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

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

doi:10.3390/biomedicines12061375

Open AccessBrief Report

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

by

Cecilia C. Low Wang

^1,*

,

Tae Chong

²,

Garrett Moore

³,

Benjamin Echalier

⁴,

Nicola Haakonsen

⁴,

James E. Carter, Jr.

⁵,

David Mathes

⁶,

Judith Hsia

^7,8

,

Toan Thang Phan

⁹,

Ivor J. Lim

⁹ and

Brian M. Freed

¹⁰

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

^*

Author to whom correspondence should be addressed.

Biomedicines 2024, 12(6), 1375; https://doi.org/10.3390/biomedicines12061375

Submission received: 23 April 2024 / Revised: 4 June 2024 / Accepted: 14 June 2024 / Published: 20 June 2024

(This article belongs to the Special Issue Peripheral Artery Disease and Diabetic Foot Ulcer: From Bench to Clinic (2nd Edition))

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

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MDPI and ACS Style

Low Wang, C.C.; Chong, T.; Moore, G.; Echalier, B.; Haakonsen, N.; Carter, J.E., Jr.; Mathes, D.; Hsia, J.; Phan, T.T.; Lim, I.J.; et al. 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, 12, 1375. https://doi.org/10.3390/biomedicines12061375

AMA Style

Low Wang CC, Chong T, Moore G, Echalier B, Haakonsen N, Carter JE Jr., Mathes D, Hsia J, Phan TT, Lim IJ, et al. 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; 12(6):1375. https://doi.org/10.3390/biomedicines12061375

Chicago/Turabian Style

Low Wang, Cecilia C., Tae Chong, Garrett Moore, Benjamin Echalier, Nicola Haakonsen, James E. Carter, Jr., David Mathes, Judith Hsia, Toan Thang Phan, Ivor J. Lim, and et al. 2024. "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 12, no. 6: 1375. https://doi.org/10.3390/biomedicines12061375

APA Style

Low Wang, C. C., Chong, T., Moore, G., Echalier, B., Haakonsen, N., Carter, J. E., Jr., Mathes, D., Hsia, J., Phan, T. T., Lim, I. J., & Freed, B. M. (2024). 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, 12(6), 1375. https://doi.org/10.3390/biomedicines12061375

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

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