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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