Adipose-derived regenerative cells may improve function in patients with partial-thickness rotator cuff tears
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Published results showed use of uncultured, unmodified, autologous adipose-derived regenerative cells may be safe and may improve shoulder function without adverse effects in patients with symptomatic, partial-thickness rotator cuff tears.
Nicola Maffulli, MD, PhD, MS, FRCS(Orth), and colleagues randomly assigned patients with symptomatic, partial-thickness rotator cuff tears who did not respond to physical therapy treatments for at least 6 weeks to receive either a single injection of fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (n=11) or a single injection of 80 mg of methylprednisolone plus 3 mL of 0.25% bupivacaine (n=5). Researchers isolated the uncultured, unmodified, autologous adipose-derived regenerative cells from patients’ own adipose tissue using the Transpose RT System (InGeneron). Researchers assessed safety and efficacy using the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, research and development SF-36 health survey and VAS pain score at baseline and 3, 6, 9, 12, 24, 32, 40 and 52 weeks postoperatively. Researchers also performed fat-saturated T2-weighted MRI of the shoulder at baseline and at 24 and 52 weeks postoperatively.
In the 12 months after treatment, results showed no severe adverse events related to the injection of adipose-derived regenerative cells. Researchers found patients treated with adipose-derived regenerative cells did not experience greater risks compared to patients treated with corticosteroid injection. Patients in the adipose-derived regenerative cell injection group had statistically significantly higher mean ASES total scores at 24 and 52 weeks postoperatively vs. patients in the corticosteroid injection group, according to results. Researchers noted one patient in the corticosteroid group developed a full rotator cuff tear during the study.
“Our study, the first to compare the results of using adipose tissue in a human’s torn rotator cuff to using corticosteroid treatment, gave us definite results: Fresh, uncultured, unmodified, autologous adipose-derived regenerative cells isolated from lipoaspirate at point of care is safe and more effective than corticosteroid injections, with MRI evidence of tissue regeneration. On the other hand, 20% of the patients involved in the study who received a corticosteroid jab showed progression of the rotator cuff tear,” Maffulli told Healio Orthopedics. “These are exciting and encouraging results, and have prompted us to plan further studies to refine our technique and indications.” – by Casey Tingle
Disclosures: Maffulli reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
Perspective
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Asheesh Bedi, MD
Nicola Maffulli, MD, PhD, MS, FRCS(Orth), and colleagues are to be congratulated on a well-executed safety study looking into the use of non-manipulated, autologous, adipose-derived stem cells (InGeneron) for the treatment of symptomatic partial-thickness rotator cuff tears in patients. The numbers are small, the tear types are heterogeneous and there was a high attrition rate of enrollment. Nonetheless, the results suggest slight superiority to corticosteroid injection for patient-reported outcomes at 1 year, but no difference in structural healing of tendon defects. Future double-blinded studies that are higher powered for healing outcomes can build on this work, and second-look biopsies may lend insights into the mechanism of action. Cells that remain viable may be working through direct incorporation, as well as paracrine pathways, to modify inflammation and the healing response.
Gehring professor of orthopedic surgery
Ann Arbor, Michigan
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