Safety and Efficacy of Autologous Platelet Rich Plasma and Platelet Poor Plasma Eye Drops in the Treatment of Ocular Graft-Versus-Host Disease
Status: Withdrawn
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The purpose of this study is to evaluate the safety and efficacy of autologous Platelet Rich Plasma (PRP) and Platelet Poor Plasma (PPP) eye drops four times a day in the treatment of ocular graft versus host disease (O-GVHD). In addition to their current medication (except autologous serum drops), patients will receive PRP and PPP drops.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Age ≥18 years.
• Willing and able to provide written informed consent.
• Willing and able to comply with study assessments for the full duration of the study.
• Diagnosis of ocular GVHD.
• Minimum corneal fluorescein staining of 4 (NEI grading scheme, 0-15) in at least one eye.
• In good stable overall health.
Locations
United States
Pennsylvania
UPMC Eye Center
Pittsburgh
Time Frame
Start Date: 2016-12
Completion Date: 2018-09
Treatments
Experimental: PRP and PPP
PRP eye drops and PPP eye drops will be prepared from patient's own blood by Magellan technology. Patients will receive eye drops in sterile amber glass droppers. Patients will be instructed to keep refrigerated each bottle after opening for 7 days and keep frozen the unopened bottles up to 30 days.
Authors
Related Therapeutic Areas
Sponsors
Leads: Ladan Espandar