The primary objective of the study is to investigate the safety and efficacy of KPI-012 compared to vehicle in participants who have a documented clinical diagnosis of PCED.
Approximately 90 participants diagnosed with persistent corneal epithelial defect (PCED) will be enrolled at multiple US centers in a study to assess the safety and efficacy of KPI-012, a topical mesenchymal stem cell secretome therapy. After an initial cohort of at least 2 participants to evaluate the safety of the high strength product, participants in the second cohort will be randomized to treatment with either the product or vehicle (placebo) for 8 weeks. The percentage of healing will be compared between groups treated with product and vehicle. Total length of study participation will be approximately 34 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
103
KPI-012 is a secretome product composed of biologically active components secreted from human bone marrow-derived mesenchymal stem cells
KPI-012 formulation with no active drug
Response status
Complete healing of the PCED and no corneal fluorescein staining in the area of the study lesion.
Time frame: Day 56
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Principal Investigator
Dothan, Alabama, United States
Principal Investigator
Irvine, California, United States
Principal Investigator
La Jolla, California, United States
Principal Investigator
Loma Linda, California, United States
Principal Investigator
Los Angeles, California, United States
Principal Investigator
Los Angeles, California, United States
Principal Investigator
Pasadena, California, United States
Principal Investigator
Rancho Cordova, California, United States
Principal Investigator
Aurora, Colorado, United States
Principal Investigator
Fort Collins, Colorado, United States
...and 36 more locations