participants or Controls Ten consecutive eyes of 10 patients with unilateral LSCD were followed for two years after surgery. Preoperative LSCD stage was IIB in four eyes and III in six eyes. Methods A limbal tissue biopsy was obtained from the healthy eye, after which limbal stem cells were dissociated and cultivated on temperature-responsive culture surfaces. All cell sheets were fabricated in a GMP-grade facility under established standard operating procedures. Cell sheets were evaluated using defined shipment criteria before transplantation, and only those that met the criteria were used. The cell sheet was transplanted onto each of the patients' diseased eye after removing the conjunctival scar tissue that covered the corneal surface. The severity of LSCD was determined according to a staging method agreed upon by global consensus, with eyes evaluated as being in stages IA–C representing successful corneal epithelial reconstruction. LSCD diagnosis and staging were determined by the trial's Eligibility Judgment Committee and Effect Assessment Committee using slit-lamp photographs including fluorescein staining. Both committees comprised two or three third-party cornea specialists, who were provided with information anonymously and randomly. Main Outcome Measure Corneal epithelial reconstruction rate was the primary endpoint. Results Corneal epithelial reconstruction was successful in six of 10 eyes (60%) one year postoperatively and was significantly higher than the 15% clinically significant efficacy rate achieved by allogeneic limbal transplantation. The reconstruction rate was 70% of eyes two years ... Article in Journal/Newspaper SCAR Cardiff University: ORCA (Online Research @ Cardiff) Ophthalmology |
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Cardiff University: ORCA (Online Research @ Cardiff) |
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ftunivcardiff |
language |
English |
description |
Objective or Purpose To confirm the efficacy and safety of Good Manufacturing Practice (GMP)-compliant autologous cultivated limbal epithelial cell sheets in government-controlled clinical trials that adhered to Good Clinical Practice stipulations for patients with unilateral limbal stem cell deficiency (LSCD). Design A prospective, multi-center, open-label, uncontrolled, single-arm clinical trial. Subjects, Participants or Controls Ten consecutive eyes of 10 patients with unilateral LSCD were followed for two years after surgery. Preoperative LSCD stage was IIB in four eyes and III in six eyes. Methods A limbal tissue biopsy was obtained from the healthy eye, after which limbal stem cells were dissociated and cultivated on temperature-responsive culture surfaces. All cell sheets were fabricated in a GMP-grade facility under established standard operating procedures. Cell sheets were evaluated using defined shipment criteria before transplantation, and only those that met the criteria were used. The cell sheet was transplanted onto each of the patients' diseased eye after removing the conjunctival scar tissue that covered the corneal surface. The severity of LSCD was determined according to a staging method agreed upon by global consensus, with eyes evaluated as being in stages IA–C representing successful corneal epithelial reconstruction. LSCD diagnosis and staging were determined by the trial's Eligibility Judgment Committee and Effect Assessment Committee using slit-lamp photographs including fluorescein staining. Both committees comprised two or three third-party cornea specialists, who were provided with information anonymously and randomly. Main Outcome Measure Corneal epithelial reconstruction rate was the primary endpoint. Results Corneal epithelial reconstruction was successful in six of 10 eyes (60%) one year postoperatively and was significantly higher than the 15% clinically significant efficacy rate achieved by allogeneic limbal transplantation. The reconstruction rate was 70% of eyes two years ... |
format |
Article in Journal/Newspaper |
author |
Oie, Yoshinori Sugita, Seiichiro Yokokura, Shunji Nakazawa, Toru Tomida, Daisuke Satake, Yoshiyuki Shimazaki, Jun Hara, Yuko Shiraishi, Atsushi Quantock, Andrew J. Ogasawara, Takahiro Inoie, Masukazu Nishida, Kohji |
spellingShingle |
Oie, Yoshinori Sugita, Seiichiro Yokokura, Shunji Nakazawa, Toru Tomida, Daisuke Satake, Yoshiyuki Shimazaki, Jun Hara, Yuko Shiraishi, Atsushi Quantock, Andrew J. Ogasawara, Takahiro Inoie, Masukazu Nishida, Kohji Clinical trial of autologous cultivated limbal epithelial cell sheet transplantation for patients with limbal stem cell deficiency |
author_facet |
Oie, Yoshinori Sugita, Seiichiro Yokokura, Shunji Nakazawa, Toru Tomida, Daisuke Satake, Yoshiyuki Shimazaki, Jun Hara, Yuko Shiraishi, Atsushi Quantock, Andrew J. Ogasawara, Takahiro Inoie, Masukazu Nishida, Kohji |
author_sort |
Oie, Yoshinori |
title |
Clinical trial of autologous cultivated limbal epithelial cell sheet transplantation for patients with limbal stem cell deficiency |
title_short |
Clinical trial of autologous cultivated limbal epithelial cell sheet transplantation for patients with limbal stem cell deficiency |
title_full |
Clinical trial of autologous cultivated limbal epithelial cell sheet transplantation for patients with limbal stem cell deficiency |
title_fullStr |
Clinical trial of autologous cultivated limbal epithelial cell sheet transplantation for patients with limbal stem cell deficiency |
title_full_unstemmed |
Clinical trial of autologous cultivated limbal epithelial cell sheet transplantation for patients with limbal stem cell deficiency |
title_sort |
clinical trial of autologous cultivated limbal epithelial cell sheet transplantation for patients with limbal stem cell deficiency |
publisher |
Elsevier |
publishDate |
2023 |
url |
https://orca.cardiff.ac.uk/id/eprint/156536/ https://doi.org/10.1016/j.ophtha.2023.01.016 https://orca.cardiff.ac.uk/id/eprint/156536/1/1-s2.0-S0161642023000611-main.pdf |
genre |
SCAR |
genre_facet |
SCAR |
op_relation |
https://orca.cardiff.ac.uk/id/eprint/156536/1/1-s2.0-S0161642023000611-main.pdf Oie, Yoshinori, Sugita, Seiichiro, Yokokura, Shunji, Nakazawa, Toru, Tomida, Daisuke, Satake, Yoshiyuki, Shimazaki, Jun, Hara, Yuko, Shiraishi, Atsushi, Quantock, Andrew J. https://orca.cardiff.ac.uk/view/cardiffauthors/A0636159.html orcid:0000-0002-2484-3120 orcid:0000-0002-2484-3120, Ogasawara, Takahiro, Inoie, Masukazu and Nishida, Kohji 2023. Clinical trial of autologous cultivated limbal epithelial cell sheet transplantation for patients with limbal stem cell deficiency. Ophthalmology 130 (6) , pp. 608-614. 10.1016/j.ophtha.2023.01.016 https://doi.org/10.1016/j.ophtha.2023.01.016 Item availability restricted. file <https://orca.cardiff.ac.uk/id/eprint/156536/1/1-s2.0-S0161642023000611-main.pdf> doi:10.1016/j.ophtha.2023.01.016 |
op_rights |
cc_by_nc_nd_4_0 |
op_doi |
https://doi.org/10.1016/j.ophtha.2023.01.016 |
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Ophthalmology |
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1785574247214612480 |