Randomized clinical trial: expanded autologous bone marrow mesenchymal cells combined with allogeneic bone tissue, compared with autologous iliac crest graft in lumbar fusion surgery

Frutos, Ana García de; González-Tartière, Pilar; Coll-Bonet, Ruth; Garcés, María Teresa Ubierna; Churruca, Alejandro del Arco; García, Antoni Rivas; Adrover, Miquel; Bru, Guillem Saló; Velázquez, Juan José; Vilà-Canet, Gemma; García‐López, Joan; Vives, Joaquim; Codinach, Margarita; Rodríguez, Laura; Granell, Joan Bagó; Palou, Enric Cáceres

doi:10.1016/j.spinee.2020.07.014

Cited by 28 publications

(40 citation statements)

References 36 publications

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“…Regarding clinical trials involving application of ADSCs to degenerative spondylolisthesis, one study covered by this review reported that the use of 3D graft made of autologous ADSCs in patients receiving minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) resulted in significant improvement in the VAS score and the ODI and achievement of grade 3 fusion without donor site complications [ 196 ]. Although only one study did not guarantee the clinical benefit of using ADSCs for degenerative spondylolisthesis so that further studies are required, a very recent study where a combination of BM-MSC and allogeneic graft achieved a higher rate of posterior spinal fusion and radiographic complete response without significant AEs [ 211 ] also suggests the potential of ADSCs, or stem cells in general, as alternative therapeutics for degenerative spondylolisthesis.…”

Section: Type Of Msds Targetedmentioning

confidence: 99%

ADSC-Based Cell Therapies for Musculoskeletal Disorders: A Review of Recent Clinical Trials

Lee

Chae

Song

et al. 2021

IJMS

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Recently published clinical trials involving the use of adipose-derived stem cells (ADSCs) indicated that approximately one-third of the studies were conducted on musculoskeletal disorders (MSD). MSD refers to a wide range of degenerative conditions of joints, bones, and muscles, and these conditions are the most common causes of chronic disability worldwide, being a major burden to the society. Conventional treatment modalities for MSD are not sufficient to correct the underlying structural abnormalities. Hence, ADSC-based cell therapies are being tested as a form of alternative, yet more effective, therapies in the management of MSDs. Therefore, in this review, MSDs subjected to the ADSC-based therapy were further categorized as arthritis, craniomaxillofacial defects, tendon/ligament related disorders, and spine disorders, and their brief characterization as well as the corresponding conventional therapeutic approaches with possible mechanisms with which ADSCs produce regenerative effects in disease-specific microenvironments were discussed to provide an overview of under which circumstances and on what bases the ADSC-based cell therapy was implemented. Providing an overview of the current status of ADSC-based cell therapy on MSDs can help to develop better and optimized strategies of ADSC-based therapeutics for MSDs as well as help to find novel clinical applications of ADSCs in the near future.

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Section: Type Of Msds Targetedmentioning

confidence: 99%

ADSC-Based Cell Therapies for Musculoskeletal Disorders: A Review of Recent Clinical Trials

Lee

Chae

Song

et al. 2021

IJMS

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“…No previous sample size calculation was made because of the pilot nature of this study. Patients were randomised to either one of the two study treatments described next: 1) Treatment A (experimental): mechanical stabilisation (if required) associated with a Tissue Engineering Product (TEP composed of ex vivo expanded autologous Mesenchymal Stromal Cells (MSC) loaded onto allogeneic cancellous bone graft described previously ( Prat et al, 2018 ; García de Frutos et al, 2020 ) and prepared in accordance with current Good Manufacturing Practices as reported elsewhere ( Codinach et al, 2016 ; Vives et al, 2021 ; García-Muñoz and Vives, 2021 ); and 2) Treatment B (control): mechanical stabilisation, if required, associated with autologous iliac crest graft (gold standard) ( Fig. 1 , Fig.…”

Section: Methodsmentioning

confidence: 99%

A pilot study of circulating levels of TGF-β1 and TGF-β2 as biomarkers of bone healing in patients with non-hypertrophic pseudoarthrosis of long bones

et al. 2022

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Background Pseudoarthrosis or non-union is a complication with an incidence of 5–10% of bone fractures, most frequently located in the diaphysis of long bones. The management of this complication is addressed by means of complex surgical procedures and is a concern for orthopaedic and trauma surgeons nowadays. The use of biomarkers for diagnosing patients at risk of non-union would help us to establish special measures for early corrective treatment. Methods Prospective exploratory pilot study with a cohort of 20 patients diagnosed of non-hypertrophic pseudoarthrosis of long bones who were treated surgically with either autologous bone graft or a Tissue Engineering Product composed of bone marrow-derived Mesenchymal Stromal Cells. Patients were followed for 12 months and plasma blood samples were obtained to determine circulating levels of Transforming Growth Factor Beta 1 and Beta 2 (TGF-β1 and TGF-β2, respectively) at inclusion, and at 1 week, 2 weeks, and months 1, 2, 3, 6 and 12 after surgery. Radiological bone healing was evaluated by the Tomographic Union Score (TUS). Results Basal levels of TGF-β1 and TGF-β2 were determined in the twenty patients (26,702 ± 14,537 pg/mL and 307.8 ± 83.1 pg/mL, respectively). Three of them withdrew from the study, so complete follow-up was conducted on 17 patients (9 successfully healed vs. 8 that did not heal). Statistically significant differences between the bone healing group and the non-union group were found at month 12 for both TGF-β1 ( p = 0.005) and TGF-β2 ( p = 0.02). Conclusions TGF-β1 and TGF-β2 are biomarkers that correlate with clinical evidence of bone regeneration and may be used to monitor patients, although early predictive value after intervention needs to be further studied in combination with other molecules.

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“…All that is FDA approved and considered osteoinductive is demineralized freeze‐dried bone allograft (DFDBA) 18 . However, seeding allografts with mesenchymal stem cells (MSCs) have improved their osteogenic behavior in human and animal studies 2,19–21 . Hence, allografts may present a sustainable alternative to autografts.…”

Section: Classificationmentioning

confidence: 99%

A novel classification of bone graft materials

2022

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Over the past few decades, the field of biomaterials concerning bone tissue engineering has gained a significant amount of interest. This has led to new biomaterials to be used as bone substitute materials. Despite the rapid increase in the types and forms of bone substitutes, a comprehensive classification encompassing all types of bone graft materials that have so far been developed and evaluated is lacking. Therefore, this review aims to integrate and bring together the published data on bone substitutes within the last 5 years and produce a novel classification that would provide bone material researchers with a better understanding of what materials have so far been used and evaluated and the areas, where research is lacking and deserves more attention. The literature available in all major databases was obtained and filtered using an elimination criterion to extract all the articles related to studies that tested bone substitute materials in nonclinical and clinical trials over the last 5 years. The review article would provide bone material researchers with an insight into the materials that have been evaluated for bone tissue engineering applications and identify future perspectives for bone graft material research.

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Randomized clinical trial: expanded autologous bone marrow mesenchymal cells combined with allogeneic bone tissue, compared with autologous iliac crest graft in lumbar fusion surgery

Cited by 28 publications

References 36 publications

ADSC-Based Cell Therapies for Musculoskeletal Disorders: A Review of Recent Clinical Trials

ADSC-Based Cell Therapies for Musculoskeletal Disorders: A Review of Recent Clinical Trials

A pilot study of circulating levels of TGF-β1 and TGF-β2 as biomarkers of bone healing in patients with non-hypertrophic pseudoarthrosis of long bones

A novel classification of bone graft materials

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