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Table 1 Published Clinical Trials

From: Adipose-derived stem cells for treatment of chronic ulcers: current status

Author, year, and country Title Cause of ulcers Patients Randomization and blinding Type of ADSC Application method Primary endpoint Follow-up Conclusion
Han et al. [28], 2010,
The treatment of diabetic foot ulcers with uncultured, processed lipoaspirate cells: a pilot study Peripheral artery disease (diabetes 100%) 28 cases
26 controls
Total 54
Yes, open label Adipose-derived stem cell (ADSC) pellet isolated using collagenase and centrifugation.
Donor site: abdomen
4.0 × 106 to 8.0 × 106 cells
Same-day procedure. Dispersed onto the wound and sealed with fibrinogen, thrombin, and Tegaderm Wound closure rate 2 months 100% of wounds healed in 8 weeks in the case group, 62% in the control group.
No adverse events
Lee et al. [29], 2012,
Safety and effect of adipose tissue-derived stem cell
implantation in patients with critical limb ischemia: a pilot study
Peripheral artery disease.
Thromboangiitis obliterans (80%) and diabetes (20%). 80% with chronic wounds
15 cases
0 controls
Total 15
No, open label Digested using collagenase and centrifugation. Cultured.
Donor site: abdomen
3.0 × 108 cells.
60 intramuscular injections under spinal anesthesia. Time from harvest to injection not mentioned in study Absence of adverse events. Formation of collateral networks. Secondary endpoint: pain, amputation, healing of wounds 6 months Chronic wounds healed in 66.7% of patients. At 6 months, improvement in pain rating and in claudication walking distance. Five patients required minor amputation during follow-up, and all amputation sites healed completely.
No adverse events
Marino et al. [30], 2013 Italy Therapy with autologous adipose-derived regenerative cells for the care of chronic ulcer of lower limbs in patients with peripheral arterial disease Peripheral artery disease 10 cases
10 controls
Total 20
No, open label Freshly isolated using Celution® 800/CRS.
Donor site: abdomen/inner thigh.
260 g lipoaspirate
1.5 × 106 cells
Same-day procedure. 5 mL injected in 1 cm deep injections around the ulcer under peripheral block of the sciatic nerve using a 10-mL syringe and 21-gauge needle Complete healing of the ulcer 3 months Reduction in size, depth, and pain of all cases compared with controls. 6 of 10 cases had total healing, none in control group.
No adverse events
Bura et al. [31], 2014
Phase I trial: the use of autologous cultured adipose-derived stroma/stem cells to treat patients with non-revascularizable critical limb ischemia Peripheral artery disease 7 cases
0 controls
Total 7
No, open label Isolated using collagenase, centrifugation and then cultured.
Donor site: abdomen.
(30 g) 60 mL lipoaspirate 108 cells
14 days after liposuction. 26 mL injected in 30 intramuscular injections (15 in each muscle) into the internal and external gastrocnemius and anterior compartment of the ischemic leg using a 23-gauge needle Improvement of wound healing 6 months Ulcer size, ulcer number, and pain reduced. Improved transcutaneous saturation.
No adverse events
Raposio et al. [32], 2016
Adipose-derived stem cells added to platelet-rich plasma for chronic skin ulcer therapy Venous (45%), ischemic (42%), diabetic (10%) and post-traumatic (3%) 16 cases
24 controls
Total 40
Yes, open label e-PRP from 42 cm3 of peripheral blood combined with ADSC from 80 mL of abdominal fat vibrated at 600 vibrations/min for 6 min and centrifuged at 52 g for 6 min.
5 × 105 cells
Same-day procedure.
5 mL injected in multiple injections around and under the ulcer using a 10-mL syringe
Wound closure rate 18 months Similar healing rates. Wound closure rates higher in case group.
No adverse events
Carstens et al. [33], 2017,
Non-reconstructable peripheral vascular disease of the lower extremity in ten patients treated with adipose-derived stromal vascular fraction cells Peripheral artery disease (3 diabetes, 4 atherosclerosis, and 3 both) 10 cases
0 controls
Total 10
No, open label Fresh, non-fractioned, non-cultured. Enzymatic congestion using collagenase and centrifugation.
Donor site: abdomen 250–350 cm3 fat.
19.1 to 157.8 × 106 cells
3–4 mL administered using a 26-gauge needle into the plane between the gastrocnemius and soleus muscles in a pattern of injections (22 per muscle, 11 in the external and 11 in the internal gastrocnemius, each one 1.5 cm to 2 cm apart) of equal volume each (0.5 ml), on either side of the midline Wound closure rate, pain 18 months 4 of 6 wounds closed within 9 months, one patient had a healing wound when she died at 4 months and 1 patient had a skin graft to close the wound at 5 months. Reduced pain in all patients.
No adverse events
Chopinaud et al. [34], 2017
Autologous adipose tissue graft to treat hypertensive leg ulcer: a pilot study Hypertensive 10 cases
0 controls
Total 10
No, open label LipoStructure®. Freshly purified fat using centrifugation at 3000 rpm for 3 min. Same-day procedure. Multiple injections around and under the ulcer with 0.8-mm cannula Wound closure rate 6 months 73.2% median closure rate at 3 months, 93.1% at 6 months. Reduced fibrin, necrosis and pain. Increased granulation. No adverse events
Konstantinow et al. [35], 2017
Therapy of ulcus cruris of venous and mixed venous arterial origin with autologous, adult, native progenitor cells from subcutaneous adipose tissue: a prospective clinical pilot study Arterial-venous (9 patients), venous (7 patients).
6 patients with diabetes
16 cases
0 controls
Total 16
No, open label The Transpose RT™ Processing Unit (TPU) (InGeneron Inc., Houston, TX, USA) 30 mL lipoaspirate.
Donor site: abdomen.
9–15 × 106 cells
Same-day procedure.
4 ml injected 5 to 10 mm deep into the central and bordering ulcer area using a 1-mL Luer-Lock syringe and a 24-gauge needle. Additionally, 2.5 mL applied on a collagen sponge onto the wound
Wound closure rate, pain 6 months All venous patients and four of nine arterial-venous patients had 100% wound closure within 9–26 weeks.
Reduced wound pain in all patients within days of treatment.
No adverse events
Darinskas et al. [36], 2017
Stromal vascular fraction cells for the treatment of critical limb ischemia: a pilot study Peripheral artery disease
(7 patients with ulcers)
(9 patients with diabetes)
15 cases
0 controls
Total 15
No, open label Uncultured ADSC isolated without collagenase using mechanical isolation (the fat minced using a metal mill and subsequent centrifugation) 40 mL lipoaspirate
Donor site: abdomen
One or two 20-mL syringes with minimum of 20 million viable cells per syringe and a minimum of 30 injections per syringe. Intramuscular injections along the arteries.
Secondary injections were performed 2 months after first application of cells
Wound closure rate, pain 12 months All ulcers healed. Two patients had amputations.
Reduced pain in all patients.
86.7% with improvement in walking distance.
No adverse events