Safety and feasibility of mesenchymal stem cell therapy in patients with aqueous deficient dry eye disease
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Safety and feasibility of mesenchymal stem cell therapy in patients with aqueous deficient dry eye disease. / Møller-Hansen, Michael; Larsen, Ann Cathrine; Toft, Peter Bjerre; Lynggaard, Charlotte Duch; Schwartz, Camilla; Bruunsgaard, Helle; Haack-Sørensen, Mandana; Ekblond, Annette; Kastrup, Jens; Heegaard, Steffen.
I: The Ocular Surface, Bind 19, 2021, s. 43-52.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Safety and feasibility of mesenchymal stem cell therapy in patients with aqueous deficient dry eye disease
AU - Møller-Hansen, Michael
AU - Larsen, Ann Cathrine
AU - Toft, Peter Bjerre
AU - Lynggaard, Charlotte Duch
AU - Schwartz, Camilla
AU - Bruunsgaard, Helle
AU - Haack-Sørensen, Mandana
AU - Ekblond, Annette
AU - Kastrup, Jens
AU - Heegaard, Steffen
PY - 2021
Y1 - 2021
N2 - Purpose: To evaluate the safety and feasibility of injecting allogeneic adipose-derived mesenchymal stem cells (ASCs) into the lacrimal gland (LG) as a treatment of aqueous deficient dry eye disease (ADDE). Methods: In this open-label, 5-visit clinical trial (baseline, treatment and weeks 1, 4 and 16) seven subjects with ADDE received one transconjunctival injection of allogeneic ASCs into the LG in one eye. The ASC product contained 22 million ASCs/ml and the injected volume was maximally 50% of the LG volume as determined on magnetic resonance imaging (MRI). Treatment related adverse events (AEs) were assessed at each visit (primary endpoint). Ocular Surface Disease Index (OSDI), tear osmolarity, tear film breakup time (TBUT), corneal staining (Oxford grade) and Schirmer's I test were assessed at each timepoint. Results: No AEs related to the study treatment were observed. Mean follow-up time was 126 days after treatment. The mean OSDI score decreased from 58.9 ± 20.6 at baseline to 34.1 ± 21.6 (p < 0.002). In the study eye mean tear osmolarity decreased from 312.9 ± 10.4 to 291.6 ± 10.9 mosm/l (p < 0.002), mean TBUT increased from 3.7 ± 1.5 to 7.1 ± 1.9 s (p < 0.002), mean Schirmer's I test increased from 4.6 ± 0.7 to 8.1 ± 3.1 mm/5 min (p < 0.03), while mean Oxford grade showed a trend towards a decrease from 2.4 ± 0.7 to 1.3 ± 1 (p < 0.10). Conclusion: Our trial suggests that injection of allogeneic ASCs into the LG is a safe and feasible treatment of severe ADDE. A randomized placebo-controlled trial aimed at elucidating the therapeutic effect of allogeneic ASCs in a larger patient cohort from our research group is currently underway.
AB - Purpose: To evaluate the safety and feasibility of injecting allogeneic adipose-derived mesenchymal stem cells (ASCs) into the lacrimal gland (LG) as a treatment of aqueous deficient dry eye disease (ADDE). Methods: In this open-label, 5-visit clinical trial (baseline, treatment and weeks 1, 4 and 16) seven subjects with ADDE received one transconjunctival injection of allogeneic ASCs into the LG in one eye. The ASC product contained 22 million ASCs/ml and the injected volume was maximally 50% of the LG volume as determined on magnetic resonance imaging (MRI). Treatment related adverse events (AEs) were assessed at each visit (primary endpoint). Ocular Surface Disease Index (OSDI), tear osmolarity, tear film breakup time (TBUT), corneal staining (Oxford grade) and Schirmer's I test were assessed at each timepoint. Results: No AEs related to the study treatment were observed. Mean follow-up time was 126 days after treatment. The mean OSDI score decreased from 58.9 ± 20.6 at baseline to 34.1 ± 21.6 (p < 0.002). In the study eye mean tear osmolarity decreased from 312.9 ± 10.4 to 291.6 ± 10.9 mosm/l (p < 0.002), mean TBUT increased from 3.7 ± 1.5 to 7.1 ± 1.9 s (p < 0.002), mean Schirmer's I test increased from 4.6 ± 0.7 to 8.1 ± 3.1 mm/5 min (p < 0.03), while mean Oxford grade showed a trend towards a decrease from 2.4 ± 0.7 to 1.3 ± 1 (p < 0.10). Conclusion: Our trial suggests that injection of allogeneic ASCs into the LG is a safe and feasible treatment of severe ADDE. A randomized placebo-controlled trial aimed at elucidating the therapeutic effect of allogeneic ASCs in a larger patient cohort from our research group is currently underway.
KW - Dry eye disease
KW - Mesenchymal stem cells
KW - Regenerative medicine
KW - Stem cell therapy
U2 - 10.1016/j.jtos.2020.11.013
DO - 10.1016/j.jtos.2020.11.013
M3 - Journal article
C2 - 33253910
AN - SCOPUS:85096967228
VL - 19
SP - 43
EP - 52
JO - The Ocular Surface
JF - The Ocular Surface
SN - 1542-0124
ER -
ID: 255105277