Allogeneic mesenchymal stem cell therapy for dry eye disease in patients with Sjögren's syndrome: A randomized clinical trial

Research output: Contribution to journal › Journal article › Research › peer-review

Standard

Allogeneic mesenchymal stem cell therapy for dry eye disease in patients with Sjögren's syndrome : A randomized clinical trial. / Møller-Hansen, Michael; Larsen, Ann Cathrine; Wiencke, Anne K.; Terslev, Lene; Siersma, Volkert; Andersen, Tobias T.; Hansen, Adam E.; Bruunsgaard, Helle; Haack-Sørensen, Mandana; Ekblond, Annette; Kastrup, Jens; Utheim, Tor P.; Heegaard, Steffen.

In: Ocular Surface, Vol. 31, 2024, p. 1-8.

Research output: Contribution to journal › Journal article › Research › peer-review

Harvard

Møller-Hansen, M, Larsen, AC, Wiencke, AK, Terslev, L, Siersma, V, Andersen, TT, Hansen, AE, Bruunsgaard, H, Haack-Sørensen, M, Ekblond, A, Kastrup, J, Utheim, TP & Heegaard, S 2024, 'Allogeneic mesenchymal stem cell therapy for dry eye disease in patients with Sjögren's syndrome: A randomized clinical trial', Ocular Surface, vol. 31, pp. 1-8. https://doi.org/10.1016/j.jtos.2023.11.007

APA

Møller-Hansen, M., Larsen, A. C., Wiencke, A. K., Terslev, L., Siersma, V., Andersen, T. T., Hansen, A. E., Bruunsgaard, H., Haack-Sørensen, M., Ekblond, A., Kastrup, J., Utheim, T. P., & Heegaard, S. (2024). Allogeneic mesenchymal stem cell therapy for dry eye disease in patients with Sjögren's syndrome: A randomized clinical trial. Ocular Surface, 31, 1-8. https://doi.org/10.1016/j.jtos.2023.11.007

Vancouver

Møller-Hansen M, Larsen AC, Wiencke AK, Terslev L, Siersma V, Andersen TT et al. Allogeneic mesenchymal stem cell therapy for dry eye disease in patients with Sjögren's syndrome: A randomized clinical trial. Ocular Surface. 2024;31:1-8. https://doi.org/10.1016/j.jtos.2023.11.007

Author

Møller-Hansen, Michael ; Larsen, Ann Cathrine ; Wiencke, Anne K. ; Terslev, Lene ; Siersma, Volkert ; Andersen, Tobias T. ; Hansen, Adam E. ; Bruunsgaard, Helle ; Haack-Sørensen, Mandana ; Ekblond, Annette ; Kastrup, Jens ; Utheim, Tor P. ; Heegaard, Steffen. / Allogeneic mesenchymal stem cell therapy for dry eye disease in patients with Sjögren's syndrome : A randomized clinical trial. In: Ocular Surface. 2024 ; Vol. 31. pp. 1-8.

Bibtex

@article{9e485b1e9c954d4ab9bfa3965e979979,
title = "Allogeneic mesenchymal stem cell therapy for dry eye disease in patients with Sj{\"o}gren's syndrome: A randomized clinical trial",
abstract = "Purpose: This double-blinded randomized clinical trial aimed to evaluate the efficacy of injecting allogeneic adipose-derived mesenchymal stem cells (ASCs) into the lacrimal gland (LG) for the treatment of dry eye disease (DED) secondary to Sj{\"o}gren's syndrome (SS). Methods: Fifty-four participants with severe DED secondary to SS were included and allocated to either ASCs (n = 20), vehicle (n = 20), or a non-randomized observation group (n = 14). The intervention groups received a single injection of either ASCs or an active comparator (vehicle, Cryostor{\textregistered} CS10) into the LG in one eye, while the observation group received lubricating eye drops only. The primary outcome measure was changes in Ocular Surface Disease Index (OSDI) score and secondary outcome measures were non-invasive tear break-up time, tear meniscus height, Schirmer's test, and Oxford score within a 12-month follow-up. Results: A significant reduction in OSDI score was observed in the ASCs and vehicle groups compared to the observation group. In addition, the ASCs group demonstrated a significant increase in non-invasive tear break-up time compared to the vehicle group at the 4-week follow-up and to the observation group at the 12-month follow-up. A significant improvement in ocular surface staining, tear osmolarity, and Schirmer test score from baseline was also observed in the ASCs group; however, these changes were not significant compared to the other groups. Conclusion: Improvement of subjective and objective signs and symptoms of DED was observed in both intervention groups following injection into the LG compared to the observation group. Future studies should investigate the mode-of-action of both injection treatments.",
keywords = "Dry eye disease, Lacrimal gland, Mesenchymal stem cells, Regenerative medicine, Stem cell therapy",
author = "Michael M{\o}ller-Hansen and Larsen, {Ann Cathrine} and Wiencke, {Anne K.} and Lene Terslev and Volkert Siersma and Andersen, {Tobias T.} and Hansen, {Adam E.} and Helle Bruunsgaard and Mandana Haack-S{\o}rensen and Annette Ekblond and Jens Kastrup and Utheim, {Tor P.} and Steffen Heegaard",
note = "Publisher Copyright: {\textcopyright} 2023",
year = "2024",
doi = "10.1016/j.jtos.2023.11.007",
language = "English",
volume = "31",
pages = "1--8",
journal = "The Ocular Surface",
issn = "1542-0124",
publisher = "Elsevier",

}

RIS

TY - JOUR

T1 - Allogeneic mesenchymal stem cell therapy for dry eye disease in patients with Sjögren's syndrome

T2 - A randomized clinical trial

AU - Møller-Hansen, Michael

AU - Larsen, Ann Cathrine

AU - Wiencke, Anne K.

AU - Terslev, Lene

AU - Siersma, Volkert

AU - Andersen, Tobias T.

AU - Hansen, Adam E.

AU - Bruunsgaard, Helle

AU - Haack-Sørensen, Mandana

AU - Ekblond, Annette

AU - Kastrup, Jens

AU - Utheim, Tor P.

AU - Heegaard, Steffen

N1 - Publisher Copyright: © 2023

PY - 2024

Y1 - 2024

N2 - Purpose: This double-blinded randomized clinical trial aimed to evaluate the efficacy of injecting allogeneic adipose-derived mesenchymal stem cells (ASCs) into the lacrimal gland (LG) for the treatment of dry eye disease (DED) secondary to Sjögren's syndrome (SS). Methods: Fifty-four participants with severe DED secondary to SS were included and allocated to either ASCs (n = 20), vehicle (n = 20), or a non-randomized observation group (n = 14). The intervention groups received a single injection of either ASCs or an active comparator (vehicle, Cryostor® CS10) into the LG in one eye, while the observation group received lubricating eye drops only. The primary outcome measure was changes in Ocular Surface Disease Index (OSDI) score and secondary outcome measures were non-invasive tear break-up time, tear meniscus height, Schirmer's test, and Oxford score within a 12-month follow-up. Results: A significant reduction in OSDI score was observed in the ASCs and vehicle groups compared to the observation group. In addition, the ASCs group demonstrated a significant increase in non-invasive tear break-up time compared to the vehicle group at the 4-week follow-up and to the observation group at the 12-month follow-up. A significant improvement in ocular surface staining, tear osmolarity, and Schirmer test score from baseline was also observed in the ASCs group; however, these changes were not significant compared to the other groups. Conclusion: Improvement of subjective and objective signs and symptoms of DED was observed in both intervention groups following injection into the LG compared to the observation group. Future studies should investigate the mode-of-action of both injection treatments.

AB - Purpose: This double-blinded randomized clinical trial aimed to evaluate the efficacy of injecting allogeneic adipose-derived mesenchymal stem cells (ASCs) into the lacrimal gland (LG) for the treatment of dry eye disease (DED) secondary to Sjögren's syndrome (SS). Methods: Fifty-four participants with severe DED secondary to SS were included and allocated to either ASCs (n = 20), vehicle (n = 20), or a non-randomized observation group (n = 14). The intervention groups received a single injection of either ASCs or an active comparator (vehicle, Cryostor® CS10) into the LG in one eye, while the observation group received lubricating eye drops only. The primary outcome measure was changes in Ocular Surface Disease Index (OSDI) score and secondary outcome measures were non-invasive tear break-up time, tear meniscus height, Schirmer's test, and Oxford score within a 12-month follow-up. Results: A significant reduction in OSDI score was observed in the ASCs and vehicle groups compared to the observation group. In addition, the ASCs group demonstrated a significant increase in non-invasive tear break-up time compared to the vehicle group at the 4-week follow-up and to the observation group at the 12-month follow-up. A significant improvement in ocular surface staining, tear osmolarity, and Schirmer test score from baseline was also observed in the ASCs group; however, these changes were not significant compared to the other groups. Conclusion: Improvement of subjective and objective signs and symptoms of DED was observed in both intervention groups following injection into the LG compared to the observation group. Future studies should investigate the mode-of-action of both injection treatments.

KW - Dry eye disease

KW - Lacrimal gland

KW - Mesenchymal stem cells

KW - Regenerative medicine

KW - Stem cell therapy

U2 - 10.1016/j.jtos.2023.11.007

DO - 10.1016/j.jtos.2023.11.007

M3 - Journal article

C2 - 38049032

AN - SCOPUS:85179055846

VL - 31

SP - 1

EP - 8

JO - The Ocular Surface

JF - The Ocular Surface

SN - 1542-0124

ER -

ID: 377947926