PMID- 34994777
OWN - NLM
STAT- MEDLINE
DCOM- 20220126
LR  - 20220126
IS  - 2164-2591 (Electronic)
IS  - 2164-2591 (Linking)
VI  - 11
IP  - 1
DP  - 2022 Jan 3
TI  - Exploratory Phase II Multicenter, Open-Label, Clinical Trial of ST266, a Novel 
      Secretome for Treatment of Persistent Corneal Epithelial Defects.
PG  - 8
LID - 10.1167/tvst.11.1.8 [doi]
LID - 8
AB  - OBJECTIVE: An exploratory phase II, multicenter, open-label, clinical trial 
      (NCT03687632) was conducted to evaluate the safety and effectiveness in treating 
      persistent corneal epithelial defects (PEDs) with ST266, a proprietary novel 
      multi-cytokine platform biologic solution secreted by cultured Amnion-derived 
      Multipotent Progenitor (AMP) cells. METHODS: Subjects with a PED were treated 
      with ST266 eye drops 4 times daily for 28 days, then followed for 1 week. Safety 
      was assessed by monitoring of adverse events (AEs) and serious adverse events 
      (SAEs). Efficacy was assessed by measuring the area of the PED by slit lamp 
      biomicroscopy. Tolerability of ST266, percentage of eyes with complete healing, 
      reduction in area of the epithelial defect, and maintenance of a reduction in the 
      area of the epithelial defect 7 days after treatment were recorded. RESULTS: 
      Thirteen patients were enrolled into the trial at one of eight sites. The first 
      patient withdrew after 5 days. The remaining 12 patients with PEDs with median 
      duration of 39 days (range = 12 to 393 days) completed treatment. Ten of the 12 
      eyes had been refractory to treatment with various conventional therapies prior 
      to enrollment. After 28 days of treatment, there was a significant decrease in 
      mean PED area compared with baseline (66.4% +/- 35.3%, P = 0.001). At follow-up, 1 
      week after completion of treatment, on day 35, the PED area was further reduced 
      by 78.8% +/- 37.5% (P = 0.01) compared with baseline. During 28 days of treatment, 
      5 eyes (41.7%) had complete wound closure. There were no AEs of concern thought 
      to be related to the drug, and no SAEs were noted. CONCLUSIONS: In this trial, we 
      found ST266 eye drops might promote corneal epithelization, thereby reducing the 
      PED area, including in refractory cases in a wide range of etiologies. ST266 was 
      well-tolerated by most patients.
FAU - Jeng, Bennie H
AU  - Jeng BH
AD  - Department of Ophthalmology and Visual Sciences, University of Maryland School of 
      Medicine, Baltimore, Maryland, USA.
FAU - Hamrah, Pedram
AU  - Hamrah P
AD  - Department of Ophthalmology, Tufts University School of Medicine, Boston, 
      Massachusetts, USA.
FAU - Kirshner, Ziv Z
AU  - Kirshner ZZ
AD  - Noveome Biotherapeutics, Inc., Pittsburgh, Pennsylvania, USA.
FAU - Mendez, Benjamin C
AU  - Mendez BC
AD  - Noveome Biotherapeutics, Inc., Pittsburgh, Pennsylvania, USA.
FAU - Wessel, Howard C
AU  - Wessel HC
AD  - Noveome Biotherapeutics, Inc., Pittsburgh, Pennsylvania, USA.
FAU - Brown, Larry R
AU  - Brown LR
AD  - Noveome Biotherapeutics, Inc., Pittsburgh, Pennsylvania, USA.
FAU - Steed, David L
AU  - Steed DL
AD  - Noveome Biotherapeutics, Inc., Pittsburgh, Pennsylvania, USA.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Transl Vis Sci Technol
JT  - Translational vision science & technology
JID - 101595919
RN  - 0 (Ophthalmic Solutions)
SB  - IM
MH  - Amnion
MH  - *Corneal Diseases/drug therapy
MH  - Humans
MH  - Ophthalmic Solutions
MH  - *Secretome
MH  - Wound Healing
PMC - PMC8742509
COIS- Disclosure: B.H. Jeng, None; P. Hamrah, Anida (C), Dompe (C, I), Neuroptika (C), 
      Nveome (I); Z.Z. Kirshner, Noveome Biotherapeutics, Inc. (E); B.C. Mendez, 
      Noveome Biotherapeutics, Inc. (E); H.C. Wessel, Noveome Biotherapeutics, Inc. 
      (E); L.R. Brown, Noveome Biotherapeutics, Inc. (E); D.L. Steed, Noveome 
      Biotherapeutics, Inc. (E)
EDAT- 2022/01/08 06:00
MHDA- 2022/01/27 06:00
PMCR- 2022/01/07
CRDT- 2022/01/07 12:22
PHST- 2022/01/07 12:22 [entrez]
PHST- 2022/01/08 06:00 [pubmed]
PHST- 2022/01/27 06:00 [medline]
PHST- 2022/01/07 00:00 [pmc-release]
AID - 2778236 [pii]
AID - TVST-21-3937 [pii]
AID - 10.1167/tvst.11.1.8 [doi]
PST - ppublish
SO  - Transl Vis Sci Technol. 2022 Jan 3;11(1):8. doi: 10.1167/tvst.11.1.8.