CKDu Treated With Intra-arterial Infusion of Autologous SVF Cells

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05154591

Enrollment

Registered

2021-12-13

Start date

2018-01-01

Completion date

2021-02-28

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Failure of Unknown Cause

Keywords

Stromal vascular fraction, Mesenchynmal stem cells, Chronic kidney disease, Adipose stem cells

Brief summary

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.

Detailed description

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.

Interventions

GENETICAdipose-derived stromal vascular fraction cells

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

* Open label for surgeons and radiologists * Closed label for pathologists and nephrologists

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of treatment related adverse events	36-months follow-up post intervention.	Documentation of adverse events
Preliminary evidence of efficacy	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

Measure	Time frame	Description
Renal blood flow.	Up to month 12 post intervention.	Distribution of intra-renal blood flow.
Kidney volume.	Up to month 12 post intervention.	Changes in kidney size (cm3).
Renal arterial resistive index.	Up to month 12 post intervention.	Decreases in hilar artery resistance index (less o equal to 0.7).

Countries

Nicaragua

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026