Name: prospective, randomized, and controlled study of a human umbilical cord mesenchymal stem cell injection for treating diabetic foot ulcers
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Description: Watch this Scientific Journal Video about Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers at JoVE.com

The authors thank the Affiliated Hospital of Xuzhou Medical University for its cooperation, including the recruitment and follow-up of patients with diabetic foot wounds. The authors also thank the patients who participated in the patient needs survey during the design of this study.
The author(s) announce the receipt of the following financial support for research, authorship, and/or publication of this article: National Natural Science Foundation of China 82172224, Postgraduate Research &#38; Practice Innovation Program of Jiangsu Province (SJCX22-1271), and&#160;the Innovation &#38; Technology Commission (Health@InnoHK).

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
<ol>
	<li>Inclusion criteria:
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<ol>
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Y., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Effect+of+a+novel+macrophage-regulating+drug+on+wound+healing+in+patients+with+diabetic+foot+ulcers:+A+randomized+clinical+trial.">Effect of a novel macrophage-regulating drug on wound healing in patients with diabetic foot ulcers: A randomized clinical trial.</a> JAMA Network Open. 4 (9), e2122607 (2021).</li><li>Yarahmadi, A., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=The+effect+of+platelet-rich+plasma-fibrin+glue+dressing+in+combination+with+oral+vitamin+E+and+C+for+treatment+of+non-healing+diabetic+foot+ulcers:+A+randomized,+double-blind,+parallel-group,+clinical+trial.">The effect of platelet-rich plasma-fibrin glue dressing in combination with oral vitamin E and C for treatment of non-healing diabetic foot ulcers: A randomized, double-blind, parallel-group, clinical trial.</a> Expert Opinion on Biological Therapy. 21 (5), 687-696 (2021).</li><li>Virador, G. 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DFUs are a major global public health problem and a key cause of lower limb amputations and poor health-related quality of life19,20. 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...

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 world2,3,4,5.
Recently, stem cells have flourished as a therapy due to their pluripotency, self-renewal, and ability to promote the secretion of regenerative cytokines6,7. A previous clinical experiment showed that fat-derived stem cell gels had a positive effect on the treatment of foot ulcers in chronic diabetes8. The authors verified the effectiveness of using stem cells to treat diabetic wounds in 59 patients. At week 12, the rate of complete wound closure in the treatment and control groups was 82% and 53%, respectively, which indicates that stem cells are effective for the treatment of refractory diabetic wounds. Overall, the ability of stem cells to regenerate, replace, repair, and differentiate has given infinite hope to the life science community9.
In 2008, Dulchavsky et al.10 used grafts containing autologous bone marrow stromal cells (BMSCs) to treat 20 cases of non-healing wounds of different causes. Histological examinations showed that the skin wounds of 18 patients were completely re-epithelialized. Similarly, the use of allogeneic non-diabetic mesenchymal stem cells (MSCs) in gelatin scaffolds for the treatment of nonunion diabetic wounds can promote angiogenesis, increase re-epithelialization, and reduce the ulcer area11. However, there are few cases of stem cell treatment of diabetic foot wounds in domestic and foreign clinical research studies; most are only case reports or exploratory clinical research lacking a strict experimental design, and there are few large samples with good design or randomized controlled clinical trials. As stem cells are not common drugs or biological products, the preparation methods and quality controls differ between studies. Data from one study may not fully reflect the safety of all stem cells from the same species. Therefore, we further summarized the relevant basic research and preclinical experiments with human umbilical cord mesenchymal stem cells (HUCMSCs) and systematically evaluated the safety and efficacy of their clinical application. On this basis, the injection of mesenchymal stem cells from the human umbilical cord to repair diabetic foot wounds was developed as a treatment. This study aims to verify the efficacy and safety of stem cell repair of diabetic foot wounds in clinical use.
In summary, stem cell therapy has a broad spectrum of applications and great potential and represents a promising new medical treatment method. With the continued support of the National Natural Science Foundation of China (No. 81571901, No. 81501671, and No. 82172224), we conducted a series of studies on the treatment of diabetic wounds with HUCMSCs. We have published more than 20 related articles in the Journal of Investigative Dermatology, Stem Cell Research and Therapy, and Cell Death and Disease and have applied for three national invention patents, thus accumulating a large foundation of research12,13. Here, we provide a standard approach to evaluate the injection of HUCMSCs for diabetic foot wound repair. This standard procedure has been approved by Chinese drug clinical trials (Trial registration number: Chinese drug clinical trials: MR-32-21-015759, [Initial Release: 10/20/2021]).

<table border="1" fo:keep-together.within-page="1" fo:keep-with-next.within-page="always">
	<tbody>
		<tr>
			<td>Silver Iin Wound Dressing</td>
			<td>Shandong Cheerain Medical Co.,Ltd.&#160;</td>
			<td>20152640521</td>
			<td>Sterile silver ion dressing for medical use (Type F) 10 cm x 10 cm</td>
		</tr>
		<tr>
			<td>Human Umbilical Cord Mesenchymal Stem Cells Injection</td>
			<td>Shandong Qilu Cell Therapy Engineering Technology Co., Ltd.</td>
			<td>32183185-X</td>
			<td>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.</td>
		</tr>
		<tr>
			<td>Sterile mesh film transparent dressing</td>
			<td>Smith &#38; Nephew</td>
			<td>20162644490</td>
			<td>Sterile mesh film transparent dressing (used for wound area measurement) 6 cm x 7 cm</td>
		</tr>
	</tbody>
</table>

prospective, randomized, and controlled study of a human umbilical cord mesenchymal stem cell injection for treating diabetic foot ulcers

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.

At present, our research is still in the patient recruitment phase, and we have now completed three patients in the HUCMSCs treatment group and three patients in the control group with silver ion dressings, giving a total of six patients with chronic diabetic foot wounds. The average size of the ulcer area of a patient in the HUCMSCs treatment group was 3.5 cm2, and this was reduced to 2.6 cm2, 1.8 cm2, and 1.25 cm2 on the 8th, 15th, and 22nd days after treatment with HUCMSCs (...

Watch this Scientific Journal Video about Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers at JoVE.com

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

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.

With the development of society and the economy, the incidence of diabetic foot ulcers continues to increase. Currently, conventional debridement with ...

Our protocol aim to provide a uniform model for system cells injection to treat diabetic ulcers to evaluate the safety and effectiveness of this treatment. We provide a research standard for stem cells for treating diabetic ulcer, which has the advantages of the high consistencies and the repeatability. Diabetic ulcer is just one of the representative of common refractory ulcer.We hope to apply stem cells to the treatment of other ulcers or other diseases through this protocol. When using this method to treat the body ulcers, it is necessary to ensure the safety of the source of stem cells and to monitor whether patients experience immune rejection. Through visual demonstration, we hope to provide standard and references for other researchers in the treatment of diabetic ulcers or other refractory wounds.Begin by disinfecting the wound site with povidone iodine solution. Remove any necrotic tissue using surgical scissors. Now use the syringe to aspirate 50 milliliters of saline to clean the wound surface.Measure the wound area using the sterile foil edge hook method. Apply the sterile film transparent dressing to the wound surface. Outline the shape of the wound surface with a marker to calculate the wound area.In the stem cell therapy group, inject the human umbilical cord mesenchymal stem cells into the wound periphery and base. Cover the wound surface with an appropriately sized sterile dressing and then bandage it. In the conventional wound treatment group, once the site has been cleaned, measured, and marked as described earlier, cover the wound with a silver ion dressing before bandaging it.The wounds treated with the human umbilical cord mesenchymal stem cells reduced in size from 3.5 square centimeters to 2.6 square centimeters on the eighth day. By the 15th day, the wound size was 1.8 square centimeters. It was further reduced to 1.25 square centimeters on the 22nd day post-treatment.The wounds treated with a conventional silver ion dressing also decreased in size from 1.25 square centimeters to 0.875 square centimeters on the eighth day. By the 15th day, the wound size was 0.8 square centimeters. A slight reduction to 0.75 square centimeters was seen by the 22nd day.The critical step of this experiment is to inject stem cells into the wound at a fixed point and a fixed time. Moreover, long-term followup is required for laboratory tests. According to the biological characteristics of stem cells, following this procedure, it can be applied to burn wounds, infection wounds, and et cetera, which plays an important role in the research of wound healing.After the development of stem cells technology for treating diabetic ulcers, we believe it can play a huge role in most wound treatment through its ability to secrete growth factors and vasoactive factors effectively.

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