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Stem Cell and Regenerative Injections

What stem-cell and bone-marrow-derived injections claim to do for joints and tendons, what the evidence actually shows, and the safety and regulatory caveats.

Overview

Mesenchymal stem cell injections represent a growing area of research in traumatology and orthopaedics [2]. While these cells have been used in clinical practice in accordance with government health regulations [5], their application should be guided by the pathophysiology of the target disease and follow regulatory frameworks to ensure safe and effective use [5]. Currently, there is insufficient evidence to recommend stem cell injections for knee osteoarthritis in clinical practice at this time [1]. Consequently, stem cell injections for knee osteoarthritis should continue to be studied in rigorous trials [1].

Specific modalities show distinct profiles. Intra-articular injection of umbilical cord–derived mesenchymal stem cells is safe and effective for moderate to severe knee osteoarthritis with synovitis [7]. Treatment with these cells showed clinical improvement at the end of follow-up, with particular improvement in patients with moderate to severe pain [7]. The combination of platelet-rich plasma and adipose-derived mesenchymal stem cells demonstrated enhanced therapeutic efficacy for osteoarthritis and has potential as a treatment option [4]. However, the superiority of bone marrow aspirate concentrate over other orthobiologic treatments cannot be assessed given the conflicting results presently available [6].

Mechanistic and timing factors influence outcomes. The intervention schedule is significantly correlated with the therapeutic efficacy of stem cells for posttraumatic osteoarthritis [3]. The best effects of stem cell treatment for posttraumatic osteoarthritis are observed on days 7 and 14 after anterior cruciate ligament transection [3]. Endogenous mesenchymal stromal cells can be pharmacologically mobilized into peripheral blood and recruited to the site of rotator cuff repair via local delivery of MCP-1 [8]. Furthermore, mesenchymal stem cell-derived miR-125b-1-3p-abundant exosomes alleviate osteoarthritis by modulating the KDM6B-H3K27me3-FOXM1 axis [10]. These findings provide a theoretical rationale and identify promising therapeutic targets for the development of exosome-based therapeutic strategies against osteoarthritis [10].

Significant risk of reporting bias exists in randomized controlled trials and clinical trials of mesenchymal stromal cells for the treatment of knee osteoarthritis [9]. Abstracts of these trials show a significantly higher proportion of significant P values compared to main texts [9].

How It Works

There is insufficient evidence to recommend stem cell injections in clinical practice at this time [1]. Stem cell injections should continue to be studied in rigorous trials [1]. Mesenchymal stem cell (MSC) injections represent a growing area of research in traumatology and orthopaedics [2]. MSC application in clinical practice should be guided by the pathophysiology of the target disease [5]. MSC application in clinical practice should follow regulatory frameworks to ensure safe and effective use [5].

The intervention schedule is significantly correlated with the therapeutic efficacy of stem cells for posttraumatic osteoarthritis (PTOA) [3]. The best therapeutic effects of stem cells for PTOA are observed on days 7 and 14 after anterior cruciate ligament transection (ACLT) [3]. The combination of platelet-rich plasma (PRP) and adipose-derived stem cells (ADSCs) demonstrated enhanced therapeutic efficacy for osteoarthritis (OA) [4]. The superiority of bone marrow aspirate concentrate (BMAC) over other orthobiologic treatments cannot be assessed given conflicting results [6].

Intra-articular injection of umbilical cord-derived mesenchymal stem cells (UC-MSCs) is safe and effective for moderate to severe knee osteoarthritis with synovitis [7]. Treatment with UC-MSCs shows clinical improvement at the end of follow-up, especially in patients with moderate to severe pain [7]. Endogenous MSCs can be pharmacologically mobilized into peripheral blood [8]. Endogenous MSCs can be recruited to the site of rotator cuff repair via local delivery of MCP-1 [8].

MSC-derived miR-125b-1-3p-abundant exosomes alleviate osteoarthritis by modulating the KDM6B-H3K27me3-FOXM1 axis [10]. Local delivery of MSC-derived extracellular vesicles (MSC-EVs) embedded within an injectable collagen scaffold enhanced tendon regeneration in a rat model of collagenase-induced tendinopathy [11]. Local application of BMAC without appropriate carriers could not enhance bone-tendon interface healing [12].

Adipose-derived stem cell (ASC) interactions with the immune system are complex [13]. ASC secretome may be a well-tolerated treatment for osteoarthritis, but further studies are needed to determine its potential therapeutic benefits [13]. Hypoxic MSCs might exert therapeutic effects mediated by stimulating TGF-β [16]. Hypoxic MSCs promote the expression of COL II [16]. Hypoxic MSCs inhibit the expression of COL X [16].

What the Evidence Shows

Current evidence is insufficient to recommend stem cell injections for knee osteoarthritis in clinical practice [1]. These interventions require continued investigation through rigorous trials [1]. Mesenchymal stem cell injections constitute a growing research area in traumatology and orthopaedics [2]. However, significant reporting bias exists in randomized controlled trials and clinical trials of mesenchymal stromal cells for knee osteoarthritis, with abstracts showing a significantly higher proportion of significant P values compared to main texts [9]. Spin bias was present in most mesenchymal stromal cell-related trials for knee osteoarthritis, with a higher frequency among trials that utilized adipose-derived mesenchymal stem cells [14].

Clinical application of mesenchymal stem cells in orthopaedics and traumatology occurs in accordance with government health regulations [5]. Their use should be guided by the pathophysiology of the target disease and follow regulatory frameworks to ensure safe and effective use [5]. The superiority of bone marrow aspirate concentrate over other orthobiologic treatments cannot be assessed given the conflicting results presently available [6].

Therapeutic Efficacy and Modality: * Timing: The intervention schedule is significantly correlated with the therapeutic efficacy of stem cells for posttraumatic osteoarthritis, with the best effects observed on days 7 and 14 after anterior cruciate ligament transection in a rat model [3]. * Combination Therapy: The combination of platelet-rich plasma and adipose-derived stem cells demonstrated enhanced therapeutic efficacy for the treatment of osteoarthritis [4]. * Umbilical Cord-Derived Cells: Treatment with umbilical cord-derived mesenchymal stem cells was shown to be a viable therapeutic option for knee osteoarthritis combined with synovitis, showing clinical improvement at the end of follow-up, especially in those with moderate to severe pain [7].

Tendon and Ligament Repair: * Mobilization: Endogenous mesenchymal stromal cells can be pharmacologically mobilized into peripheral blood and recruited to the site of rotator cuff repair via local delivery of MCP-1 [8]. * Extracellular Vesicles: Local delivery of mesenchymal stem cell-derived extracellular vesicles embedded within an injectable collagen scaffold enhanced tendon regeneration in a rat model of collagenase-induced tendinopathy [11]. * BMAC Without Carriers: Local application of bone marrow aspirate concentrate without appropriate carriers could not enhance bone-tendon interface healing in a rabbit model of chronic rotator cuff tear [12]. * BMAC with Allograft: Augmenting hamstring allograft anterior cruciate ligament reconstruction with an amnion collagen matrix and injecting bone marrow aspirate concentrate appeared to be safe, and clinical outcomes were favorable up to 2 years postoperation despite having no quantifiable effect on graft maturation [15]. * Structural Outcomes: Arthroscopic surgical repair combined with mesenchymal stem cell augmentation reported better structural outcomes compared to isolated surgical repair for rotator cuff tears [17].

Practical Considerations

Current Clinical Status: There is insufficient evidence to recommend stem cell injections in clinical practice at this time [1]. Mesenchymal stem cell injections represent a growing area of research in traumatology and orthopaedics [2], and the intervention should continue to be studied in rigorous trials [1]. In clinical practice, mesenchymal stem cells are used in orthopaedics and traumatology in accordance with government health regulations [5]. Their application must follow regulatory frameworks to ensure safe and effective use [5] and should be guided by the pathophysiology of the target disease [5].

Efficacy and Timing: The intervention schedule is significantly correlated with the therapeutic efficacy of stem cells for posttraumatic osteoarthritis [3]. The best effects of stem cell treatment for posttraumatic osteoarthritis are observed on days 7 and 14 after anterior cruciate ligament transection [3]. The combination of platelet-rich plasma and adipose-derived mesenchymal stem cells demonstrated enhanced therapeutic efficacy for osteoarthritis [4]. Intra-articular injection of umbilical cord-derived mesenchymal stem cells is safe and effective for moderate to severe knee osteoarthritis with synovitis [7]. Umbilical cord-derived mesenchymal stem cell treatment showed clinical improvement at the end of follow-up, especially in patients with moderate to severe pain [7].

Comparative Effectiveness and Safety: The superiority of bone marrow aspirate concentrate over other orthobiologic treatments cannot be assessed given conflicting results [6]. Augmenting hamstring allograft anterior cruciate ligament reconstruction with an amnion collagen matrix and bone marrow aspirate concentrate injection appeared safe [15]. Clinical outcomes for augmented anterior cruciate ligament reconstruction with bone marrow aspirate concentrate were favorable up to 2 years postoperation [15]. However, augmenting anterior cruciate ligament reconstruction with bone marrow aspirate concentrate had no quantifiable effect on graft maturation [15].

Adipose-Derived Stem Cells and Secretome: Adipose-derived mesenchymal stem cell interactions with the immune system are complex [13]. The secretome of adipose-derived stem cells may be a well-tolerated treatment for osteoarthritis [13]. Further studies are needed to determine the potential therapeutic benefits of adipose-derived stem cell secretome [13].

Reporting Bias: There is a significant risk of reporting bias in randomized controlled trials and clinical trials of mesenchymal stromal cells for knee osteoarthritis [9]. Abstracts of mesenchymal stromal cell trials for knee osteoarthritis show a significantly higher proportion of significant P values compared to main texts [9]. Spin bias was present in most mesenchymal stromal cell trials for knee osteoarthritis [14]. Spin bias had a higher frequency in trials that utilized adipose-derived mesenchymal stem cells [14].

Key Evidence

  • [L1] There is insufficient evidence to recommend stem cell injections in clinical practice at this time, but they should continue to be studied in rigorous trials. (10.1097/corr.0000000000003593)
  • [L2] MSC injections represent a growing area of research in traumatology and orthopaedics. (10.1186/s12891-025-09123-8)
  • [L5] The intervention schedule is significantly correlated with the therapeutic efficacy of stem cells for PTOA, with the best effects observed on days 7 and 14 after ACLT. (10.1177/03635465251326499)
  • [L5] The combination of PRP and ADSCs demonstrated enhanced therapeutic efficacy, suggesting its potential as a treatment option for OA. (10.1186/s13018-024-05396-2)
  • [L5] Mesenchymal stem cells (MSCs) have been used in clinical practice in orthopaedics and traumatology in accordance with government health regulations, but their application should be guided by the pathophysiology of the target disease and follow regulatory frameworks to ensure safe and effective use. (10.1530/eor-2026-0056)
  • [L2] However, the superiority of BMAC over other orthobiologic treatments cannot be assessed given the conflicting results presently available. (10.1186/s13018-025-06509-1)
  • [L1] Treatment with UC-MSCs was shown to be a viable therapeutic option for KOA combined with synovitis, showing clinical improvement at the end of follow-up, especially in those with moderate to severe pain. (10.1186/s12891-025-09440-y)
  • [L5] Endogenous MSCs can be pharmacologically mobilized into peripheral blood and recruited to the site of rotator cuff repair via local delivery of MCP-1. (10.1177/03635465251341439)
  • [L2] The study highlights a significant risk of reporting bias in RCTs and CTs of MSCs for the treatment of knee OA, with abstracts showing a significantly higher proportion of significant P values compared to main texts. (10.1177/23259671251374306)
  • [L5] These findings provide a theoretical rationale and identify promising therapeutic targets for the development of exosome-based therapeutic strategies against OA. (10.1186/s13018-026-06765-9)
  • [L5] Local delivery of MSC-EVs embedded within an injectable collagen scaffold enhanced tendon regeneration in a rat model of collagenase-induced tendinopathy. (10.1177/03635465261421555)
  • [L5] Local application of BMAC without appropriate carriers could not enhance bone-tendon interface healing. (10.1177/03635465241313124)
  • [L5] This study highlights the complexity of ASC interactions with the immune system, while secretome may be a well-tolerated treatment, further studies are needed to determine its potential therapeutic benefits. (10.1186/s12891-025-08642-8)
  • [L2] Spin bias was present in most MSC-related trials for knee osteoarthritis, with a higher frequency among those that utilized adipose-derived MSCs. (10.1177/03635465241274155)
  • [L4] This case series demonstrated that augmenting hamstring allograft ACL reconstruction with an amnion collagen matrix and injecting BMAC appeared to be safe, and clinical outcomes were favorable up to 2 years postoperation despite having no quantifiable effect on graft maturation. (10.1016/j.asmr.2025.101209)
  • [L5] Hypoxic MSCs might exert therapeutic effects mediated by stimulating TGF-β and subsequently promote and inhibit the expressions of COL II and COL X respectively. (10.1186/s13018-025-06184-2)
  • [L1] Arthroscopic surgical repair combined with MSC augmentation reported better structural outcomes compared to isolated surgical repair for RCT. (10.1016/j.jseint.2025.03.017)

References

[1] Cochrane in CORR ®: Stem Cell Injections for Osteoarthritis of the Knee. Clinical Orthopaedics & Related Research. 2025. DOI: 10.1097/corr.0000000000003593

[2] Mesenchymal stem cells injections in traumatology and orthopaedics: common practice or still a promising area with many uncertainties?. BMC Musculoskeletal Disorders. 2025. DOI: 10.1186/s12891-025-09123-8

[3] Days 7 to 14 May Represent an Optimal Window for Stem Cell–Based Treatment in a Rat Model of Anterior Cruciate Ligament Transection–Induced Posttraumatic Osteoarthritis. The American Journal of Sports Medicine. 2025. DOI: 10.1177/03635465251326499

[4] Adipose-derived mesenchymal stem cells combined with platelet-rich plasma are superior options for the treatment of osteoarthritis. Journal of Orthopaedic Surgery and Research. 2025. DOI: 10.1186/s13018-024-05396-2

[5] Clinical application of mesenchymal stem cells in orthopaedics and traumatology in daily practice. EFORT Open Reviews. 2026. DOI: 10.1530/eor-2026-0056

[6] Progress in the clinical use of bone marrow aspirate concentrate for knee osteoarthritis: an expert opinion. Journal of Orthopaedic Surgery and Research. 2025. DOI: 10.1186/s13018-025-06509-1

[7] Intra-articular injection of umbilical cord–derived mesenchymal stem cells is safe and effective for moderate to severe knee osteoarthritis with synovitis: a double‑blinded and randomized controlled trial. BMC Musculoskeletal Disorders. 2025. DOI: 10.1186/s12891-025-09440-y

[8] Pharmacologic Mobilization and Chemokine-Directed Recruitment of Mesenchymal Stromal Cells to the Surgically Repaired Rotator Cuff. The American Journal of Sports Medicine. 2025. DOI: 10.1177/03635465251341439

[9] Analysis of P Values in the Abstract Compared With the Main Text of Randomized Controlled Trials and Clinical Trials of Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis. Orthopaedic Journal of Sports Medicine. 2025. DOI: 10.1177/23259671251374306

[10] Mesenchymal stem cell-derived miR-125b-1-3p-abundant exosomes alleviate osteoarthritis by modulating the KDM6B-H3K27me3-FOXM1 axis. Journal of Orthopaedic Surgery and Research. 2026. DOI: 10.1186/s13018-026-06765-9

[11] Regenerative Effect of Injectable Collagen Loaded With Mesenchymal Stem Cell–Derived Extracellular Vesicles in a Collagenase-Induced Tendinopathy Rat Model. The American Journal of Sports Medicine. 2026. DOI: 10.1177/03635465261421555

[12] Bone Marrow Aspirate Concentrate Combined With an Appropriate Carrier Effectively Promotes Bone-Tendon Interface Healing in a Rabbit Model of Chronic Rotator Cuff Tear. The American Journal of Sports Medicine. 2025. DOI: 10.1177/03635465241313124

[13] Impact of adipose-derived mesenchymal stem cells and their secretome on osteoarthritis in a rat model. BMC Musculoskeletal Disorders. 2025. DOI: 10.1186/s12891-025-08642-8

[14] Evaluation of Spin in Clinical Trials of Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Systematic Review. The American Journal of Sports Medicine. 2025. DOI: 10.1177/03635465241274155

[15] Augmenting an Allograft for Anterior Cruciate Ligament Reconstruction With a Collagen Matrix and Bone Marrow Aspirate Concentrate Injection Appears Safe and Produces Favorable Clinical Outcomes at 2‐Year Follow‐Up. Arthroscopy, Sports Medicine, and Rehabilitation. 2025. DOI: 10.1016/j.asmr.2025.101209

[16] Roles of TGF-β in the therapeutic potential of hypoxic mesenchymal stem cells for treating osteoarthritis in a Rabbit model. Journal of Orthopaedic Surgery and Research. 2025. DOI: 10.1186/s13018-025-06184-2

[17] Combined arthroscopic rotator cuff repair with mesenchymal stem cell augmentation shows similar functional outcomes but a higher structural integrity rate compared with isolated repair: a meta-analysis of comparative studies. JSES International. 2025. DOI: 10.1016/j.jseint.2025.03.017

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