Level C· Early human research exploring benefits
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.
Level C· Early human research exploring benefitsEvidence level of this study
Early human evidence such as case series or small samples is exploring possible benefits.
- Level A · Stronger Clinical Evidence
- Level B · Emerging clinical evidence with positive signals
- Level C · Early human research exploring benefits
- Level D · Scientific groundwork from lab and animal studies
- Emerging · Emerging topic under active research
- 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 exploring benefits