SVF
Level B· Emerging Clinical EvidenceRandomized Controlled Trial

Clinical efficacy and safety of allogeneic adipose-derived stem cells ELIXCYTE in chronic kidney disease: a phase I/II study.

Lin YC., Hung YP., Tian YC., Wu MJ., Lin HC., Chen SY.

Randomized Controlled Trial on Chronic Kidney Disease, published in Stem Cells Transl Med (2026) — summary generated from the PubMed abstract.

This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.

Study type
Randomized Controlled Trial
Journal
Stem Cells Transl Med (2026)
Country
England
Reported sample size
—
PMID
41555517
DOI
10.1093/stcltm/szaf076

Abstract (original English)

Chronic kidney disease (CKD) poses a significant global health burden by reducing quality of life and increasing mortality. Current therapies remain inadequate in halting its progression, necessitating novel treatments to improve outcomes. Adipose-derived stem cells (ADSCs) have emerged as a promising therapeutic option. Phase I/II clinical trials evaluated the efficacy, safety, and tolerability of ELIXCYTE in slowing CKD progression. This multicenter, randomized, open-label study monitored estimated glomerular filtration rate (eGFR) changes over a 48-week period following a single intravenous infusion of ADSCs. Participants were allocated to one of three dosage groups, with primary outcomes assessing eGFR changes and secondary outcomes focusing on safety and tolerability. Results confirmed a favorable safety profile, with no dose-limiting toxicities observed in the low- and moderate-dose groups. Group-based trajectory modeling (GBTM) indicated that, overall, 88.24% of patients exhibited a trend of improvement or stabilization. In the low-dose group, 72.23% of patients demonstrated a stable trend, which was more consistent than in other dosage groups. Furthermore, patients with CKD stage 3B showed a numerically higher proportion of improving trajectories compared to those with stage 4 disease. The low-dose ADSC group exhibited a trend toward more favorable renal function trajec

What this study does not prove

  • • This study does not prove SVF is an approved treatment or a replacement for standard care.

Evidence level

Several human studies exist, but sample sizes, methodology, or follow-up remain limited, so conclusions are not firm.

How we grade evidence
HumansMaleFemaleMiddle AgedRenal Insufficiency, ChronicAdipose TissueAgedGlomerular Filtration RateAdultTreatment Outcome
Systemic / IVChronic Kidney Disease
View on PubMedDOI

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