PMID- 33253910
OWN - NLM
STAT- MEDLINE
DCOM- 20210624
LR  - 20220531
IS  - 1937-5913 (Electronic)
IS  - 1542-0124 (Linking)
VI  - 19
DP  - 2021 Jan
TI  - Safety and feasibility of mesenchymal stem cell therapy in patients with aqueous 
      deficient dry eye disease.
PG  - 43-52
LID - S1542-0124(20)30182-8 [pii]
LID - 10.1016/j.jtos.2020.11.013 [doi]
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.
CI  - Copyright (c) 2020 Elsevier Inc. All rights reserved.
FAU - Moller-Hansen, Michael
AU  - Moller-Hansen M
AD  - Department of Ophthalmology, Rigshospitalet-Glostrup, University of Copenhagen, 
      Denmark. Electronic address: michael.moeller-hansen@regionh.dk.
FAU - Larsen, Ann-Cathrine
AU  - Larsen AC
AD  - Department of Ophthalmology, Rigshospitalet-Glostrup, University of Copenhagen, 
      Denmark.
FAU - Toft, Peter Bjerre
AU  - Toft PB
AD  - Department of Ophthalmology, Rigshospitalet-Glostrup, University of Copenhagen, 
      Denmark.
FAU - Lynggaard, Charlotte Duch
AU  - Lynggaard CD
AD  - Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, 
      Rigshospitalet, University of Copenhagen, Denmark.
FAU - Schwartz, Camilla
AU  - Schwartz C
AD  - Department of Diagnostic Radiology, Rigshospitalet-Glostrup, University of 
      Copenhagen, Denmark.
FAU - Bruunsgaard, Helle
AU  - Bruunsgaard H
AD  - Department of Clinical Immunology, Rigshospitalet, And Department of Clinical 
      Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, 
      Denmark.
FAU - Haack-Sorensen, Mandana
AU  - Haack-Sorensen M
AD  - Cardiology Stem Cell Centre, The Heart Centre, Rigshospitalet, University of 
      Copenhagen, Denmark.
FAU - Ekblond, Annette
AU  - Ekblond A
AD  - Cardiology Stem Cell Centre, The Heart Centre, Rigshospitalet, University of 
      Copenhagen, Denmark.
FAU - Kastrup, Jens
AU  - Kastrup J
AD  - Cardiology Stem Cell Centre, The Heart Centre, Rigshospitalet, University of 
      Copenhagen, Denmark.
FAU - Heegaard, Steffen
AU  - Heegaard S
AD  - Department of Ophthalmology, Rigshospitalet-Glostrup, University of Copenhagen, 
      Denmark.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20201128
PL  - United States
TA  - Ocul Surf
JT  - The ocular surface
JID - 101156063
SB  - IM
MH  - *Dry Eye Syndromes/therapy
MH  - Feasibility Studies
MH  - Humans
MH  - *Mesenchymal Stem Cell Transplantation
MH  - *Mesenchymal Stem Cells
MH  - Tears
OTO - NOTNLM
OT  - Dry eye disease
OT  - Mesenchymal stem cells
OT  - Regenerative medicine
OT  - Stem cell therapy
EDAT- 2020/12/01 06:00
MHDA- 2021/06/25 06:00
CRDT- 2020/11/30 20:11
PHST- 2020/09/01 00:00 [received]
PHST- 2020/11/06 00:00 [revised]
PHST- 2020/11/24 00:00 [accepted]
PHST- 2020/12/01 06:00 [pubmed]
PHST- 2021/06/25 06:00 [medline]
PHST- 2020/11/30 20:11 [entrez]
AID - S1542-0124(20)30182-8 [pii]
AID - 10.1016/j.jtos.2020.11.013 [doi]
PST - ppublish
SO  - Ocul Surf. 2021 Jan;19:43-52. doi: 10.1016/j.jtos.2020.11.013. Epub 2020 Nov 28.