Six trials with high risk of bias showed level-3 or level-4 evidence in favour of stem cell injections in KOA. In the absence of high-level evidence, we do not recommend stem cell therapy for KOA.

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Background: Stem cell therapy is an emerging treatment for tendon disorders. Purpose: To systematically review the efficacy of stem cell therapy for patients with tendon disorders. Study Design: Systematic review; Level of evidence, 4. Methods: MEDLINE/PubMed, EMBASE, CINAHL, CENTRAL, PEDro, and SPORTDiscus; trial registers; and gray literature were searched to identify randomized controlled trials (RCTs) and non-RCTs, cohort studies, and case series with 5 or more cases. Studies investigating any type of stem cell therapy for patients with tendon disorders were eligible if they included patient-reported outcome measures or assessed tendon healing. Risk of bias was assessed through use of the Cochrane risk of bias tools. Results: This review included 8 trials (289 patients). All trials had moderate to high risk of bias (level 3 or 4 evidence). In Achilles tendon disorders, 1 trial found that allogenic-derived stem cells led to a faster recovery compared with platelet-rich plasma. Another study found no retears after bone marrow–derived stem cell therapy was used in addition to surgical treatment. There were 4 trials that studied the efficacy of bone marrow–derived stem cell therapy for rotator cuff tears. The controlled trials reported superior patient-reported outcomes and better tendon healing. A further 2 case series found that stem cell therapy improved patient-reported outcomes in patients with patellar tendinopathy and elbow tendinopathy. Conclusion: Level 3 evidence is available to support the efficacy of stem cell therapy for tendon disorders. The findings of available studies are at considerable risk of bias, and evidence-based recommendations for the use of stem cell therapy for tendon disorders in clinical practice cannot be made at this time. Stem cell injections should not be used in clinical practice given the lack of knowledge about potentially serious adverse effects.

ObjectiveStem cell therapy is increasingly used for knee osteoarthritis (KOA). We aimed to review the evidence of autologous mesenchymal stem cell therapy on pain, function and severity on imaging in KOA.DesignSystematic review of randomised controlled trials (RCTs).Eligibility criteriaRCTs evaluating autologous mesenchymal stem cell (MSC) therapy on patient-reported outcome measures and disease severity.Data sourcesSeven databases were searched until 31 December 2020.Risk of bias and data synthesisRisk of bias was assessed using the ROB V.2. We used Grading of Recommendations Assessment, Development and Evaluation to appraise the certainty of the evidence. Data were synthesised descriptively.ResultsFourteen RCTs were included. A total of 408 patients with KOA received MSC therapy derived from bone marrow, adipose tissue or activated peripheral blood. After 1 year, 19 of 26 (73%) clinical outcome measures improved with MSCs compared with control. In the MSC group, patients improved by 1.8–4.4 points on the Visual Analogue Scale (0–10) and 18–32 points of the Knee Osteoarthritis Outcome Score (0–100). Four studies showed better disease severity on imaging after MSC compared with control at 1 year. Ten of 14 (71%) RCTs were at high risk of bias on all outcomes. No serious adverse events were reported after MSC therapy during a maximum of 4 years follow-up.ConclusionWe found a positive effect of autologous MSC therapy compared with control treatments on patient-reported outcome measures, and disease severity. The certainty of this evidence was low to very low.PROSPERO registration numberCRD42019120506

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