Cell Therapy for Peripheral Arterial Disease and Diabetes
Condition: Peripheral Arterial Disease; Diabetes Mellitus
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Diabetes Mellitus
Study type: Interventional

Summary: 
      This is a randomized controlled trial with blinding (for the observer who evaluates treatment
      goals).

      With two groups to study. A group of patients with conventional therapy for the treatment of
      PAD (Platelet antiaggregant, statin, cilostazol in case of claudication) and the other group
      of patients with conventional therapy for treatment of PAD plus cell therapy with objective
      to evaluate the microvascular effect after the application of cell therapy with a
      hematopoietic stem cell concentrate in patients with PAD with non-critical ischemia and
      Diabetes. Perform evaluations of the microcirculation by means of TcPO2 at 30, 60, 90 and 180
      days after the experimental maneuver (cell therapy) and conventional therapy.
    

Detailed description: 
      INTRODUCTION: Peripheral arterial disease (PAD) is defined as arterial occlusion of the lower
      extremities. Based on epidemiological studies using the Ankle-Brachial Index (ABI), the
      prevalence of PAD (defined as an ABI <0.9) in diabetic patients ranges from 20% to 30%.
      Diabetic patients with PAD have a higher mortality and death rate at a younger age than
      patients without diabetes. The appropriate medical treatment for EAP in patients with
      diabetes is based on the control of cardiovascular risk factors. Revascularization is
      indicated in particular situations in PAD in the context of critical chronic ischemia (ABI
      <0.6), however, anatomical factors, operative risk, technical difficulties or patient
      preferences may limit its use in patients with PAD and diabetes. Therapeutic angiogenesis is
      an experimental approach to restore perfusion and cell therapy can provide a continuous
      source of growth factors and structural elements for therapeutic angiogenesis. The
      transcutaneous oxygen pressure (TcPO2) is defined as a microvascular evaluation system. The
      microvascular effect of cell therapy at an earlier stage of PAD has not been analyzed as
      non-critical ischemia in patients with diabetes.

      OBJECTIVE: To evaluate the microvascular effect after the application of cell therapy with a
      concentrate of hematopoietic stem cell in patients with PAD with non-critical ischemia and
      Diabetes.

      MATERIAL AND METHODS: Randomized controlled clinical trial with blinding (for the observer
      who evaluates treatment goals). With two groups for your study. A group of patients with
      conventional therapy for the treatment of PAD (Platelet antiaggregant, statin, cilostazol in
      case of claudication) and the other group of patients with conventional therapy for treatment
      of PAD plus cell therapy, to be carried out in patients entitled to the Mexican Institute of
      the Social Security of the Guanajuato Delegation, with diagnosis of Diabetes Mellitus type 2
      of more than 10 years of detection and with diagnosis of peripheral arterial disease with an
      ABI between 0.6 and 0.9 that agree to participate in the study. Cell therapy will consist of
      hematopoietic progenitor cells identified as a fraction of cells identified by flow cytometry
      as CD34 + obtained by peripheral blood harvesting procedure, prior mobilization process with
      filgrastim.
    

Intervention name(s): celular therapy
Intervention type(s): Procedure
Intervention description(s): application of cell therapy with a concentrate of hematopoietic progenitor cells or celular therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Treatment for peripheral arterial disease plus diabetes with 2 arms of study.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment