Efficacious Restoration of Intractable Trauma by Administration of Mesenchymal Stem/Stromal Cells and Hydrogel Composite: A Case Series

Abstract

Background and Objectives: Patients with intractable cutaneous injuries and complications such as severe ulcers and dysfunctions often result in unfavorable prognosis and burdensome possessions esthetically and psychosocially. This study aimed to evaluate the preliminary safety and efficacy outcomes of hyaluronic acid/placenta-derived mesenchymal stem/stromal cells (HA/P-MSCs) composite upon extensive traumas. Methods: The phase Ⅰ of the interventional study with four enrolled patients with refractory wounds and ulcerations was conducted. With the consent of the patients and approval of the ethics committee, continuous HA/P-MSC composite administration was conducted on the surface of wounds after surgical debridement. The dynamic changes in pathomorphology and therapeutic response were collectively recorded. Results: All the participants revealed efficacious remission with clinical-grade HA/P-MSC composite, including complete wound healing, elimination of inflammatory exudate and refractory ulcers, and regeneration of damaged tissues under sterile conditions. No untoward effects or recurrence were observed in the cases during treatment and the 24-month’s follow-up visit. Conclusion: Refractory wound management with HA/P-MSC composite was preliminarily safe and effective for the improvement of the outcomes of the patients. These findings provided new references for the treatment of the costliest and incurable diseases associated with cutaneous injuries. Clinical Trial Registration Number: ChiCTR2000038275