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

SVF2015MeN-1

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.

2018-01-01

2021-02-28

2021-02-28

Completed

Early phase I

18

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '* Open label for surgeons and radiologists\n* Closed label for pathologists and nephrologists'}}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}

2023-11-13