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- Title
Results of the Phase 1 Open-Label Safety Study of Umbilical Cord Lining Mesenchymal Stromal/Stem Cells (Corlicyte ®) to Heal Chronic Diabetic Foot Ulcers.
- Authors
Low Wang, Cecilia C.; Chong, Tae; Moore, Garrett; Echalier, Benjamin; Haakonsen, Nicola; Carter Jr., James E.; Mathes, David; Hsia, Judith; Phan, Toan Thang; Lim, Ivor J.; Freed, Brian M.
- Abstract
Background: Mesenchymal stromal/stem cells (MSCs) play a critical role in wound healing. Corlicyte® is an MSC product derived from allogeneic umbilical cord tissue donated under an institutional review board-approved protocol and processed in accordance with section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. This open-label phase 1 trial was performed under a United States Food and Drug Administration Investigational New Drug Application to establish the safety and tolerability of Corlicyte® in patients with diabetes and chronic diabetic foot ulcer (DFU). Methods: Escalating doses were applied topically twice a week for up to 8 weeks after ulcer debridement, wound photography, and measurement. Subjects were followed for 4 weeks after the treatment phase. Adverse events were assessed at every visit. Results: Nine subjects in 2 dosing cohorts completed the trial. No subjects experienced a serious adverse reaction to Corlicyte® or the development of anti-human leukocyte antigen (HLA) antibodies. Sixty percentage of subjects in the lower dose cohort experienced ulcer closure by Day 70 of follow-up, while the mean ulcer size was reduced by 54–67% in the other subjects. Conclusions: Topical administration of Corlicyte®, a novel biologic therapy consisting of allogeneic umbilical cord lining MSCs, appeared safe and tolerable and resulted in a significant decrease in ulcer area, demonstrating its potential as a therapy for healing of chronic DFU.
- Subjects
DIABETIC foot; UMBILICAL cord; STEM cells; TOPICAL drug administration; INVESTIGATIONAL drugs
- Publication
Biomedicines, 2024, Vol 12, Issue 6, p1375
- ISSN
2227-9059
- Publication type
Article
- DOI
10.3390/biomedicines12061375