Patients in the severe stages of Chronic limb-threatening ischemia (CLTI) are prone to amputation and death, leading to poor quality of life and a great socioeconomic burden. There is an urgent need to develop an effective therapeutic strategy to treat this disease. In this context, autologous bone marrow mononuclear cells (BM-MNC) and allogeneic mesenchymal stem cells derived from different sources have emerged as promising therapeutic approaches for this condition.
Comparison of the therapeutic potential of BM-MNC vs. allogeneic Wharton jelly-derived mesenchymal stem cells (allo-WJ-MSCs) in diabetic patients with CLTI. Twenty-four type 2 diabetic patients in the most severe stages of the CLTI (category 4 or 5 in Rutherford's classification and transcutaneous oxygen pressure (TcPO2) below 30 mm Hg were enrolled and randomized to receive 15 injections of (i) BM-MNC (7.197x106 ± 2.984 x106 cells/mL each with 2% of autologous serum) (n=7), (ii) allo-WJ-MSCs (1.333 x106 cells/mL each with 5% of human serum albumin serum) (n=7) or (iii) placebo solution (1 mL saline solution with 2% of autologous serum) (n=10), which were administered into the periadventitial arteries. The follow-up visits were at months 1, 3, 6, and 12, to evaluate the following parameters: (i) Rutherford classification (0 to 6) (ii) TcPO2 (mmHg) (iii) Wound closure (area cm2) (iv) pain (visual analogue scale (0-10) (v) pain-free walking distance (m) (vi) revascularization and limb-survival proportion during follow-up (vii) the quality of life (EQ-5D questionnaire).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
One dose of auto-BM-MNC, one dose of allo-WJ-MSCs, or one dose of placebo solution (saline solution with 2% of autologous serum), were periadventitial arteries administration in CTLI patients.
Fundación Oftalmológica de Santander (FOSCAL)
Bucaramanga, Colombia
Safety profile: (adverse events (AEs) and serious AEs)
AEs: (i) local toxicity, including signs of local inflammation (swelling, warmth, impairment of function), worsening of ulcer, new ulcer, or hematomas after auto-BM-MNC or allo-WJ-MSCs administration. (ii) systemic toxicity as fever, allergies. (iii) maximum grade toxicity for tissue.
Time frame: 12 months
Safety profile
Serious AEs: hospitalization, malignancy, amputation, persistent or significant disability, or death.
Time frame: 12 months
Efficacy profile: Rutherford's classification
0 to 6
Time frame: 12 months
TcPO2
mmHg
Time frame: 12 months
Efficacy profile: Visual Analogue Scale pain
0 to10
Time frame: 12 months
Efficacy profile: Pain-free walking distance
meters
Time frame: 12 months
Efficacy profile: Wound closure
cm2
Time frame: 12 months
Efficacy profile: Revascularization
Percentage
Time frame: 12 months
Efficacy profile: Limb survival proportion
Percentage
Time frame: 12 months
Efficacy profile: Quality of life
EQ-5D questionnaire
Time frame: 12 months
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