Journal Article•
Treatment of osteoarthritis with autologous and microfragmented adipose tissue
TL;DR: The intra-articular injection of autologous, microfragmented adipose tissue for treatment of knee OA seems safe and Randomised controlled trials are needed to elucidate the efficacy of the treatment.
Abstract: Introduction Osteoarthritis (OA) is the leading cause of disability in elderly people. Several non-invasive solutions have been proposed with varying success rates. Recently, new therapeutic approaches, such as the use of minimally manipulated tissue products, have gained increasing popularity. The purpose of this study was to investigate the safety and feasibility of a single intra-articular injection of autologous, microfragmented adipose tissue in patients with knee OA. Methods The study was performed as a prospective cohort study. Microfragmented adipose tissue was obtained using a minimal manipulation technique (Lipogems). The safety of the procedure was evaluated by recording the type and incidence of any adverse events at three months. The clinical outcomes were determined using the Knee injury and Osteoarthritis Outcome Score (KOOS) scale at three, six and 12 months of follow-up. Results Twenty patients were included in the study and all participated in the follow-up. Only one adverse event was registered; a patient complaint of cosmetic changes to the abdominal subcutaneous tissue. The improvements in KOOS were significant at all follow-up. At one year, KOOS pain had improved by 14 points, symptoms by seven, activity of daily living by 13, sports by 19 and quality of life by 15. Conclusions The intra-articular injection of autologous, microfragmented adipose tissue for treatment of knee OA seems safe. Randomised controlled trials are needed to elucidate the efficacy of the treatment. Trial registration This study was registered in ClinicalTrials.gov (NCT02697682). Funding none.
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TL;DR: Mechanically isolated SVF offers a safe, easy and legal treatment modality for a range of indications and future research is indicated to identify the optimal isolation protocol, dose and timing.
25 citations
TL;DR: In this article, the authors evaluated the short-term clinical effect, therapeutic response rate (TRR), and therapy safety of a single intra-articular autologous MFAT injection for symptomatic knee OA.
Abstract: The study aimed to evaluate the short-term clinical effect, therapeutic response rate (TRR%), and therapy safety of a single intra-articular autologous MFAT injection for symptomatic knee OA. Secondly, patient- and pathology-related parameters were investigated to tighten patient selection for MFAT therapy. Sixty-four subjects with symptomatic mild–severe knee OA were enrolled in a single-center trial and received a unilateral (n = 37) or bilateral (n = 27) MFAT injection. After liposuction, the adipose tissue was mechanically processed with the Lipogem® device, which eventually produced 8–10 cc of MFAT. Subjects were clinically assessed by means of the KOOS, NRS, UCLA, and EQ-5D at baseline and 1, 3, 6, and 12 months after injection. Adverse events were recorded at each follow-up timepoint. The TRR was defined according to the OMERACT-OARSI criteria and baseline MRI was scored following the MOAKS classification. The TRR of the index knee was 64% at 3 months and 45% at 12 months after injection. Therapy responders at 12 months improved with 28.3 ± 11.4 on KOOS pain, while non-responders lost −2.1 ± 11.2 points. All clinical scores, except the UCLA, improved significantly at follow-up compared to baseline (p < 0.05). In the bilateral cohort, no difference in baseline scores or TRR was found between the index knee and contralateral knee (n.s.). An inflammatory reaction was reported in 79% of knees and resolved spontaneously within 16.6 ± 13.5 days after MFAT administration. Numerous bone marrow lesions (BML) were negatively correlated with the TRR at 12 months (p = 0.003). The study demonstrated an early clinical improvement but a mediocre response rate of 45% at 12 months after a single intra-articular injection with autologous MFAT. Assessment of bone marrow lesions on MRI can be helpful to increase the therapeutic responsiveness of MFAT up to 70% at 12 months. In comparison to repetitive injection therapies such as cortisone, hyaluronic acid, and PRP, administration of MFAT might become a relevant alternative in well-selected patients with symptomatic knee OA.
9 citations
TL;DR: Even if the Study is preliminary, echo-assisted anal-lipofilling could be considered as a feasible and safe alternative technique in the management of the fecal incontinence in non-responding ARMs patients.
Abstract: Aim of the study: To assess the efficacy of a novel technique (echo-assisted intersphincteric autologous microfragmented adipose tissue injection, also called “anal-lipofilling”) in the management of non-responsive fecal incontinence in children born with anorectal malformations (ARMs). Methods: Following ethical committee approval (CHPED-MAR-18-02), anal-lipofilling was proposed to patients with fecal incontinence not responsive to medications or bowel management (bowel enema and/or transanal irrigation automatic systems), then a prospective study was conducted. Anal-lipofilling consisted of three phases: lipoaspiration from the abdominal wall, processing of the lipoaspirate with a Lipogems system and intersphincteric injection of the processed fat tissue via endosonographic assistance. A questionnaire based on Krickenbeck’s scale (KS) was administered to the patients to evaluate the clinical outcome. Main Results: Four male patients (three recto-urethral fistula, and one recto-perineal fistula) underwent the anal-lipofilling procedure at a mean age of 13.0 ± 4.2 yrs. There were no complications during or after the procedure. From an initial assessment of the patients there was an improvement in the bowel function at a median follow up of 6 months, with better scores at KS (100% Soiling grade three pre-treatment vs. 75% grade one post-treatment). Conclusions: Even if our Study is preliminary, echo-assisted anal-lipofilling could be considered as a feasible and safe alternative technique in the management of the fecal incontinence in non-responding ARMs patients. More studies are still necessary to support the validity of the implant of autologous adipose tissue in the anal sphincter as a therapy for fecal incontinence in children born with ARMs.
7 citations
TL;DR: The use of orthobiologics for hip disorders was discussed in this article. But the paucity of guidelines for the production and characterization of the biological products leads to uneven results across the literature.
Abstract: Orthobiologics are biological materials that are intended for the regeneration or healing of bone, cartilage and soft tissues. In this review we discuss the use of orthobiologics for hip disorders providing an update. The orthobiologics included in this article are hyaluronic acid, platelet rich plasma, bone marrow, adipose tissue and expanded mesenchymal stem cells. We explain the concepts and definitions of each orthobiological product, and the literature regarding its use in the hip joint. The paucity of guidelines for the production and characterization of the biological products leads to uneven results across the literature. Each biologic therapy has indications and benefits; however, noteworthy are the characterization of the orthobiologics, the application method and outcome analysis for further improvement of each technique.
6 citations
TL;DR: In this article , the effectiveness of microfragmented adipose tissue (mFAT) applied in association with arthroscopic debridement (AD) for the treatment of knee OA, in terms of symptoms relief and tissue healing was evaluated.
Abstract: Abstract Purpose Current conservative treatments for knee OA provide limited benefits, with symptoms relief for a short amount of time. Regenerative medicine approaches such as the use of microfragmented adipose tissue (mFAT) showed promising results in terms of durable effects and the possibility to enhance tissue healing and counteract the progression of the pathology. Nevertheless, up to today, the large part of clinical data about mFAT use refers to uncontrolled studies, especially in the surgical setting. The purpose of this study was to evaluate the effectiveness of mFAT applied in association with arthroscopic debridement (AD) for the treatment of knee OA, in terms of symptoms relief and tissue healing. Methods This study is a prospective, randomized controlled clinical trial. 78 patients affected by knee OA grade 3–4 according to KL classification were randomly assigned to AD or AD + mFAT treatment groups. Clinical, radiological and serological assessments were performed at 6 months after treatment. Additional clinical evaluation was performed at the end of the study with an average follow-up of 26.1 ± 9.5 months. VAS, KOOS, WOMAC and SF-12 were also collected at both timepoints, KSS only at 6 months. Results Treatment with AD + mFAT improved functional scores at both 6 months (KOOS-PS: + 11.7 ± 20.2 vs + 24.4 ± 22.5, in AD and AD + mFAT, respectively, p = 0.024; KSS: + 14.9 ± 15.9 vs + 24.8 ± 23.5, in AD and AD + mFAT, respectively, p = 0.046) and 24-month follow-ups (KOOS-PS Functional subscale: − 2.0 ± 3.5 vs − 4.7 ± 4.2, in AD and AD + mFAT, respectively, p = 0.012). Lower T2-mapping scores were obtained in AD + mFAT-treated group in medial and lateral condyle compartments ( p < 0.001). Slight increase was observed in the levels of a serum biomarker of cartilage deposition (PIIINP) in both groups at 6-month follow-up ( p = 0.037). Conclusion mFAT improves functional outcome and MRI appearance when used in association with AD, therefore supporting its use in the treatment of knee OA in an arthroscopic setting.
6 citations
References
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TL;DR: The KOOS is a valid, reliable and responsive self-administered instrument that can be used for short-term and long-term follow-up of several types of knee injury including osteoarthritis.
Abstract: The Knee injury and Osteoarthritis Outcome Score (KOOS) was developed as an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis. The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). The KOOS has been validated for several orthopaedic interventions such as anterior cruciate ligament reconstruction, meniscectomy and total knee replacement. In addition the instrument has been used to evaluate physical therapy, nutritional supplementation and glucosamine supplementation. The effect size is generally largest for the subscale QOL followed by the subscale Pain. The KOOS is a valid, reliable and responsive self-administered instrument that can be used for short-term and long-term follow-up of several types of knee injury including osteoarthritis. The measure is relatively new and further use of the instrument will add knowledge and suggest areas that need to be further explored and improved.
1,672 citations
"Treatment of osteoarthritis with au..." refers background or methods in this paper
...The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis....
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...The clinical outcomes were determined using the Knee injury and Osteoarthritis Outcome Score (KOOS) scale at three, six and 12 months of follow-up....
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...The KOOS holds 42 items in five separately scored subscales: Pain, Symptoms, Function in daily living, Function in Sport and Recreation, and knee-related Quality of Life....
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...A statistically significant improvement in KOOS was seen in all subscales....
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...A change of ten points or more was considered clinically relevant [11]....
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TL;DR: Evidence that leads to the proposal that during local injury, MSCs are released from their perivascular location, become activated, and establish a regenerative microenvironment by secreting bioactive molecules and regulating the local immune response is discussed.
1,402 citations
TL;DR: This review focuses on the specific articular cartilage and skeletal features of OA and the putative mechanisms involved in their pathogenesis.
Abstract: The articular surface plays an essential role in load transfer across the joint, and conditions that produce increased load transfer or altered patterns of load distribution accelerate the development of osteoarthritis (OA). Current knowledge segregates the risk factors into two fundamental mechanisms related to the adverse effects of "abnormal" loading on normal cartilage or "normal" loading on abnormal cartilage. Although chondrocytes can modulate their functional state in response to loading, their capacity to repair and modify the surrounding extracellular matrix is limited in comparison to skeletal cells in bone. This differential adaptive capacity underlies the more rapid appearance of detectable skeletal changes, especially after acute injuries that alter joint mechanics. The imbalance in the adaptation of the cartilage and bone disrupts the physiological relationship between these tissues and further contributes to OA pathology. This review focuses on the specific articular cartilage and skeletal features of OA and the putative mechanisms involved in their pathogenesis.
746 citations
"Treatment of osteoarthritis with au..." refers background in this paper
...Osteoarthritis (OA) of the knee is a destructive joint disease causing degeneration of cartilage, damage to the underlying bone and morphological changes to the joint [1]....
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TL;DR: Estimating direct and indirect arthritis-attributable costs to individuals with disabling hip and/or knee osteoarthritis from two regions of Ontario, Canada found costs incurred were mainly for time lost from employment and leisure, and for unpaid informal caregivers.
Abstract: Objective. To estimate the direct and indirect arthritis-attributable costs to individuals with disabling hip and/or knee osteoarthritis (OA). Methods. An established population cohort with disabling hip and/or knee OA from two regions of Ontario, Canada was surveyed to determine participant and caregiver costs related to OA, and the predictors of these costs. Results. The response rate was 87.2%. Of 1378 respondents, 1258 had OA (mean age 73.1 yr, range 59–100). Sixty per cent (n^ 758) reported OA-related costs. Among these individuals, the average annual cost was $12 200 ($CDN in 2002, where $1.00 CDN $0.81 US). Time lost from employment and leisure by participants and their unpaid caregivers accounted for 80% of the total. Men were less likely than women to report costs (adjusted odds ratio 0.54, P_0.0001), but when they did their expenditures were significantly higher (P^ 0.004). Greater disability was associated with higher costs: compared with individuals with WOMAC total scores _15, those with scores ¸55 were 15 times more likely to report costs, and their costs were 3 times greater (both P_0.0001). Both the young (_65 yr) and very old were more likely to incur costs (P_0.0001), and when they did their costs were higher (P_0.001). Conclusion. Costs incurred were mainly for time lost from employment and leisure, and for unpaid informal caregivers. Failure to value such indirect costs significantly underestimates the true burden of OA. Costs increased with worsening health status and greater OA severity. After adjustment, men were less likely to incur costs, possibly due to greater social resources.
383 citations
"Treatment of osteoarthritis with au..." refers background in this paper
...It is a major public health concern due to the increased life expectancy of the ageing population [2]....
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TL;DR: Demonstration that neither partial infections nor tumours appeared in these patients provided strong evidence for the safety of autologous BMSC transplantation, and this procedure is a safe procedure and will be widely used around the world.
Abstract: Among autologous somatic stem cells, bone marrow-derived mesenchymal stem cells (BMSCs) are the most widely used worldwide to repair not only mesenchymal tissues (bone, cartilage) but also many other kinds of tissues, including heart, skin, and liver. Autologous BMSCs are thought to be safe because of the absence of immunological reaction and disease transmission. However, it is possible that they will form tumours during long-term follow-up. In 1988, we transplanted autologous BMSCs to repair articular cartilage, which was the first such trial ever reported. Subsequently we performed this procedure in about 40 patients. Demonstration that neither partial infections nor tumours appeared in these patients provided strong evidence for the safety of autologous BMSC transplantation. Thus, in this study we checked these patients for tumour development and infections. Between January 1998 and November 2008, 41 patients received 45 transplantations. We checked their records until their last visit. We telephoned or mailed the patients who had not visited the clinics recently to establish whether there were any abnormalities in the operated joints. Neither tumours nor infections were observed between 5 and 137 (mean 75) months of follow-up. Autologous BMSC transplantation is a safe procedure and will be widely used around the world.
306 citations
"Treatment of osteoarthritis with au..." refers background in this paper
...No serious adverse effects like infection or tumour formation have been observed in the treatment of OA with mesenchymal stem cells or minimally manipulated tissue products [16]....
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