Safety of intra-articular cell-therapy with culture-expanded stem cells in humans: a systematic literature review

Peeters, Charles M M; Leijs, M.J.; Reijman, Max; Osch, G.J. van; Bos, P.K.

doi:10.1016/j.joca.2013.06.025

Cited by 146 publications

(114 citation statements)

References 40 publications

(34 reference statements)

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“…They divided patients in 3 groups, administrating 10×10e 6 , 50×10e 6 and 100×10e 6 MSC. The outcomes showed intra-articular knee injection of 100×10e 6 autologous MSC improved function and pain as well as cartilage defects by regeneration of hyaline-like articular cartilage [56].…”

Section: Discussionmentioning

confidence: 99%

Treatment of Knee Osteoarthritis with Autologous Expanded Bone Marrow Mesenchymal Stem Cells: 50 Cases Clinical and MRI Results at One Year Follow-Up

R¹,

Munar²,

F³

et al. 2015

J Stem Cell Res Ther

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Section: Discussionmentioning

confidence: 99%

Treatment of Knee Osteoarthritis with Autologous Expanded Bone Marrow Mesenchymal Stem Cells: 50 Cases Clinical and MRI Results at One Year Follow-Up

R¹,

Munar²,

F³

et al. 2015

J Stem Cell Res Ther

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“…Recently, a systematic review of the literature was published which evaluated the safety of cell therapies expanded in culture for intraarticular use in humans [23]. It was concluded that the application of cultured cells in human joints seems to be a safe procedure.…”

Section: Discussionmentioning

confidence: 99%

Cell Therapies in the Treatment of Temporomandibular Osteoarthritis: A Systematic Review of the Literature

Tesch¹

2014

J Interdiscipl Med Dent Sci

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Therapeutic strategies for the management of temporomandibular osteoarthritis ideally involve the improvement in pain and functional disability, as well as delay the progression and promote the repair of joint cartilage defects. Cell therapies have emerged as a new, minimally invasive therapeutic modality that allows for the use of autologous cell transplantation, and may involve adult undifferentiated mesenchymal stem/stromal cells (MSC) or differentiated cell lineage,like condrocytes.The aim of this study was to review the existing controlled clinical trials that evaluate the efficacy and safety of these different types of cell therapy in adult patients with temporomandibular joint(TMJ) osteoarthritis. The parameters used to search the literature and retrieve these studies, as well as the assessments of eligibility criteria,have followed the recommendations of the PRISMA Statement. A highly sensitive search strategy was held in the Medline (1966Medline ( -2013and Central Register of Controlled Trials(1960-2013)databases. The latest search was carried out on Dec 27,2013. Different combinations of keywords were used, temporomandibular joint, temporomandibular disorders, craniomandibular dysfunction, stem cells, mesenchymal cells and autologous condrocytes, yielded 101 clinical trials. Most of these trials, however, were related to osteoarthitis of the knees. No clinical trials were conducted in patients with TMJ osteoarthritis. There is no evidence from randomized controlled trials to demonstrate the safety and effectiveness of different types of cellular therapies for the treatment of osteoarthritis of the TMJ. There is an urgent need to perform clinical trials in this area in order to benefit patients with advanced processes who are refractory to conservative or conventional minimally invasive therapeutic modalities.

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“…19,20 This progression consisted of injecting all sorts of agents that induce a biological response, including: dextrose, sodium bicarbonate/calcium gluconate, hyaluronic acid, platelet rich plasma (PRP), bone marrow aspirate concentrate (BMAC), nano or micronized fat, adipose-stromal vascular fraction (A-SVF), culture expanded meschymal stem cells (CE-MSCs) both allogenic as well as autologous from a multitude of sources are becoming more commonplace. 16 The aggregate number and quality of studies are steadily improving, it is no doubt that the application of the cells are safe 10,12,21,22 and efficacious. 16 …”

Section: History Of Regenerative Medicine-cartilagementioning

confidence: 99%

“…[35][36][37][38] The basis for intervention has been the interpretation of stem cell therapies as high-risk biologic treatments despite data to the contrary. 10,12,21,22,39 Although an increasing number of warning letters to multiple clinics have been sent by the FDA, there are still numerous facilities that are operational and offering a full range of treatments to include administration of culture expanded cells, SVF delivered by intraarticular, intravenous, epidural, intra-discal, as well intrathecal transplantations. The US-FDA divides biologic therapies into low-risk and high-risk therapies by determining if the product has undergone minimal manipulation and autologous use (Fig.…”

Section: Regulatory Implications Facing Cartilage Regenerative Medicinementioning

confidence: 99%

Concepts in regenerative medicine: Past, present, and future in articular cartilage treatment

Anz

Bapat²,

Murrell

2016

Journal of Clinical Orthopaedics and Trauma

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Regenerative medicine is emerging with great interest and hope from patients, industry, academia, and medical professionals. Cartilage regeneration, restoration, or repair is one of the prime targets that remains largely unsolved, and many believe that regenerative medicine can possibly deliver solutions that can be widely used to address the current gap(s) in treatment. In the United States, Europe, Australia, and India the regulation of regenerative based treatments has become a big debate. Although the rules and regulations remain unclear, clinicians that are interested should carry-on with the best available guidelines to ensure safety and compliance during delivery in clinical practice to avoid regulatory infraction. Many have made significant investment of time, resources, and facilities in recent years to provide new regenerative treatment options and advance medical care for patients. Instead of reinventing the wheel, it would be more efficient to adopt currently accepted standards and nomenclature borrowed from transplantation science, and cord blood storage industries. The purposes of this article are to provide some historical background to the field of regenerative medicine as it applies to cartilage, and how this field has developed. This will be followed by a separate discussion on regulatory oversight and input and how it has influenced access to care. Furthermore, we discuss current clinical techniques and progress, and ways to deliver these treatments to patients safely, effectively, and in a cost sensitive manner, concluding with an overview of some of the promising regenerative techniques specific to cartilage.

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Safety of intra-articular cell-therapy with culture-expanded stem cells in humans: a systematic literature review

Abstract: Based on current literature review we conclude that application of cultured stem cells in joints appears to be safe. We believe that with continuous caution for potential side effects, it is reasonable to continue with the development of articular stem cell therapies.

Cited by 146 publications

References 40 publications

Treatment of Knee Osteoarthritis with Autologous Expanded Bone Marrow Mesenchymal Stem Cells: 50 Cases Clinical and MRI Results at One Year Follow-Up

Treatment of Knee Osteoarthritis with Autologous Expanded Bone Marrow Mesenchymal Stem Cells: 50 Cases Clinical and MRI Results at One Year Follow-Up

Cell Therapies in the Treatment of Temporomandibular Osteoarthritis: A Systematic Review of the Literature

Concepts in regenerative medicine: Past, present, and future in articular cartilage treatment

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