Stem Cell Therapy for Patients With Focal Segmental Glomerulosclerosis
Condition: Focal Segmental Glomerulosclerosis; Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Glomerulosclerosis, Focal Segmental
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to analyze the safety, renal function, metabolic disorders and
      quality of life data in patients with focal segmental glomerulosclerosis treated with
      endovascular infusion of bone marrow derived mononuclear cells.
    

Detailed description: 
      Will be studied five patients with progressive chronic kidney disease and estimated clearance
      between 40 and 20 ml / min. Patients will be followed by clinical and laboratory examination
      for 3 months prior to the procedure. These previous results serve as a control for comparison
      with a second time when the same patients receive treatment with stem cells being
      subsequently followed up for 9 months a total of one year of clinical follow-up.

      Bone marrow aspiration and subsequent cell preparation were accomplished on the same day as
      the endovascular infusion of autologous Bone Marrow derived Mononuclear stem cells (BMDMCs)
      in both renal arteries. Collection was performed under spinal anesthesia and light sedation,
      through puncture and repeated aspirations at the posterior iliac crest region. A total of 80
      mL of bone marrow aspirate was collected from each patient, and after removal of bone and
      fatty residues, mononuclear cells were isolated by a Ficoll-Paque Plus (Amersham Biosciences,
      São Paulo, Brazil).For each patient, 2×107 cells will be labeled with 99mTc. Briefly, 500 μl
      of sterile SnCl2 solution is added to the cells and the mixture is incubated at room
      temperature for 10 min. Forty-five millicurie (mCi) of 99mTc is then added and incubation
      continued for another 10 min. After centrifugation (500×g for 5 min), the supernatant is
      removed and the cells are washed in saline solution. The pellet will be also resuspended in
      saline solution. Viability of the labeled cells will be assessed by the trypan blue exclusion
      test, and estimated to be greater than 93% in all cases.The labeling efficiency (%) will be
      calculated by the activity in the pellet divided by the sum of the radioactivity in the
      pellet plus supernatant and estimated to be greater than 90% in all cases.

      After the collection of the stem cells, the patient will be submitted to puncture the femoral
      artery using the Seldinger technique under local anesthesia, followed by catheterization of
      the ostium of the renal arteries with minimum use of nonionic iodinated contrast. With the
      routing of diagnostic catheter or guide, the solution numbering about 30 to 100 million of
      dissolved plasma cells will be divided and injected into two renal arteries. The infusion
      volume is about 5 ml in each kidney. Whole body and planar scans will be performed 2 and 24h
      after infusion to determine the migration and cell viability. The patient will remain
      hospitalized for more 48 hours for clinical monitoring and collection of laboratorial tests.
    

Intervention name(s): Bone marrow stem cell
Intervention type(s): Other
Intervention description(s): Endovascular infusion of bone marrow derived cells in both renal arteries.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bone marrow cells; Focal Segmental Glomerulosclerosis; Chronic Kidney Diseases; stem cell; cell therapy