SVF
Level D· Preclinical EvidenceLaboratory Study

Initial safety outcomes of adipose-derived mesenchymal stem cell for rotator cuff tear: A 3-year pilot trial.

Nejati P., Masoumi Shahre Babak N., Sobhani Eraghi A., Nejati L., Didehvar K., Mazaherinezhad A.

Laboratory Study on Tendon Injury, Rotator Cuff, Shoulder Pain, published in J Orthop (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
Laboratory Study
Journal
J Orthop (2026)
Country
India
Reported sample size
—
PMID
41503230
DOI
10.1016/j.jor.2025.12.025

Abstract (original English)

Rotator cuff injuries are the underlying cause of shoulder pain in 65-70 % of the patients over the age of 50. A novel therapeutic approach is stem cell therapy, which promises to heal. This study represents one of the first long-term safety evaluations of autologous adipose-derived mesenchymal stem cells (MSCs) in human subjects with total rotator cuff tear, with a specific focus on potential adverse effects. This study was designed as a pilot safety phase within a broader clinical trial framework. Ten patients with full-thickness rotator cuff tears were enrolled. Autologous mesenchymal stem cells (MSCs), derived from adipose tissue, were injected directly into the torn tendons under ultrasound guidance. Patients were monitored over a 36-month period to assess safety outcomes. These included complete blood count (CBC), inflammatory markers-erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP)-radiological imaging (X-ray and MRI), pain assessment via visual analog scale (VAS), and functional status through validated questionnaires. No systemic or local adverse events were reported during the 36-month follow-up, indicating a favorable safety profile. The CBC parameters after three years compared to the baseline measurement: hemoglobin [mean = 13.92 (SD = 1.32) vs. 13.85 (1.34)], red blood cells [mean = 4.97 (SD = 0.31) vs. 5.11 (0.31)], white blood cells [mean = 6.05

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 CuffShoulder Pain
View on PubMedDOI

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