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NCT Number: NCT05154591

CKDu Treated With Intra-arterial Infusion of Autologous SVF Cells

This is an interventional study to treat 18 patients with chronic kidney disease of unknown cause (CKDu), formerly known as Mesoamerican nephropathy (MeN), with autologous adipose tissue-derived stromal vascular fraction (SVF) cells transplanted by intra-arterial injection both kidneys.

This study assesses: (1) safety and tolerability, (2) preliminary evidence of efficacy, (3) exploratory evidence of clinical effects.

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Key information

About this study

Patients under go 24 hours of preoperative hydration combined with N-actyl cysteine 300 mg IV for prevention of nephrotoxicity. Under general anesthesia 200-300 cc of lipoaspirate is collected into a sterile processing cannister (GID SFV-1, Louisville, CO, USA). The tissue is washed and dissociated with collagenase (Worthington CLS-1, Lakewood, NJ, USA) at a concentration of 200 CDU/ml of total volume for 50 minutes at 39°C. This is followed by inactivation using 40 cc of human serum albumin. SVF cells are separated via centrifugation for 10 minutes at 800 g. The cell pellet is extracted and resuspended in Harmann solution with an aliquot (10 µl) removed for counting and viability assessment of resulting total nucleated cells (YNC) through and image cytometer (ADAM MC, Portsmouth NH, USA).

Femoral artery catheterization is performed permitting advancement of a 100 cc balloon-tip catheter into the renal artery under fluoroscopic control, with position confirmation using 1 cc of OrtoRay® 320 contrast diluted 1:4 with Hartmann solution. SVF cells are then admixed with 200 cc Hartmann solution warmed to 37°C and in fused using a DRE infusion pump (DRE Medical, Louisville, KY, USA) over a 15 minute period with constant agitation. On the 1st pos-operative day creatinine and glomerular filtration rate are checked and the patient is discharged.

Follow-up studies include clinical assessment, chemistries, and renal ultrasound to assess intra-parenchymal renal volume, renal blood flow distribution, and hilar artery vascular resistance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Mesoamerican nephropathy
  • Stages 3 and 4
  • No other renal disease
  • No essential hypertension

Exclusion criteria

  • Significant abnormalities in laboratory tests that contraindicate surgical procedures.
  • Acute pathology or complications of significant chronic pathologies in the 6 months prior to study entry, including, but not limited to:

Medical history of deep vein thrombosis Uncontrolled hypertension Active infection Reduced cardiac ejection fraction Hepatitis B, C or HIV Diabetes treated with insulin or glucose lowering agents Anemia (Hb <9 g/dL) History of cancer Severe depression (Beck scale) Autoimmune disease

Treatment and study plan

Adipose-derived stromal vascular fraction cells

Genetic

Kidney structural and functional changes in 18 patients after 36 months of treatment with SVF cells.

Primary outcomes

  1. Incidence of treatment related adverse events

    Time frame: 36-months follow-up post intervention.

    Documentation of adverse events

  2. Preliminary evidence of efficacy

    Time frame: Assessment of changes between day 7 and month 36 post intervention.

    Improvement in clinical parameter of GFR as compared with historical age and stage-matched controls.

Secondary outcomes

  1. Renal blood flow.

    Time frame: Up to month 12 post intervention.

    Distribution of intra-renal blood flow.

  2. Kidney volume.

    Time frame: Up to month 12 post intervention.

    Changes in kidney size (cm3).

  3. Renal arterial resistive index.

    Time frame: Up to month 12 post intervention.

    Decreases in hilar artery resistance index (less o equal to 0.7).

Sponsors and collaborators

Lead sponsor

Samuel Vilchez, PhD

Other

Collaborators

  • GID BIO
  • Ministerio de Salud de Nicaragua
  • National Autonomous University of Nicaragua

Registry information

Official study title

Chronic Kidney Disease of Unknown Cause (CKDu) Treated With Directed Local Intra-arterial Infusion of Autologous Stromal Vascular Fraction (SVF) Cells.

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 13, 2021
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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