Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers

Summary

The present protocol describes a prospective, randomized, controlled clinical study that evaluates a human umbilical cord mesenchymal stem cell injection for the treatment of chronic diabetic foot ulcers.

Abstract

With the development of society and the economy, the incidence of diabetic foot ulcers continues to increase. Currently, conventional debridement with dressing changes, hyperbaric oxygen, and vacuum sealing drainage are the main conservative treatments in clinical practice, and large wounds often require skin grafts or skin flap grafts. However, the treatment effects are not ideal, and many complications exist. Due to its complex pathogenesis, long treatment time, significant associated difficulties, and high disability rate, diabetic foot ulcers cause a heavy burden to patients, society, and medical care. According to our previous study, the pharmacological effects of human umbilical cord blood stem cells include nonspecific immune regulation; increased secretion of growth factors, vasoactive factors, and anti-inflammatory factors; enhanced anti-infectious ability of the human body; elimination of inflammation; and promotion of angiogenesis and ulcer healing. These effects suggest stem cells may be useful as an autologous or allogeneic treatment for refractory wounds. Therefore, we are conducting a clinical trial to treat refractory diabetic wounds with human umbilical cord stem cells in our clinic for diabetic foot ulcer patients who meet the inclusion criteria.

Introduction

Diabetes mellitus is a disease that affects individuals worldwide, and the World Health Organization (WHO) predicts that the number of people with diabetes mellitus will increase from 285 million in 2010 to 439 million in 2030¹. Diabetic foot ulcers (DFUs) are one of the most serious complications of diabetes and are main contributors to non-traumatic lower-extremity amputations across the world^2,3,4,5.

Recently, stem cells have flourished as a therapy due to their pluripotency, self-renewa....

Protocol

This prospective, single-center, randomized, controlled clinical study was approved by the Ethics Committee of the Affiliated Hospital of Xuzhou Medical University (XYFY2021-KL124-02). The study started in July 2021 and will continue until July 2023; 60 patients were recruited in this experiment. All patients signed an informed consent that allowed the researchers to use their clinical materials and biological data.

1. Recruitment of patients

1. Inclusion criteria: <.......

Discussion

DFUs are a major global public health problem and a key cause of lower limb amputations and poor health-related quality of life^19,20. At present, clinical management is still dominated by conventional debridement, hyperbaric oxygen therapy, vacuum sealing drainage (VSD), and conservative management. Larger wounds often require the transplantation of skin and skin flaps. Many patients suffer from long-term and repeated illnesses that cause severe physical and ment.......

Materials

Name	Company	Catalog Number	Comments
Silver Iin Wound Dressing	Shandong Cheerain Medical Co.,Ltd.	20152640521	Sterile silver ion dressing for medical use (Type F) 10 cm x 10 cm
Human Umbilical Cord Mesenchymal Stem Cells Injection	Shandong Qilu Cell Therapy Engineering Technology Co., Ltd.	32183185-X	Main components: human umbilical cord mesenchymal stem cells. Pharmacological effect: non-specific immunomodulator can enhance the secretion of growth factor, vasoactive factor and anti-inflammatory factor, improve the anti infection ability of human body, eliminate inflammation, promote angiogenesis and ulcer healing.
Sterile mesh film transparent dressing	Smith & Nephew	20162644490	Sterile mesh film transparent dressing (used for wound area measurement) 6 cm x 7 cm