Level C· Early Human Research
Safety of Stromal Vascular Fraction Cell Therapy for Chronic Kidney Disease of Unknown Cause (Mesoamerican Nephropathy)
Carstens M.H., García N., Mandayam S., Correa D.
First-in-human safety study: 18 patients with stage 3–5 CKDu received SVF via bilateral renal artery catheterization and were followed for 36 months.
- Study type
- Clinical Trial
- Journal
- Stem Cells Translational Medicine (2023)
- Country
- Nicaragua / United States
- Sample size
- 18
- Follow-up
- 36 months
- PMID
- 36545894
- DOI
- 10.1093/stcltm/szac080
What was studied
Safety and tolerability of intra-renal-artery SVF infusion in chronic kidney disease.
Methods
- • Open-label single infusion into both kidneys, assessed with color Doppler and eGFR.
Key findings
- • No SVF-related serious adverse events and no procedural complications.
- • At two months, perfusion increased in every kidney evaluated (36/36).
- • Patients with baseline eGFR ≥30 sustained function, while those <30 continued to decline after 12 months.
Limitations
- • Very small sample with no control group.
- • Designed to assess safety, not efficacy.
What this study does not prove
- • Does not prove SVF slows kidney deterioration.
- • This study does not prove SVF is an approved treatment or a replacement for standard care.
- • Limited follow-up cannot indicate long-term outcomes.
Clinical interpretation
Rare 36-month safety data and a preliminary signal that warrants randomized testing.
Evidence level: Early Human Research