Application of Cell Regeneration Therapy With Mesenchymal Stem Cells From Adipose Tissue in Critical Chronic Ischemic Syndrome of Lower Limbs (CLI) in Nondiabetic Patients.
Condition: Critical Limb Ischemia
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Clinical trial phase I / II, prospective, multicenter, open, randomized, parallel-groups
      controlled by two levels of dose to assess the safety and feasibility of the infusion of
      mesenchymal stem cells from adipose tissue administered intra-arterially in nondiabetic
      patients with chronic ischemia of lower limbs (CLI) and no possibility of revascularization.
    

Detailed description: 
      A prospective, multicenter, open, randomized, parallel-group controlled study for two levels
      of dose.

      The study population will consist of 30 non-diabetic patients with critical chronic ischemia
      in at least one of the lower limbs (CLI) and without possibility of revascularization, from
      whom results can clinically be evaluable, of whom, 20 patients will be included in the
      experimental group (10 for each dose level) and 10 in the control group.

      In each of the two dose levels to be used in the study, 15 patients will be included, who
      will be randomized to the experimental group or the control group according to a distribution
      2:1 (2 patients in the experimental group and 1 in control group), thus at each dose level,
      we will have 10 patients in the experimental group (treated with mesenchymal cells of adipose
      tissue) and 5 patients in the control group (conventional treatment, including the use of
      prostaglandins per protocol).

      Patients who are randomized to experimental treatment Group with CeTMAd may receive one of
      the following dose levels:

        -  0.5x106 cells / kg of patient weight

        -  1x106 cells / kg of patient weight

      The recruitment will be done with escalating doses, starting at the lower dose. To switch to
      the higher dose will require a favorable opinion of the Ethics Committee of the H.
      Universitario Virgen Macarena to evaluate the clinical status of patients and therapeutic
      safety and study procedures.

      Patients who are randomized to the treatment control group will continue with conventional
      treatment which they were performing at the time of inclusion in the study (including the use
      of prostaglandins as protocol).

      STUDY OBJECTIVE: To evaluate the safety and feasibility of regenerative treatment with
      mesenchymal stem cells from adipose tissue (CeTMAd), administered intraarterial in
      nondiabetic patients with chronic critical ischemia of at least one lower limb without
      possibilities of revascularization or alternative therapies. We will analyze the
      complications from regenerative therapy and / or study procedures.

        -  Main objectives:

             1. Security: It will be studied the possible complications due to the procedure in the
                first 24 hours of administration of CeTMAd, 1 month, 3 months, 6 months, 9 months
                and 12 months.

             2. Efficiency: It will be studied the generation of new vessels (vasculogenesis) and
                enhancement of collateral circulation (angiogenesis / arteriogenesis).

        -  Secondary objectives:

      It will be studied the evolution of ankle brachial index, transcutaneous oxygen pressure,
      degree of Rutherford-Becker, ulcer size, calf perimeter, the score of pain and intermittent
      claudication (walking test).

      Duration of the clinical trial: From the infusion to the patient of the Mesenchymal Stem
      Cells from Adipose Tissue to the end of the monitoring, there will be 12 months.
    

Intervention name(s): Mesenchymal stem cells from adipose tissue
Intervention type(s): Other
Intervention description(s): - Infusion of mesenchymal stem cells from adipose tissue administered intraarterially: 0.5x106 cells / kg of patient weight and 1x106 cells / kg of patient weight.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment