Adipose-derived stem cells in diabetic foot care: Bridging clinical trials and practical application

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], 2023	Poland	Allogeneic	Ulcer	Hydrogel	2.5 × 106 cells	49 d	47	The time required for a 50% reduction in wound size was 17.6 ± 1.5 d (P = 0.029)
Lee et al[41], 2012	Korea	Allogeneic	Ischemia	Intramuscular injection	5 × 106 cells	6 months	15	66.7% of patients showed clinical improvement, with enhanced pain relief, increased claudication walking distance, and the development of vascular collateral networks
Moon et al[33], 2019	Korea	Allogeneic	Ulcer	Hydrogel	1 × 106 cells per film	12 wk	59	Wound 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], 2023	Türkiye	Autologous	Ulcer	3D-AMHAT	15-25 mL of fat	12 wk	20	All 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], 2023	Malaysia	Autologous	Ulcer	3D-AMHAT	20 mL of fat	12 wk	10	Within 12 wk, complete healing was observed in 70% of the patients
Bura et al[31], 2014	France	Autologous	Ischemia	Intramuscular injection	1 × 108 cells	6 months	7	All ulcers showed 100% improvement after 6 months, with three completely healed
Uzun et al[82], 2021	Türkiye	Allogeneic	Ulcer	Injection	6 × 106 cells	4 years	20	90% healing, with no adverse reactions
Nolan et al[83], 2022	United Kingdom	Autologous	Ulcer	Intramuscular injection	/	4 wk	18	Increased mean microvessel density by + 32% to + 45% at 1 wk (P = 0.035)
Dreifuss et al[84], 2017	United States	Autologous	Pedal atrophy	Injection	/	12 months	23	Dermal thickness increased significantly post-injection, persisting through 24 months (P < 0.05)
Kress et al[85], 2023	United States	Autologous	Ulcer	Injection	13.9 mL of fat	9.3 months	10	Achieved full clinical recovery with no reulceration
Carstens et al[53], 2021	United States	Autologous	Ulcer	Subcutaneous injection	3 × 107 cells	12 months	63	At 6 months, 51 subjects achieved complete closure, and 8 had closure of ≥ 75%
Nilforoushzadeh et al[86], 2020	Iran	Autologous	Ulcer	Engineered skin graft	/	21 wk	5	There was a significant increase (P ≤ 0.05) in both skin thickness and vascular bed density
Lonardi et al[87], 2019	Italy	Autologous	Minor amputations	Injection	10-30 mL of fat	6 months	114	At 6 months, 80% of the feet showed healing (P = 0.0064)
Carstens et al[42], 2017	United States	Autologous	Ischemia	Intramuscular injection	/	12 months	10	All patients showed clinical improvement (rest pain, claudication, ABI)
Zollino et al[88], 2019	Italy	Autologous	Ulcer	Injection	15 mL of fat	24 wk	16	The average wound healing time was 17.5 ± 7.0 wk (P < 0.036)
Raposio et al[43], 2018	Italy	Autologous	Ischemia	Subcutaneous injection	5 × 105 cells	6 months	7	After 6 months, all patients demonstrated complete wound healing
Namgoong et al[89], 2010	Korea	Autologous	Ulcer	Hydrogel	30-50 mL of fat	16 wk	20	Eight 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], 2010	Korea	Autologous	Ulcer	Subcutaneous injection	4.0-8.0 × 106 cells	8 wk	54	100% healing was achieved
Smith et al[91], 2020	United Kingdom	Autologous	Ulcer	Injection	2 mL of fat/cm²	21 months	18	There was no difference between any of the groups in terms of clinical outcomes
Gennai et al[92], 2021	Italy	Autologous	Minor amputations	Injection	10-30 mL of fat	6 months	114	The average hospital length of stay was 16.2 d (P = 0.025)

ABI: Ankle/brachial index.