SVF
Level B· Emerging Clinical EvidenceClinical Trial

Allogeneic adipose tissue-derived stem cells ELIXCYTE ® in chronic kidney disease: A phase I study assessing safety and clinical feasibility.

Zheng CM., Chiu IJ., Chen YW., Hsu YH., Hung LY., Wu MY.

Clinical Trial with a reported sample of 12 on Chronic Kidney Disease, published in J Cell Mol Med (2022) — 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
Clinical Trial
Journal
J Cell Mol Med (2022)
Country
England
Reported sample size
12
PMID
35415928
DOI
10.1111/jcmm.17310
NCT
NCT02933827

Abstract (original English)

The purpose of this phase I clinical trial is to assess the safety and tolerability of allogeneic adipose tissue-derived stem cells (ADSCs) among chronic kidney disease (CKD) patients. 12 eligible CKD patients with an estimated glomerular filtration rate (eGFR) of 15-44 ml/min/1.73 m 2 received one dose of intravenous allogeneic ADSCs (ELIXCYTE ® ), as 3 groups: 3 low dose (6.4 × 10 7 cells in total of 8 ml), 3 middle dose (19.2 × 10 7 cells in total of 24 ml) and 6 high dose (32.0 × 10 7 cells in total of 40 ml) of ELIXCYTE ® and evaluated after 48 weeks. Primary endpoint was the safety profiles in terms of incidence of adverse events (AEs) and serious adverse event (SAE). Two subjects in high dose group experienced a total of 2 treatment-related AEs which are Grade 1 slow speech and Grade 1 bradyphrenia after the infusion. One subject in middle dose group experienced an SAE unlikely related to treatment, grade 2 proteinuria. No fatal AE was reported in this study. An increase in eGFR was observed in 7 out of 12 subjects (58%) at Week 24 and in 6 of 12 subjects (50%) by Week 48. By Week 24, an increase in eGFR by more than 20% among all CKD patients with baseline eGFR ≧ 30 ml/min/1.73 m 2 as compared to only 2 subjects in baseline eGFR < 30 ml/min/1.73 m 2 group. No significant reduction in proteinuria was noted among all subjects. This phase I trial demonstrated single-dose i

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
Adipose TissueFeasibility StudiesFemaleHematopoietic Stem Cell TransplantationHumansMaleRenal Insufficiency, ChronicTreatment Outcome
Systemic / IVChronic Kidney Disease
View on PubMedDOI

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