PMID- 29070939
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 1177-5467 (Print)
IS  - 1177-5483 (Electronic)
IS  - 1177-5467 (Linking)
VI  - 11
DP  - 2017
TI  - Epiretinal membrane in a subject after transvitreal delivery of palucorcel (CNTO 
      2476).
PG  - 1797-1803
LID - 10.2147/OPTH.S140218 [doi]
AB  - BACKGROUND: A 70-year-old woman with retinitis pigmentosa experienced an 
      epiretinal membrane (ERM) formation and a tractional retinal detachment (RD) 
      following subretinal administration of palucorcel (CNTO 2476), a novel human 
      umbilical tissue-derived cell-based therapy, as part of a Phase I study. The 
      clinical course and results of a histologic examination of the ERM, which was 
      peeled during surgery to repair the RD, are described here. METHODS: In this 
      open-label, first-in-human, Phase I study (NCT00458575), two of seven subjects 
      developed RD, with an ERM formation reported in a woman receiving a targeted dose 
      of 3.0x10(5) palucorcel administered via a transvitreal route. A sample of the 
      ERM was retained for analysis following the ERM peeling procedure. Clinical 
      outcomes and ERM histology, based on immunocytochemistry analyses and 
      fluorescence in situ hybridization (FISH) staining, were evaluated. RESULTS: We 
      first noted the RD and formation of the ERM at 26 days after palucorcel 
      administration. The ERM was cellular and contained multiple cell types, including 
      Muller glial cells, immune cells, neurites, retinal pigment epithelial cells, and 
      palucorcel. The majority of cells were not actively dividing. FISH staining 
      showed a subset of Y chromosome-positive cells in the ERM from this woman, 
      supporting the presence of palucorcel (derived from umbilical cord tissue of male 
      neonate). Palucorcel did not differentiate into Muller glia, immune cells, 
      neurites, or retinal pigment epithelial cells. DISCUSSION: The development of an 
      ERM containing both subject (self) cells and palucorcel suggests that palucorcel 
      egress in the vitreal cavity after retinotomy may contribute to ERM formation and 
      RD and that an alternative delivery method will be required before further 
      studies are conducted. Subsequent clinical research using alternative subretinal 
      delivery methods for palucorcel in other indications suggests that membrane 
      development does not occur when palucorcel is delivered without retinal 
      perforation.
FAU - Spencer, Rand
AU  - Spencer R
AD  - Texas Retina Associates, Dallas, TX, USA.
FAU - Fisher, Steven
AU  - Fisher S
AD  - Molecular, Cellular, and Developmental Biology.
FAU - Lewis, Geoffrey P
AU  - Lewis GP
AD  - Center for the Study of Macular Degeneration Neuroscience Research Institute, 
      University of California, Santa Barbara, CA.
FAU - Malone, Terri
AU  - Malone T
AD  - Cell Therapy, Janssen Research & Development, LLC, Spring House, PA, USA.
LA  - eng
PT  - Journal Article
DEP - 20171006
PL  - New Zealand
TA  - Clin Ophthalmol
JT  - Clinical ophthalmology (Auckland, N.Z.)
JID - 101321512
PMC - PMC5640410
OTO - NOTNLM
OT  - cell therapy
OT  - epiretinal membrane
OT  - retinitis pigmentosa
COIS- Disclosure TM is an employee of Janssen. RS, SF, and GPL received research 
      funding from Janssen for this study. The authors report no other conflicts of 
      interest in this work.
EDAT- 2017/10/27 06:00
MHDA- 2017/10/27 06:01
PMCR- 2017/10/06
CRDT- 2017/10/27 06:00
PHST- 2017/10/27 06:00 [entrez]
PHST- 2017/10/27 06:00 [pubmed]
PHST- 2017/10/27 06:01 [medline]
PHST- 2017/10/06 00:00 [pmc-release]
AID - opth-11-1797 [pii]
AID - 10.2147/OPTH.S140218 [doi]
PST - epublish
SO  - Clin Ophthalmol. 2017 Oct 6;11:1797-1803. doi: 10.2147/OPTH.S140218. eCollection 
      2017.