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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.
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.
Afiliación
  • Low Wang CC; Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.
  • Chong T; Division of Plastic and Reconstructive Surgery, Department of Surgery, School of Medicine, Virginia Commonwealth University, Richmond, VA 23298, USA.
  • Moore G; Department of Orthopedics, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.
  • Echalier B; University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.
  • Haakonsen N; University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.
  • Carter JE; Department of Cardiovascular Medicine, Miller Family Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, OH 44195, USA.
  • Mathes D; Division of Plastic and Reconstructive Surgery, Department of Surgery, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.
  • Hsia J; Division of Cardiology, Department of Medicine, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.
  • Phan TT; CPC Clinical Research, Aurora, CO 80045, USA.
  • Lim IJ; Cell Research Corporation Pte Ltd., Singapore 048943, Singapore.
  • Freed BM; Cell Research Corporation Pte Ltd., Singapore 048943, Singapore.
Biomedicines ; 12(6)2024 Jun 20.
Article en En | MEDLINE | ID: mdl-38927582
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Biomedicines Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Suiza
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Biomedicines Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Suiza