SVF
Level D· Preclinical EvidenceLaboratory Study

Preclinical safety and efficacy of an allogeneic adipose-derived mesenchymal stem cell medicinal product for rotator cuff repair: a two-phase experimental study.

Lopiz Y., Ponz-Lueza V., Arvinius C., Rodríguez-Bobada C., Rojo-Pérez F., Tornero-Esteban P.

Laboratory Study with a reported sample of 24 on Tendon Injury, Rotator Cuff, published in J Shoulder Elbow Surg (2026) — summary generated from the PubMed abstract.

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Study type
Laboratory Study
Journal
J Shoulder Elbow Surg (2026)
Country
United States
Reported sample size
24
PMID
42297179
DOI
10.1016/j.jse.2026.06.005

Abstract (original English)

Cell therapy with adipose-derived mesenchymal stem cells (ASCs) is a promising biological augmentation strategy for rotator cuff repair; however, before clinical translation, regulatory frameworks mandate rigorous preclinical characterization of safety. We report the complete preclinical program evaluating both the safety of an allogeneic ASC-based cell therapy medicinal product (CTMP) and its efficacy in a chronic rotator cuff tear model. Phase I (safety, 164 immunodeficient nude BALB/c mice) assessed toxicity, biodistribution, and tumorigenicity after intra-articular and intravenous administration at doses ranging from 10× to 1,000× the projected clinical dose. Toxicity was evaluated by biochemical panels and full-body histopathology at 90 days. Biodistribution was quantified by fluorodeoxyglucose-positron emission tomography/computed tomography (days 45 and 90) and human-specific quantitative polymerase chain reaction (Alu-repeat) at 90 days. Tumorigenicity used an HT-29 positive-control model. Phase II (efficacy, 48 Sprague-Dawley rats) used a validated 4-week chronic supraspinatus tear-and-repair model; after repair, animals received ASCs in suspension (n = 24) or Hypothermosol vehicle (n = 24) and were assessed histologically (Åström-Rausing scale) and biomechanically (Instron 4,411) at 4 months. In Phase I, no biochemical or histopathological toxicity attributable to the

What this study does not prove

  • • This study does not prove SVF is an approved treatment or a replacement for standard care.
  • • This is preclinical work; animal or laboratory results cannot be applied to humans.

Evidence level

Evidence comes from animal or laboratory studies and has not been confirmed in humans.

How we grade evidence
ShoulderSystemic / IVTendon InjuryRotator Cuff
View on PubMedDOI

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