Clinical Trial: Stem Cell Therapy for Patients With Focal Segmental Glomerulosclerosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Safety Study of the Endovascular Infusion of Bone Marrow Derived Mononuclear Cells in Patients With Focal Segmental Glomerulosclerosis

Brief 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 Summary:

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
Sponsor: Universidade Federal do Rio de Janeiro

Current Primary Outcome:

  • Kidney injury [ Time Frame: 9 months ]

    Increase of serum creatinine of about 0.5 mg / dL when levels are less than 3.0 mg / dl and 1.0 mg / dl baseline levels when are greater than or equal to 3.0 mg / dL) when confirmed with the second examination.

    • Acute: evaluated within 15 days of cell therapy;
    • Subacute: evaluated 15-90 days of cell therapy
  • Chronic kidney disease [ Time Frame: 9 months ]
    Doubling of serum creatinine based on the third month after the cell therapy or the need to start dialysis
  • Potential differentiation disorders of transplanted cells [ Time Frame: 9 months ]
    Analyzed by clinical and imaging tests such abdominal ultrasound and chest radiography
  • Systemic inflammatory potential of mononuclear cells administration in renal circulation [ Time Frame: 9 months ]
    Laboratory tests: C-reactive protein, erythrocyte sedimentation rate, blood count and urinary sediment
  • Death [ Time Frame: 9 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Renal function [ Time Frame: 9 months ]
    The estimated creatinine clearance assessment by MDRD formula
  • Bone metabolism [ Time Frame: 9 months ]
    Evaluation of bone metabolism by serum phosphorus (mg/dL), calcium (mg/dL), parathormone (pg/ml), 25 (OH) vit. D (ng/ml).
  • Balance assessment electrolyte and acid-base [ Time Frame: 9 months ]
    Balance assessment electrolyte and acid-base by serum sodium (mEq/l), potassium (mEq/l), uric acid (mg/dl) and bicarbonate
  • The lipid profile assessment and anemia [ Time Frame: 9 months ]
    The lipid profile assessment (LDL- cholesterol, HDL-cholesterol and triglyceride) and anemia measured by hemoglobin (g/dL) and hematocrit.
  • Quality of life questionnaire [ Time Frame: 9 months ]
    Clinical improvement of the patient, with subjective assessment of general health and well being through SF36 quality of life questionnaire
  • Imaging tests [ Time Frame: 9 months ]
    Imaging tests: Renal scintigraphy with 99mTc-DTPA and DMSA


Original Secondary Outcome: Same as current

Information By: Universidade Federal do Rio de Janeiro

Dates:
Date Received: January 30, 2016
Date Started: June 2015
Date Completion: June 2017
Last Updated: August 28, 2016
Last Verified: August 2016