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Copyright ©The Author(s) 2024.
World J Diabetes. Jun 15, 2024; 15(6): 1162-1177
Published online Jun 15, 2024. doi: 10.4239/wjd.v15.i6.1162
Table 1 Outcome of clinical trials on adipose-derived stem cells treatment for diabetic foot
Ref.
Country
Cell type
Condition
Intervention
Cell count
Follow-up
Enrollment
Outcome
Mrozikiewicz-Rakowska et al[55], 2023PolandAllogeneicUlcerHydrogel2.5 × 106 cells49 d47The time required for a 50% reduction in wound size was 17.6 ± 1.5 d (P = 0.029)
Lee et al[41], 2012KoreaAllogeneicIschemiaIntramuscular injection5 × 106 cells6 months1566.7% of patients showed clinical improvement, with enhanced pain relief, increased claudication walking distance, and the development of vascular collateral networks
Moon et al[33], 2019KoreaAllogeneicUlcerHydrogel1 × 106 cells per film12 wk59Wound closure reached 73% by week 8 and increased to 82% by week 12, with a median closure time of 28.5 d
Yastı et al[80], 2023TürkiyeAutologousUlcer3D-AMHAT15-25 mL of fat12 wk20All wounds, except one, were fully epithelialized by the ninth week, with a mean time to complete closure of 32.20 d
Bajuri et al[81], 2023MalaysiaAutologousUlcer3D-AMHAT20 mL of fat12 wk10Within 12 wk, complete healing was observed in 70% of the patients
Bura et al[31], 2014FranceAutologousIschemiaIntramuscular injection1 × 108 cells6 months7All ulcers showed 100% improvement after 6 months, with three completely healed
Uzun et al[82], 2021TürkiyeAllogeneicUlcerInjection6 × 106 cells4 years2090% healing, with no adverse reactions
Nolan et al[83], 2022United KingdomAutologousUlcerIntramuscular injection/4 wk18Increased mean microvessel density by + 32% to + 45% at 1 wk (P = 0.035)
Dreifuss et al[84], 2017United StatesAutologousPedal atrophyInjection/12 months23Dermal thickness increased significantly post-injection, persisting through 24 months (P < 0.05)
Kress et al[85], 2023United StatesAutologousUlcerInjection13.9 mL of fat9.3 months10Achieved full clinical recovery with no reulceration
Carstens et al[53], 2021United StatesAutologousUlcerSubcutaneous injection3 × 107 cells12 months63At 6 months, 51 subjects achieved complete closure, and 8 had closure of ≥ 75%
Nilforoushzadeh et al[86], 2020IranAutologousUlcerEngineered skin graft/21 wk5There was a significant increase (P ≤ 0.05) in both skin thickness and vascular bed density
Lonardi et al[87], 2019ItalyAutologousMinor amputationsInjection10-30 mL of fat6 months114At 6 months, 80% of the feet showed healing (P = 0.0064)
Carstens et al[42], 2017United StatesAutologousIschemiaIntramuscular injection/12 months10All patients showed clinical improvement (rest pain, claudication, ABI)
Zollino et al[88], 2019ItalyAutologousUlcerInjection15 mL of fat24 wk16The average wound healing time was 17.5 ± 7.0 wk (P < 0.036)
Raposio et al[43], 2018ItalyAutologousIschemiaSubcutaneous injection5 × 105 cells6 months7After 6 months, all patients demonstrated complete wound healing
Namgoong et al[89], 2010KoreaAutologousUlcerHydrogel30-50 mL of fat16 wk20Eight out of 10 patients (80%) achieved complete wound healing after 16 wk, with a reduction in wound area by 4.3 ± 1.0 cm² (P = 0.043)
Han et al[90], 2010KoreaAutologousUlcerSubcutaneous injection4.0-8.0 × 106 cells8 wk54100% healing was achieved
Smith et al[91], 2020United KingdomAutologousUlcerInjection2 mL of fat/cm²21 months18There was no difference between any of the groups in terms of clinical outcomes
Gennai et al[92], 2021ItalyAutologousMinor amputationsInjection10-30 mL of fat6 months114The average hospital length of stay was 16.2 d (P = 0.025)
Table 2 Comparison of adipose-derived stem cells administration methods for diabetic foot treatment
Method
Advantages
Disadvantages
Intravenous infusionTargets multiple areasCells may get trapped in the lungs
Arterial injectionDirect delivery to the footTechnically challenging and risk of blood vessel issues
Muscular injectionDirectly reaches wound, good for poor blood flow, improves cell survival and nerve regenerationLess effective for wounds away from muscle
Local injectionHigh cell concentration at the woundRisk of uneven cell spread and clumping