Treatment of Lateral Epicondylosis by Using Allogeneic Adipose-Derived Mesenchymal Stem Cells: A Pilot Study

Abstract

Mesenchymal stem cell therapy is a novel regenerative approach for treating tendinopathy. Here, we evaluated the safety and efficacy of allogeneic adipose-derived mesenchymal stem cells (allo-ASC) in treating lateral epicondylosis (LE). Under ultrasound guidance, allo-ASCs mixed with fibrin glue were injected into the hypoechoic common extensor tendon lesions of 12 participants with chronic LE; 6 subjects each were administered 10 6 or 10 7 cells in 1 ml. Safety was evaluated at day 3 and weeks 2, 6, 12, 26, and 52 post-injection. Efficacy was assessed by measuring patients' visual analog scale (VAS) score for elbow pain, modified Mayo clinic performance index for the elbow, and by evaluating longitudinal and transverse ultrasound images of tendon defect areas after 6, 12, 26, and 52 weeks. No significant adverse effects of allo-ASC injection were observed through 52 weeks of follow-up. From baseline through 52 weeks of periodic follow-up, VAS scores progressively decreased from 66.8 6 14.5 mm to 14.8 6 13.1 mm and elbow performance scores improved from 64.0 6 13.5 to 90.6 6 5.8. Tendon defects also significantly decreased through this period. Allo-ASC therapy was thus safe and effective in improving elbow pain, performance, and structural defects for 52 weeks. This clinical study is the first to reveal therapeutic value of mesenchymal stem cell injection for treating chronic tendinopathy. STEM CELLS 2015;33:2995-3005 SIGNIFICANCE STATEMENTClinical use of mesenchymal stem cells in the treatment of tendinopathy has not been well studied because it may be related to the invasive procedures required to obtain autologous stem cells. Allogeneic stem cells may be an optimal treatment option for tendinopathy, if safety and efficacy can be conclusively demonstrated. Here, we evaluated the safety and efficacy of allogeneic adipose-derived mesenchymal stem cells in treating chronic lateral epicondylosis of 12 participants. No significant adverse effects of allogeneic stem cells were observed through 52 weeks of follow-up. Elbow pain, performance scores, and tendon defects area measured by ultrasound improved through this period. This clinical study is the first to reveal therapeutic value of mesenchymal stem cell injection for treating chronic tendinopathy.

No evidence for the use of stem cell therapy for tendon disorders: a systematic review

“…One unpublished trial42 was found to be published36 and had already been included in the results. Two unpublished trials43 45 were finalised at the time of writing the manuscript (June 2016).…”

“…Two studies34 35 evaluated the use of bone marrow-derived stem cells as an additive treatment for rotator cuff repair. One study36 investigated the use of allogenic adipose-derived stem cells in lateral epicondylar tendinopathy. The last study41 investigated the use of bone marrow-derived stem cells in patellar tendinopathy.…”

Adipose Tissue-Derived Mesenchymal Stem Cells: A Novel Therapy in Orthopedics

“…Thirteen articles were included in the review, they consisted of 1 RCT, 4 nRCTs, 1 prospective comparative study, 1 longitudinal cohort study, 2 case control studies, 3 case series and one case report [68,[73][74][75][76][77][78][79][80][81][82][83][84]. The number of patients injected with stem cells ranged between 12 and 1128.…”

Safety and Effectiveness of Intraarticular Administration of Adipose-Derived Stromal Vascular Fraction for Treatment of Knee Articular Cartilage Degenerative Damage: Preliminary Results of a Clinical Trial

“…Zuk с соавторами (2001,2002) была по-казана принципиальная возможность участия ММСКжт в процессах регенерации скелетных тканей [16,20]. В дальнейших доклинических исследованиях и клинических наблюдениях была продемонстрирована эффективность при-менения СВФ и культивированных ММСКжт в ортопедии [27,28]. В настоящее время накоп-лено большое количество результатов клини-ческих исследований, посвященных использо-ванию культивированных ММСК, выделенных рис.…”

“…Несмотря на хорошие результаты, технология лечения, основанная на применении культиви-рованных ММСК, имеет серьезное ограничение: для получения клеточного продукта необходим этап культивирования клеток в специальной лаборатории в стерильных условиях в соответ-ствии с рекомендациями профессиональных со-обществ и требованиями надлежащих практик [10,27,28,30]. поскольку в большинстве стран мира культивированные клеточные продукты должны быть зарегистрированы по процедуре, схожей с регистрацией лекарственных средств, то многие исследователи ориентируются на СВФ, которая может быть получена в однора-зовой закрытой системе «у постели» больного и применена в рамках одной хирургической процедуры.…”