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MSCS FOR CHRONIC WOUND TREATMENTS 561

Table 3. (Continued)
Study Condition Status Phase NCT number
Autologous bone marrow stem cell transplantation DFU Unknown 2/3 NCT00434616
for critical, limb-threatening ischemia
Safety and efficacy of autologous bone marrow DFU; leg ulcer Active, not recruiting 1/2 NCT01903044
stem cells for lower extremity ischemia treating
Adipose-derived regenerative cellular therapy of DFU; venous Unknown 2 NCT02092870
chronic wounds ulcer
Cell therapy for venous leg ulcers pilot study Venous leg ulcer Completed 1 NCT01750749
Allogeneic ABCB5-positive stem cells for Venous leg ulcer Recruiting 1/2 NCT03257098
treatment of CVU
Autologous bone marrow stem cells for chronic leg Leg ulcer Unknown 1 NCT02619734
ulcer treatment in sickle cell disease
Healing chronic venous stasis wounds with Chronic venous Active, not recruiting NA NCT02961699
autologous cell therapy stasis ulcer
Allogeneic ABCB5-positive stem cells for Peripheral arterial Recruiting 1/2 NCT03339973
treatment of PAOD occlusive ulcer
Clinical trial to investigate efficacy and safety of Skin ulcer Recruiting 1/2 NCT02742844
the IMP in patients with nonhealing wounds
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originating from ulcers
UC-MSCs gel treatment difficult healing of skin Skin ulcer Completed 1 NCT02685722
ulcers
Therapeutic potential of stem cell conditioned Chronic ulcer NYR 1 NCT04134676
medium on chronic ulcer wounds
Adipose-derived stromal cells and pressure ulcers Pressure ulcer Recruiting 1 NCT02375802
Autologous bone marrow stem cells in pressure Pressure ulcer Completed 1/2 NCT01572376
ulcer treatment
Adipose-derived regenerative cellular therapy of Pressure ulcer Unknown 2 NCT02092870
chronic wounds
ASC, adipose-derived stem cell; DFU, diabetic foot ulcer; MSC, mesenchymal stem cell; NA, not applicable; NYR, not yet recruiting.

sores. In the literature, some clinical studies have reported gradual ulcer healing was observed 3 months after the
the application of MSCs for lower extremity ulcers, radia- transplantation of umbilical cord MSCs. 147
tion burns, and pressure sores (Table 4). Also, in recent years, placenta MSCs have been used in
several case studies. In a phase 1 study, placenta MSCs were
intramuscularly injected into the calves of legs with index
Lower extremity ulcers
ulcers in diabetic patients. Preliminary evidence of ulcer
For lower extremity ulcers, the transplantation of MSCs healing was recorded 3 months posttreatment. 148 In another
has generated promising results in the clinical studies (Ta- case study, placenta MSCs mixed in a sodium alginate gel
ble 4). Bone marrow aspirate was one of the initial attempts were topically applied to a diabetic foot ulcer, which was
to heal lower extremity ulcers. 143 Despite some success in almost healed 3 weeks later, and no wound recurrence oc-
this attempt, the large number of inflammatory cells, to- curred in the subsequent 6 months. 149
gether with the low frequency of stem cells in the bone In addition to case reports, some clinical trials with a
marrow, makes it a less attractive source for cell-based relatively large pool of patients have been reported. 150–153
therapy. Therefore, several groups have explored the wound For instance, Dash et al. performed a randomized study,
healing potential of cultured BM-MSCs. 144,145 According to including 24 patients with nonhealing lower limb ulcers.
the results, BM-MSCs significantly enhanced the healing of After transplantation of autologous cultured BM-MSCs,
lower extremity ulcers. For instance, Falanga et al. reported they found a significant improvement in the reduction of
a strong correlation between the density of BM-MSCs ap- ulcer size. 150 In another randomized clinical study, Lu et al.
plied to the chronic wounds and the reduction of ulcer compared the wound-healing effect of BM-MSCs, bone
size. 145 They found that the greater the number of applied marrow mononuclear cells, and normal saline for the treat-
cells, the larger the reduction in ulcer area. ment of diabetic foot ulcers in 41 patients. 151 A higher
Along with BM-MSCs, other sources of MSCs have been healing rate and a better limb perfusion were recorded in the
utilized. Lafosse et al. developed a biological dressing made BM-MSCs group than in other groups. Similarly, Kirana
of adipose MSCs and human acellular collagen matrix to et al. reported that autologous BM-MSCs significantly im-
treat chronic wounds. After implantation, the dressing sig- proved the wound healing in 18 out of 20 patients with
nificantly improved dermal angiogenesis and wound re- lower limb ulcers. 152
modeling. 146 In 2016, a randomized controlled clinical study More recently, Moon et al. have conducted a randomized,
was conducted by Qin et al. to evaluate the healing effect of comparator-controlled, multicenter study to assess the po-
umbilical cord MSCs for diabetic foot ulcers. Complete or tential of hydrogel-based allogeneic adipose-derived stem