Potential of Allogeneic Adipose-Derived Stem Cell–Hydrogel Complex for Treating Diabetic Foot Ulcers

Abstract

Mesenchymal stem cells (MSCs) may hold great promise for treating diabetic wounds. However, it is difficult for a clinician to use MSCs because they have not been commercialized. Meanwhile, a new commercial drug that contains adipose-derived stem cells (ASCs) has been developed. The purpose of this study was to examine the potential of allogeneic ASC sheets for treating diabetic foot ulcers. Fifty-nine patients with diabetic foot ulcers were randomized to either the ASC treatment group (n = 30) or a control group treated with polyurethane film (n = 29). Either an allogeneic ASC sheet or polyurethane film was applied on diabetic wounds weekly. These wounds were evaluated for a maximum of 12 weeks. Complete wound closure was achieved for 73% in the treatment group and 47% in the control group at week 8. Complete wound closure was achieved for 82% in the treatment group and 53% in the control group at week 12. The Kaplan-Meier median times to complete closure were 28.5 and 63.0 days for the treatment group and the control group, respectively. There were no serious adverse events related to allogeneic ASC treatment. Thus, allogeneic ASCs might be effective and safe to treat diabetic foot ulcers.

Evolution of ASC Immunophenotypical Subsets During Expansion In Vitro

“…By the same token, in the light of previous reports indicating lack of expression of Stro-1 [20] which in retrospect may be attributed to antibody sources and detection methods [58], we could consistently identify this marker-albeit at a wide span of levels-ranging from around 3% to more than 50%, supporting the findings of Ning et al and Zuk et al [59,60]. This may be of biological importance due to Stro-1 being involved in clonogenicity, homing, and angiogenesis [7]. Less dramatic, though still considerable differences in expression levels were noticed for other surface markers, including CD36, CD146, CD200, CD201, and CD271 [18,34,[61][62][63].…”

“…ASCs have been recognized to be highly biologically active, with regenerative roles in tissue formation, homeostasis, and immune regulation [3][4][5]. These unique properties render ASCs attractive in scenarios where the traditional approaches fall short of the desired therapeutic outcome, such as for chronic wounds, diabetic ulcers, osteoarthritis, ischemic heart disease, or type 1 diabetes, just to mention a few important areas [6][7][8][9][10]. Many ASC-based regimens have already progressed into clinical testing, and in the United States alone, more than 20 phase I and II clinical trials are currently being conducted (clinicaltrials.gov).…”

In Vitro Cultures of Adipose-Derived Stem Cells: An Overview of Methods, Molecular Analyses, and Clinical Applications

“…For instance, allogeneic ASC-derived sheets have been used in diabetic foot ulcers treatment. The experimental randomized clinical trial proved their efficiency in wound healing as compared with polyurethane films [129]. Refractory fistulas in patients with inflammatory bowel diseases are considered to be the next example of chronic and hard-to-heal wounds.…”

“…Potential of allogeneic adipose-derived stem cell-hydrogel complex for treating diabetic foot ulcer [129] Randomized, controlled trial 59 Diabetic foot ulcer Allogeneic Moon,…”

CXCR4‐SF1 bifunctional adipose‐derived stem cells benefit for the treatment of Leydig cell dysfunction‐related diseases

“…Compared with other MSCs, adipose‐derived stem cells (ADSCs) have the advantages of easy acquisition, reduced immunogenicity and an enhanced differentiation capacity . Many preclinical studies have studied the roles of ADSCs in promoting chronic diabetic wound healing and skin regeneration as well as the regeneration of cartilage tissue and liver cells . ADSC therapy for Leydig cell dysfunction‐related diseases has also been evaluated.…”