Intralesional allogeneic adipose-derived stem cells application in chronic diabetic foot ulcer: Phase I/2 safety study

Uzun, Erdal; Güney, Ahmet; Gönen, Zeynep Burçin; Özkul, Yusuf; Kafadar, İbrahim Halil; Günay, Mahmut; Mutlu, Mahmut

doi:10.1016/j.fas.2020.08.002

Cited by 41 publications

(39 citation statements)

References 34 publications

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“…The subgroup analysis indicated significant healing rates in both short-term follow-up and medium-term follow-up. Our result was consistent with recent studies [ 78 , 80 ]. In other words, wound healing progressed rapidly in the first six months after stem cell application.…”

Section: Discussionsupporting

confidence: 95%

Autologous Stem Cell Therapy for Chronic Lower Extremity Wounds: A Meta-Analysis of Randomized Controlled Trials

Chiang

Chiu

Kang

et al. 2021

Cells

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Lower extremity chronic wounds (LECWs) commonly occur in patients with diabetes mellitus (DM) and peripheral arterial disease (PAD). Autologous stem cell therapy (ASCT) has emerged as a promising alternative treatment for those who suffered from LECWs. The purpose of this study was to assess the effects of ASCT on LECWs. Two authors searched three core databases, and independently identified evidence according to predefined criteria. They also individually assessed the quality of the included randomized controlled trials (RCTs), and extracted data on complete healing rate, amputation rate, and outcomes regarding peripheral circulation. The extracted data were pooled using a random-effects model due to clinical heterogeneity among the included RCTs. A subgroup analysis was further performed according to etiology, source of stem cells, follow-up time, and cell markers. A total of 28 RCTs (n = 1096) were eligible for this study. The pooled results showed that patients receiving ASCT had significantly higher complete healing rates (risk ratio (RR) = 1.67, 95% confidence interval (CI) 1.28–2.19) as compared with those without ASCT. In the CD34+ subgroup, ASCT significantly led to a higher complete healing rate (RR = 2.70, 95% CI 1.50–4.86), but there was no significant difference in the CD34− subgroup. ASCT through intramuscular injection can significantly improve wound healing in patients with LECWs caused by either DM or critical limb ischemia. Lastly, CD34+ is an important cell marker for potential wound healing. However, more extensive scale and well-designed studies are necessary to explore the details of ASCT and chronic wound healing.

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Section: Discussionsupporting

confidence: 95%

Autologous Stem Cell Therapy for Chronic Lower Extremity Wounds: A Meta-Analysis of Randomized Controlled Trials

Chiang

Chiu

Kang

et al. 2021

Cells

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“…Based on the support of several pre-clinical experiments completed in animal models, some studies attempt to apply ASCs to clinical diabetes wound treatments in recent years. Several pilot studies ( 64 – 66 ) and randomized controlled trials ( 67 , 68 ) were identified through databases. The detailed information of included clinical studies is shown in Table 3 .…”

Section: Clinical Progress Of Ascs In Treating Diabetic Woundsmentioning

confidence: 99%

“…The dose of injection can be flexibly adjusted in different wounds. Allogenic purified ASCs are injected into the dermo-epidermal junction within 1×10 6 cells ( 68 ). The allogeneic ASCs sheets used in clinical studies, each with 1×10 6 cells, were directly applied as a wound dressing to the intervention group ( 68 ).…”

Section: Clinical Progress Of Ascs In Treating Diabetic Woundsmentioning

confidence: 99%

“…Allogenic purified ASCs are injected into the dermo-epidermal junction within 1×10 6 cells ( 68 ). The allogeneic ASCs sheets used in clinical studies, each with 1×10 6 cells, were directly applied as a wound dressing to the intervention group ( 68 ). Overall, ASCs treatment can be conducted on type I and type II diabetes patients with chronic untreated wounds, which exhibit better results in Wagner grade 2 wounds.…”

Section: Clinical Progress Of Ascs In Treating Diabetic Woundsmentioning

confidence: 99%

“…Besides, because of the long generation period of pure ASCs, patients can only receive autologous adipose-derived stromal vascular fraction (SVF) cells injection ( 65 ). Only one clinical study reported allogenic ASCs generation on diabetic wounds ( 68 ). In patients with autologous ASCs injected, 86% of patients achieved complete closure by the end of the sixth month ( 64 ).…”

Section: Clinical Progress Of Ascs In Treating Diabetic Woundsmentioning

confidence: 99%

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Adipose-Derived Stem Cells for the Treatment of Diabetic Wound: From Basic Study to Clinical Application

et al. 2022

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Diabetic wounds significantly affect the life quality of patients and may cause amputation and mortality if poorly managed. Recently, a wide range of cell-based methods has emerged as novel therapeutic methods in treating diabetic wounds. Adipose-derived stem cells (ASCs) are considered to have the potential for widespread clinical application of diabetic wounds treatment in the future. This review summarized the mechanisms of ASCs to promote diabetic wound healing, including the promotion of immunomodulation, neovascularization, and fibro synthesis. We also review the current progress and limitations of clinical studies using ASCs to intervene in diabetic wound healing. New methods of ASC delivery have been raised in recent years to provide a standardized and convenient use of ASCs.

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Advances in mesenchymal stromal cells and nanomaterials for diabetic wound healing

Hou

Zhang

2023

Diabetes Metabolism Res

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The delayed healing of diabetic wounds (DBW) will not only afflict patients, but also lead to amputation and even death in serious cases, which will create many negative effects on society and the country. Mesenchymal stromal cells (MSCs) have attracted extensive attention for their applications in chronic wound healing due to their excellent cytokine secretion ability and regulation of inflammation. Mesenchymal stromal cells can be used alone or wrapped with carrier/matrix and applied to enhance healing in the wound area. In this review, the etiology of the slow healing of DBW and the mechanism by which MSCs promote the healing of DBW were explored. In addition, we summarised the current research progress on the use of stromal cell-loaded biomaterials for wound healing in diabetic animal models. At the end of the article, we pointed out the challenges and improvement strategies for stromal cell therapy applied to DBW in future clinical practice. K E Y W O R D Sbiomaterials, diabetic foot ulcers, mesenchymal stromal cells, wound healing | INTRODUCTIONDiabetes mellitus is a group of metabolic diseases caused by a complex interplay of genetic, immune, and environmental factors. These diseases are characterised by chronic hyperglycaemia, which is caused by impaired insulin secretion or impaired insulin action, or both. 1 The long-term presence of hyperglycaemia can lead to chronic damage and dysfunction of various tissues. Diabetes can be divided into four types, namely type 1 diabetes, type 2 diabetes, other specific diabetes types, and gestational diabetes. 1 Type 1 diabetes is caused by the autoimmune system destroying the insulin-producing beta cells 1-4 ; type 2 diabetes is caused by insulin resistance in tissue cells, which allows less glucose to enter the cells and participate in the production of calories, while it allows more glucose to remain in the blood. 1,5 Gestational diabetes, on the other hand, is similar to type 2 diabetes in that it also stems from cellular insulin resistance, although its insulin resistance is due to hormones secreted by women during pregnancy. 1,6 Other specific diabetes is diabetes induced by specific etiologies, such as mumps, chronic pancreatitis, etc. or long-term steroid use. 1,6 In addition to hyperglycaemia, the clinical manifestations of diabetic patients are the typical "three more and one less", that is, drinking more, urinating more, eating more, and weight loss.

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Intralesional allogeneic adipose-derived stem cells application in chronic diabetic foot ulcer: Phase I/2 safety study

Cited by 41 publications

References 34 publications

Autologous Stem Cell Therapy for Chronic Lower Extremity Wounds: A Meta-Analysis of Randomized Controlled Trials

Autologous Stem Cell Therapy for Chronic Lower Extremity Wounds: A Meta-Analysis of Randomized Controlled Trials

Adipose-Derived Stem Cells for the Treatment of Diabetic Wound: From Basic Study to Clinical Application

Advances in mesenchymal stromal cells and nanomaterials for diabetic wound healing

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