Results of the Phase 1 Open-Label Safety Study of Umbilical Cord Lining Mesenchymal Stromal/Stem Cells (Corlicyte®) to Heal Chronic Diabetic Foot Ulcers

Cecilia C Low Wang; Tae Chong; Garrett Moore; Benjamin Echalier; Nicola Haakonsen; James E Carter Jr; David Mathes; Judith Hsia; Toan Thang Phan; Ivor J Lim; Brian M Freed

doi:10.3390/biomedicines12061375

Results of the Phase 1 Open-Label Safety Study of Umbilical Cord Lining Mesenchymal Stromal/Stem Cells (Corlicyte^®) to Heal Chronic Diabetic Foot Ulcers

Biomedicines. 2024 Jun 20;12(6):1375. doi: 10.3390/biomedicines12061375.

Authors

Cecilia C Low Wang¹, Tae Chong², Garrett Moore³, Benjamin Echalier⁴, Nicola Haakonsen⁴, James E Carter Jr⁵, David Mathes⁶, Judith Hsia^{7

8}, Toan Thang Phan⁹, Ivor J Lim⁹, Brian M Freed¹⁰

Affiliations

¹ Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.
² Division of Plastic and Reconstructive Surgery, Department of Surgery, School of Medicine, Virginia Commonwealth University, Richmond, VA 23298, USA.
³ Department of Orthopedics, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.
⁴ University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.
⁵ Department of Cardiovascular Medicine, Miller Family Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, OH 44195, USA.
⁶ Division of Plastic and Reconstructive Surgery, Department of Surgery, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.
⁷ Division of Cardiology, Department of Medicine, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.
⁸ CPC Clinical Research, Aurora, CO 80045, USA.
⁹ Cell Research Corporation Pte Ltd., Singapore 048943, Singapore.
¹⁰ Division of Allergy and Clinical Immunology, Department of Medicine, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.

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.

Keywords: diabetes; diabetic foot ulcer; mesenchymal stem cell; safety; stem cell.

Grants and funding

This trial was sponsored and supported by the University of Colorado Anschutz Medical Campus through a contract agreement with CellResearch Corporation, who provided the funding. The study funder did not impose any restrictions regarding the publication of the report.