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Does an Injection of Adipose-Derived Mesenchymal Stem Cells Loaded in Fibrin Glue Influence Rotator Cuff Repair Outcomes? A Clinical and Magnetic Resonance Imaging Study

Yong Sang Kim, Chang Hun Sung, Sung Hoon Chung, Sang Joon Kwak, Yong Gon Koh
American Journal of Sports Medicine 2017, 45 (9): 2010-2018
28448728

BACKGROUND: The mesenchymal stem cell (MSC)-based tissue engineering approach has been developed to improve the treatment of rotator cuff tears. Hypothesis/Purpose: The purpose was to determine the effect of an injection of adipose-derived MSCs loaded in fibrin glue during arthroscopic rotator cuff repair on clinical outcomes and to evaluate its effect on structural integrity using magnetic resonance imaging (MRI). The hypothesis was that the application of adipose-derived MSCs would improve outcomes after the surgical repair of a rotator cuff tear.

STUDY DESIGN: Cohort study; Level of evidence, 3.

METHODS: Among 182 patients treated with arthroscopic surgery for a rotator cuff tear, 35 patients treated with arthroscopic rotator cuff repair alone (conventional group) were matched with 35 patients who underwent arthroscopic rotator cuff repair with an injection of adipose-derived MSCs loaded in fibrin glue (injection group) based on sex, age, and lesion size. Outcomes were assessed with respect to the visual analog scale (VAS) for pain, range of motion (ROM) (including forward flexion, external rotation at the side, and internal rotation at the back), and functional measures of the Constant score and University of California, Los Angeles (UCLA) shoulder rating scale. Repaired tendon structural integrity was assessed by using MRI at a minimum of 12 months after surgery, and the mean clinical follow-up was 28.8 ± 4.2 months in the conventional group and 28.3 ± 3.8 months in the injection group.

RESULTS: The mean VAS score at rest and during motion improved significantly in both groups after surgery. However, there were no significant differences between the groups at the final follow-up ( P = .256 and .776, respectively). Compared with preoperative measurements, forward flexion and external rotation at the side significantly improved at the final follow-up in both groups (all P < .05). However, no significant improvements in internal rotation at the back were observed in either group ( P = .625 and .834 for the conventional and injection groups, respectively). There were also no significant differences between the groups at the final follow-up for any of the 3 ROM positions (all P > .05). The mean Constant score and UCLA score improved significantly in both groups after surgery, but there were no significant differences between the groups at the final follow-up ( P = .634 and .302, respectively). MRI indicated a retear rate of 28.5% in the conventional group and 14.3% in the injection group ( P < .001).

CONCLUSION: This study revealed that an injection of adipose-derived MSCs loaded in fibrin glue during rotator cuff repair could significantly improve structural outcomes in terms of the retear rate. There were, however, no clinical differences in the 28-month period of follow-up. Although still in the early stages of application, MSC augmentation of surgical rotator cuff repair appears useful for providing an adequate biological environment around the repair site.

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David Coradin

Wait on second thought.

1. Both groups didn't get treated the same except for the MSCs. Because the MSCs were applied in a fibrin glue. Which the other group did not get any fibrin glue. This is major in view of the retear statistic. Was the MSCs. Or was it the fibrin glue?

2. No intent to treat analysis. No blinding or randomization. The selection of the patients for the groups was apparently at high risk for selection bias, since the final group then also underwent "matching". What were they matched on? Etc.

3. Subgroup analysis on the conventional per protocol group on their Work activity. Because if somehow in the selection process the ones that work in labor and lifting or exercise fanatics were in the conventional group then that would damper the results of less retear in the intervention group who were in office work.

I think the biggest success of the study which was not mentioned is the SAFETY of using MSCs for the procedure. Maybe in an appendix the process for isolation can be described or the percent of live nucleated cells injected if that was analyzed. But safety is the name of the game first and foremost. The statistical significance for the results is great but the main issue is the study design possibly leading to multiple opportunities for bias.

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David Coradin

Impressive outcome

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