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

Several human studies show positive signals, while research methods and sample sizes continue to develop.

• 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)

Background 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. Methods 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. Results 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)], whi

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

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