What are the downsides of autologous tenocyte implantations?
I have read a couple of research articles that seem to be quite laudative toward autologous tenocyte implantation (ATI):
(1) presents a successful recovery for partial-thickness rotator cuff tear and tendinopathy in an elite athlete using ATI.
(2) lists a few upsides / positive findings:
The efficacy of tendon cell use for tendon repair has been verified in a number of in vitro and animal studies, (33-35). Animal studies have revealed
that implantation of in vitro-expanded autologous tenocytes improved the tendon structure and facilitated the healing process in both an acute
tendon tear model, (33) and a chronic degenerative tendon disease model, (35).
Clinical applications of Ortho-ATI injections have demonstrated reduced pain and inflammation, restoration of fibre structure, reduction in vascular
hyperplasia, and improved cellular morphology. This indicates that injection of in vitro-expanded autologous tenocytes alters the progression of
tendinopathy. (35)"
(3) also only contains positive results, though I have only be able to access the abstract so far (despite my university library paying millions of USD every year for journal subscriptions, and asking a colleague of mine working in one of the largest French medical university):
The mean final follow-up time for the remaining 15 patients was 4.51 years (range, 3.08-5.17 years). No complications were observed at the patellar tendon biopsy site for any patient. No adverse events, infection, or excessive fibroblastic reactions were observed in any patient at the injection site. Clinical evaluation revealed significant (P < .001) improvement in mean VAS pain score from 5.73 at initial assessment to 1.21 (78% improvement) at final follow-up. Mean QuickDASH, UEFS, and grip strength scores also significantly (P < .001) improved from initial assessment to final follow-up (from 45.88 to 6.61 [84%], from 31.73 to 9.20 [64%], and from 19.85 to 46.60 [208%], respectively). There was no difference in mean QuickDASH and UEFS scores at 1 year and final follow-up (P > .05); however, grip strength continued to improve (P < .001). A validated MRI scoring system indicated that the mean grade of tendinopathy at the common extensor origin improved significantly (P < .001) from initial assessment (4.31) to 1 year (2.88) and was maintained (P > .05) at final follow-up (2.87). At final follow-up, 93% of patients were either highly satisfied or satisfied with their ATI treatment.
What are the downsides / risks of autologous tenocyte implantations, if any, aside from:
the tendon biopsy (from a non-injured tendon in the patient), which is needed to obtain tendon samples to grow tenocytes from. (How long does it take to recover from a biopsy of a tendon?)
the usual risk of the injection, when injecting the grown tenocytes in the injured tendon
?
I am mostly interested in the lateral epicondyle of the humerus.
(1), (2), and (3) all have conflicts of interest (at least one author works for a firm that aims to make profits from autologous tenocyte implantations).
References:
(1) Wang, Allan W., et al. "Autologous tenocyte implantation, a novel treatment for partial-thickness rotator cuff tear and tendinopathy in an elite athlete." BMJ case reports 2013 (2013): bcr2012007899.
(2) Zheng, Ming Hao, Paul Anderson, and Jerome Waddell. Orthocell's Ortho-ATI: Tendon Regeneration. Vol. 1. Jerome Waddell, 2014.
(3) Wang, Allan, et al. "Evidence for the Durability of Autologous Tenocyte Injection for Treatment of Chronic Resistant Lateral Epicondylitis Mean 4.5-Year Clinical Follow-up." The American journal of sports medicine (2015): 0363546515579185.
(33) Chen, J.M., Willers, C., Xu, J., Wang, A., and Zheng, M.H. Autologous tenocyte therapy using porcine-derived bioscaffolds for massive rotator
cuff defect in rabbits. Tissue Eng 13, 1479, (2007)
(34) Y. Bi, et al., Nature Med., 10, 1219 (2007).
(35) J. Chen, et al., Achilles Tendinopathy in a Rabbit Model TISSUE ENGINEERING., Part A. 17, 2037 (2011).
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