Intratendinous adipose-derived stromal vascular fraction (SVF) injection provides a safe, efficacious treatment for Achilles tendinopathy: results of a randomized controlled clinical trial at a 6-month follow-up

Usuelli, Federico Giuseppe; Grassi, Miriam; Maccario, Camilla; Viganò, Marco; Lanfranchi, Luciano; Montrasio, Umberto Alfieri; Girolamo, Laura de

doi:10.1007/s00167-017-4479-9

Cited by 118 publications

(134 citation statements)

References 44 publications

(63 reference statements)

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“…A recent review on four studies of stem cell therapy for human tendinopathy showed some positive results; however, the lack of controls, non-randomisation and small sample size make general conclusions difficult to assess 75. A recent RCT demonstrated improvement in outcomes in patients who received adipose-derived stem cell injections compared with PRP injections at 13 and 30 days but not other time points 76. Larger studies are being conducted, but at the moment there is not enough evidence to recommend stem cell therapy for AT.…”

Section: Discussionmentioning

confidence: 99%

Treatment of Achilles tendinopathy: state of the art

Ackermann

Phisitkul²,

Pearce

2018

Journal of ISAKOS

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Section: Discussionmentioning

confidence: 99%

Treatment of Achilles tendinopathy: state of the art

Ackermann

Phisitkul²,

Pearce

2018

Journal of ISAKOS

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“…SVF is an attractive therapeutic method given that the harvesting process is safe and the cells are readily available in large quantities. The use of SVF has been reported in a variety of indications including osteoarthritis [11-13], degenerative disc disease [14], sclerosis [15], tendinopathy [16], congestive heart failure [17], chronic obstructive pulmonary disease (COPD) [18], radiation necrosis [19], xerostomia [20], and multiple sclerosis [21]. …”

Section: Introductionmentioning

confidence: 99%

Safety Analysis of Autologous Stem Cell Therapy in a Variety of Degenerative Diseases and Injuries Using the Stromal Vascular Fraction

et al. 2017

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BackgroundStem cells from adipose tissue offer a novel therapy for patients with damaged tissue. Stromal vascular fraction (SVF) injected into patients may reduce inflammation, promote healing, and repair damaged/scarred tissue. SVF can be isolated from fat (adipose) tissue in an outpatient procedure. The SVF population includes mesenchymal stem cells (MSCs), pericytes, endothelial/progenitor cells, fibroblasts and growth factors where the adipocyte (fat cell) population has been removed. Here we describe the use of SVF in the clinic for degenerative diseases in orthopedics, neurological conditions and systemic conditions in 676 patients.MethodsThis study demonstrated the strong safety profile from a multi-center analysis of SVF injection in treating various diseases. Approximately 60 mL of fat tissue was removed from the abdomen or flanks using a local tumescent liposuction procedure. The fat was separated via centrifuge to isolate the SVF and the cells were delivered intraarticularly, intravenously, intrathecally, or intradiscally directly into the same patient. All subjects were monitored for adverse events.ResultsThe procedure demonstrates exceptional patient safety, and the study underscores the safety of autologous stem cell therapy in general. Few adverse events were reported and were overwhelmingly of mild and transient nature, such as the expected soreness at the site of liposuction and occasional headache.ConclusionThe three deaths reported were most likely not related to the treatment but instead to the underlying disease. Our study demonstrates a strong safety profile with low complication rates.

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“…Since SVF extraction does not remove non-cellular components to the degree accomplished through culture expansion, safety studies must be conducted to evaluate the outcome of intravenous SVF infusion. The use of SVF has been reported in a variety of indications including osteoarthritis [9], degenerative disc disease [10], sclerosis [11], congestive heart failure [12], multiple sclerosis [13] and tendinopathy [14]. Intravenous infusion of SVF has indeed been demonstrated to be safe in some small studies [13], yet no study to date has evaluated the safety of non-culture expanded SVF in a patient series, particularly in subjects with COPD.…”

Section: Introductionmentioning

confidence: 99%

Autologous Stromal Vascular Fraction in the Intravenous Treatment of End-Stage Chronic Obstructive Pulmonary Disease: A Phase I Trial of Safety and Tolerability

et al. 2017

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BackgroundChronic obstructive pulmonary disease (COPD) is a consistently progressive, ultimately fatal disease for which no treatment exists capable of either reversing or even interrupting its course. It afflicts more than 5% of the population in many countries, and it accordingly represents the third most frequent cause of death in the US, where it accounts for more than 600 billion in health care costs, morbidity, and mortality. Adipose tissue contains within its stromal compartment a high abundance of adipose stem/stromal cells (ASCs), which can be readily separated from the adipocyte population by methods which require less than 2 h of processing time and yield a concentrated cellular preparation termed the stromal vascular fraction (SVF). The SVF contains all cellular elements of fat, excluding adipocytes. Recent clinical studies have begun to explore the feasibility and safety of the local injection or intravascular delivery of SVF or more purified populations of ASCs derived by culture protocols. Several pre-clinical studies have demonstrated a remarkable ability of ASC to nearly fully ameliorate the progress of emphysema due to cigarette smoke exposure as well as other causes. However, no prior clinical studies have evaluated the safety of administration of either ASC or SVF in subjects with COPD. We hypothesized that harvest, isolation, and immediate intravenous infusion of autologous SVF would be feasible and safe in subjects with COPD; and that such an approach, if ultimately determined to be efficacious as well as safe, would provide a highly practical method for treatment of COPD.MethodsIn this study, an initial phase I trial evaluating the early and delayed safety of SVF infusion was performed. Twelve subjects were enrolled in the study, in which adipose tissue was harvested using standard liposuction techniques, followed by SVF isolation and intravenous infusion of 150 - 300 million cells. Standardized questionnaires were administered to study feasibility as well as immediate and delayed outcomes and adverse events as primary endpoints. Secondary endpoints included subjective wellness and attitudes towards the procedure, as well as willingness to undergo the procedure a second time. The follow-up time ranged from 3 to 12 months, averaging 12 months.ResultsOf the 12 subjects, only one experienced an immediate adverse event, related to bruising from the liposuction. No observed pulmonary or cardiac issues were observed as related to the procedure. There were no deaths over the 12-month study period, and none identified in the subsequent telephonic follow-up. Attitudes toward the procedure were predominantly positive, and 92% of the study subjects expressed a desire to undergo the procedure a second time.ConclusionsThis study is the first to demonstrate safety of SVF infusion in humans with serious pulmonary disease. Specifically, the use of intravenous infusion as a route to achieve pulmonary cellular targeting did not lead to clinical pulmonary compromise. The intravenous administration of SVF shou...

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Intratendinous adipose-derived stromal vascular fraction (SVF) injection provides a safe, efficacious treatment for Achilles tendinopathy: results of a randomized controlled clinical trial at a 6-month follow-up

Abstract: Randomized Controlled Clinical Trial, Level 1.

Cited by 118 publications

References 44 publications

Treatment of Achilles tendinopathy: state of the art

Treatment of Achilles tendinopathy: state of the art

Safety Analysis of Autologous Stem Cell Therapy in a Variety of Degenerative Diseases and Injuries Using the Stromal Vascular Fraction

Autologous Stromal Vascular Fraction in the Intravenous Treatment of End-Stage Chronic Obstructive Pulmonary Disease: A Phase I Trial of Safety and Tolerability

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