PMID- 32640498
OWN - NLM
STAT- MEDLINE
DCOM- 20210802
LR  - 20210802
IS  - 1098-1101 (Electronic)
IS  - 0733-2459 (Print)
IS  - 0733-2459 (Linking)
VI  - 35
IP  - 4
DP  - 2020 Aug
TI  - Pilot study of a new online extracorporeal photopheresis system in patients with 
      steroid refractory or dependent chronic graft vs host disease.
PG  - 342-350
LID - 10.1002/jca.21804 [doi]
AB  - BACKGROUND: A new protocol has been developed on the Amicus Separator that 
      enables the device to perform online extracorporeal photopheresis (ECP) 
      procedures when used in conjunction with the Phelix photoactivation device and 
      associated disposable kit. The objective of this study was to evaluate the safety 
      and performance of the Amicus ECP System in adult subjects with 
      steroid-refractory or dependent chronic graft vs host disease (cGVHD). STUDY 
      DESIGN AND METHODS: Eight subjects with mild to severe cGVHD underwent 31 
      procedures. Subject safety evaluations were performed pre and post procedure and 
      adverse events (AEs) were recorded during treatment and 24 hours after the last 
      procedure. In vitro evaluations of the treated cells included hematology counts 
      and lymphocyte apoptosis, viability and proliferation as measures for ECP 
      procedure validation. RESULTS: For n = 23 evaluable procedures, median (range) 
      procedure time was 88 (78-110) minutes, during which 2.9 (0.6-4.7) x 10(9) TNCs 
      (approximately 90% MNCs) were treated and reinfused to the subjects. All subject 
      safety evaluations (vitals, cell counts, plasma hemoglobin and bacterial and 
      endotoxin testing) were within expected ranges. All device or procedure related 
      AEs were mild in nature. After 24 hours in culture, 86 (52-98)% of treated 
      lymphocytes were apoptotic compared to 27 (15-51)% in controls. Inhibition of 
      lymphocyte proliferation was >91% in all procedures. CONCLUSION: ECP procedures 
      were safely completed in adult subjects with SR-cGVHD treated using the new 
      online Amicus ECP system.
CI  - (c) 2020 The Authors. Journal of Clinical Apheresis published by Wiley Periodicals 
      LLC.
FAU - Radwanski, Katherine
AU  - Radwanski K
AUID- ORCID: 0000-0002-5680-6965
AD  - Fresenius Kabi USA, Lake Zurich, Illinois, USA.
FAU - Burgstaler, Edwin
AU  - Burgstaler E
AUID- ORCID: 0000-0002-2578-1822
AD  - Division of Transfusion Medicine, Department of Laboratory Medicine and 
      Pathology, Mayo Clinic, Rochester, Minnesota, USA.
FAU - Weitgenant, Jennifer
AU  - Weitgenant J
AD  - Fresenius Kabi USA, Lake Zurich, Illinois, USA.
FAU - Dale, Heather
AU  - Dale H
AD  - Division of Transfusion Medicine, Department of Laboratory Medicine and 
      Pathology, Mayo Clinic, Rochester, Minnesota, USA.
FAU - Heber, Cheryl
AU  - Heber C
AD  - Fresenius Kabi USA, Lake Zurich, Illinois, USA.
FAU - Winters, Jeffrey
AU  - Winters J
AD  - Division of Transfusion Medicine, Department of Laboratory Medicine and 
      Pathology, Mayo Clinic, Rochester, Minnesota, USA.
LA  - eng
GR  - Fresenius Kabi/
PT  - Journal Article
DEP - 20200708
PL  - United States
TA  - J Clin Apher
JT  - Journal of clinical apheresis
JID - 8216305
RN  - 0 (Steroids)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Apoptosis
MH  - Cell Proliferation
MH  - Cell Survival
MH  - Female
MH  - Glomerular Filtration Rate
MH  - Graft vs Host Disease/*therapy
MH  - Hematopoietic Stem Cell Transplantation/adverse effects
MH  - Humans
MH  - In Vitro Techniques
MH  - Internet
MH  - Lymphocytes/cytology
MH  - Male
MH  - Middle Aged
MH  - Patient Safety
MH  - Photochemistry
MH  - Photopheresis/*methods
MH  - Pilot Projects
MH  - Risk
MH  - Steroids/*therapeutic use
MH  - Treatment Outcome
PMC - PMC7496115
OTO - NOTNLM
OT  - Amicus
OT  - ECP
OT  - cGVHD
COIS- Katherine Radwanski, Jennifer Weitgenant, and Cheryl Heber are employees of 
      Fresenius Kabi.
EDAT- 2020/07/09 06:00
MHDA- 2021/08/03 06:00
PMCR- 2020/09/17
CRDT- 2020/07/09 06:00
PHST- 2019/12/20 00:00 [received]
PHST- 2020/03/17 00:00 [revised]
PHST- 2020/06/09 00:00 [accepted]
PHST- 2020/07/09 06:00 [pubmed]
PHST- 2021/08/03 06:00 [medline]
PHST- 2020/07/09 06:00 [entrez]
PHST- 2020/09/17 00:00 [pmc-release]
AID - JCA21804 [pii]
AID - 10.1002/jca.21804 [doi]
PST - ppublish
SO  - J Clin Apher. 2020 Aug;35(4):342-350. doi: 10.1002/jca.21804. Epub 2020 Jul 8.