Preclinical and early clinical safety of intra-articular spheroid adipose-derived stem cells for knee osteoarthritis: A translational 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

Abstract (original English)

Objective To evaluate preclinical and early clinical safety of intra-articular spheroid adipose-derived stem cells (S-ADSCs) for knee osteoarthritis and to summarize exploratory outcomes. Methods This program included a minipig study ( n = 3; Day 31) and a clinical cohort ( n = 5; Week 52). Each knee received 42,000 spheroids (500 cells/spheroid; 2.1 × 10 7 cells) in 5 mL. Preclinical assessments included clinical monitoring, laboratory tests, necropsy, and H&E histology of distal femur, proximal tibia, and medial/lateral menisci. In patients, adverse events and serious adverse events were captured through Week 52; exploratory outcomes included pain (visual analog scale [VAS]) and function (KOOS and WOMAC). Exploratory quadratic mixed-effects models assessed non-linear time trends. Results Minipigs showed no abnormal clinical signs, laboratory changes, or treatment-related findings at necropsy or on knee histology through Day 31. All five patients completed 52-week follow-up; no treatment-related adverse events or serious adverse events, infections, hemarthroses, or acute post-injection flares requiring medical treatment occurred. Exploratory outcomes were heterogeneous: two participants showed sustained improvement through Week 52, whereas the remaining three showed non-sustained patterns; two improved early with partial return toward baseline, and one experienced transient pa

Evidence level

Early human evidence such as case series or small samples is exploring possible benefits.

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