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Table 3 Overview of randomized clinical studies on bone-marrow-derived stem cell treatment of diabetic foot ulcers published within the last ten years

From: Novel topical allogeneic bone-marrow-derived mesenchymal stem cell treatment of hard-to-heal diabetic foot ulcers: a proof of concept study

Author Method Participants Formulationa Method of delivery Outcomes
Debin et al. [17] Patients randomized to BMMSC or standard care 38 Autologous BMMSC Intramuscular and intralesional injections Increased complete ulcer healing rates in treatment group
Increased ABI in treatment group
Decreased amputation rates
Dash et al. [18] Patients randomized to BMMSC or standard care 6 Donor BMMSC Intramuscular injections, intralesional injections and topical application Increased ulcer healing rates
Prochazka et al. [23] Patients randomized to BMMSC or standard care 96 Autologous BMMSC Intramuscular injections Decreased amputation rates in treatment group
Lu et al. [21] Patients randomized to BMMSC or BMMNC in one limb and saline in the other limb 41 Autologous BMMSC
Autologous BBMNC
Intramuscular and intralesional injections Increased complete ulcer healing BMMSC > BMMNC > NS
Decreased amputation rates BMMSC > BMMNC > NS
Jain et al. [19] Patients randomized to BMMSC or whole Blood 48 Autologous BMMSC Intralesional injection and topical application Increased complete ulcer healing in treatment groupb
Kirana et al. [20] Patients randomized to BMMSC or BMMNC in both limbs 22 Autologous BBMSC
Autologous BBMNC
Intramuscular injection
or
Intraarterial injection
Improved TcPO2 from baseline in both groups
No significant difference in ulcer healing
Lu et al. [22]c Patients randomized to BMMSC or BMMNC in one limb and saline in the other limb 41 Autologous BMMSC
Autologous BBMNC
Intramuscular and intralesional injections Decreased incidence of ulcer recurrence for BMMSC (vs. NS)
No significant difference in amputation rates
  1. BMMSC, bone marrow mesenchymal stem cells; ABI, ankle-brachial-index; BMMNC, bone marrow-derived mononuclear cells; NS, normal saline; TcPO2, transcutaneous partial pressure of oxygen
  2. aRefers to the applied cell types. However, the preparation and suspension of cells differed from study to study
  3. bComplete ulcer healing was defined as both healed by secondary intention and treated with skin graft
  4. cFollow-up study on patients from 2011 study by Lu et al