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

Comella, Kristin; Parlo, Michelle; Daly, Rosemary; Depasquale, Vincent; Edgerton, Eric S.; Mallory, Patrick; Schmidt, Roy C.; Drake, Walter P

doi:10.14740/jocmr3187w

Cited by 26 publications

(20 citation statements)

References 25 publications

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“…Side effects or patient discomforts or complaints were recorded as adverse events (AEs). According to similar study conducted by Comella et al [18], any event that is life-threatening and led to hospitalization or required major medical intervention is categorized as serious adverse events (SAEs). All other events, side effects, or patient complaints/discomforts were collected as adverse events (AEs).…”

Section: Data Collection and Analysismentioning

confidence: 99%

“…It is well known that MSCs secrete proangiogenic cytokines, such as vascular endothelial growth factor (VEGF), angiopoietin-1 (Angpt-1), hepatocyte growth factor (HGF), and insulin-like growth factor-binding proteins (IGFBPs) to promote cells regeneration [ 13 ]. To date, stromal or mesenchymal stem cell application has been used to treat many diseases and conditions, including osteoarthritis [ 14 ], rheumatoid arthritis [ 15 ], chronic obstructive pulmonary disease (COPD) [ 16 ], heart disease, Lyme disease, Crohn's disease/colitis, autoimmune diseases, diabetes, lower limb vascular disease, kidney failure, neurological symptoms, degenerative disc disease, vaginal dryness, urinary incontinence, hair loss and alopecia [ 17 ], fat grafting [ 18 ], multiple sclerosis [ 19 ], and retinitis pigmentosa [ 20 ] and for aesthetic purposes [ 21 ].…”

Section: Introductionmentioning

confidence: 99%

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Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell Administration

Karina¹,

Rosliana²,

Rosadi³

et al. 2020

Scientifica

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Background. Stromal vascular fraction (SVF) therapy has been performed over the past six years to treat 421 patients by our group in five clinical centers. Autologous SVF, which is a substance containing stem cells, was isolated from lipoaspirate, mixed with platelet-rich plasma (PRP), and administered to patients with degenerative diseases, autoimmune diseases, trauma, aging, and other diseases with unknown etiology. This study aimed to determine the safety of SVF and PRP that were given through infusion, spinal, and intra-articular injection. Methods. The lipoaspirate was treated with a tissue-dissociating enzyme, and then, through centrifugation, SVF was isolated. In addition, blood was drawn from each patient, and PRP was isolated. Autologous PRP and SVF were administered to all subjects by intravenous (IV) injection. A minority group within the population received an additional spinal or intra-articular injection. The type of intervention was determined by each disease evaluation. The cell doses and adverse events for each patient were documented and analyzed. Results. Cell dose that was considered to be safe was less than 10 billion SVF cells in 250 cc of normal saline, for IV injection, and less than 1 billion SVF, for intra-articular and spinal injection. Adverse events were not severe and were treated successfully. Any observed adverse events were identified as a result of spinal or intra-articular injections and were not related to SVF or PRP. Conclusions. Our results showed that administration of high dose of SVF until 10 billion cells in a majority of 421 patients through infusion, spinal, and intra-articular injection was feasible without causing major adverse events and should be further investigated in well-designed phase I-II clinical trial to address the safety and efficacy of therapy.

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Section: Data Collection and Analysismentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell Administration

Karina¹,

Rosliana²,

Rosadi³

et al. 2020

Scientifica

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“… 24 In addition, two studies have been published demonstrating the safety of SVF for a variety of indications used in a clinical outpatient setting. 25 , 26 With a large number of MSCs and a low number of white blood cells, adipose tissue is a more ideal source for in-clinic cellular medicine as compared to bone marrow. 27 Adipose tissue also contains a large number of pericytes which are the precursor to MSCs with regenerative or healing properties.…”

Section: Introductionmentioning

confidence: 99%

First-in-man intravenous implantation of stromal vascular fraction in psoriasis: a case study

Comella¹,

Parlo²,

Daly³

et al. 2018

IMCRJ

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BackgroundStromal vascular fraction (SVF) is a mixture of adipose-derived stem cells/mesenchymal stem cells, endothelial/progenitors, pericytes, fibroblasts, and other cells obtained from fat tissue. A small sample of fat or adipose tissue can be obtained under local anesthesia using a cannula. After an enzymatic digestion and centrifugation, the adipocytes (fat cells) are removed to obtain an SVF. Here, we describe the rationale and, to our knowledge, the first clinical implementation of SVF intravenously in a patient with severe psoriasis.MethodsAdipose tissue (60 mL) was collected under local anesthesia via a mini-lipoaspirate procedure. The SVF was separated from the adipocytes via centrifugation after an enzymatic digestion. The cells were resuspended in normal saline and injected via bolus push intravenous. The subject was monitored over a period of 12 months for safety (adverse events), medication changes, and quality of life parameters.ResultsThe patient did not report any safety concerns and did not experience any severe adverse events. The patient demonstrated a significant decrease in symptoms with a noticeable difference in skin quality appearance. Psoriasis area and severity index score went from 50.4 at baseline to 0.3 at 1 month follow-up.ConclusionOverall, the patient reported improved quality of life and willingness to continue treatments. This successful initial case study demonstrates that this may be a feasible treatment plan for patients suffering from psoriasis.

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“…Fat tissue can be easily and safely harvested and SVF can be collected bedside making it an attractive therapeutic option for physicians to offer to their patients [19]. A variety of publications have reported on the injection of SVF including: osteoarthritis [20, -21], degenerative disc disease [22], sclerosis [23], tendinopathy [24], congestive heart failure [25], chronic obstructive pulmonary disease (COPD) [26], radiation necrosis [27], xerostomia [28], psoriasis [29], and multiple sclerosis [30].…”

Section: Introductionmentioning

confidence: 99%

Intra-Articular Implantation of Stromal Vascular Fraction Plus Platelet Rich Plasma in a Degenerative Meniscal Injury

Comella

Greenberg²,

Ross³

2018

J Med Cases

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Regenerative medicine and specifically stem cell therapy is growing in popularity in a variety of orthopedic conditions including meniscal injuries. Stromal vascular fraction (SVF) which is easily obtained from adipose (fat tissue) is a mixture of adipose derived stem cells/ mesenchymal stem cells, pericytes, fibroblasts, progenitor/endothelial cells, and other cells. A mini-lipoaspiration procedure to obtain a small sample of fat can be completed using a cannula under local anesthesia. The SVF is separated from the adipocytes (fat cells) using enzyme digestion and centrifugation. Platelet rich plasma (PRP) from the peripheral blood is a mixture of growth factors and cytokines. We present a case study and to our knowledge first in man with a before and after arthroscopic evaluation showing the repair of a meniscal tear using SVF plus PRP. Adipose tissue (65 mL) was removed via a mini-lipoaspirate procedure under local anesthesia. Approximately 5 mL of whole fat was washed and prepared for injection. For the remaining 60 mL of fat, the adipocytes were removed after enzyme digestion and centrifugation to isolate the SVF. PRP (approximately 4 mL) was used to resuspend the cells for an intra-articular injection. The patient received five additional PRP injections of 2.5 mL at 3 -4 week intervals. The patient was monitored over a 12-month period for safety (including severe adverse events (SAEs) and adverse events) and quality of life parameters. In addition, an arthroscopic evaluation was completed at baseline and 9 months post procedure. There were no reported SAEs or other safety complications during the procedure or the follow-up time period. The patient demonstrated reduction of pain with clearly visible repair on the arthroscopic evaluation. The patient expressed an overall improvement in quality of life and willingness to repeat PRP treatments. Based on the outcomes of this case study, intra-articular injection of SVF plus PRP could be a feasible treatment plan for a patient with chronic meniscus injury.

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

Cited by 26 publications

References 25 publications

Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell Administration

Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell Administration

First-in-man intravenous implantation of stromal vascular fraction in psoriasis: a case study

Intra-Articular Implantation of Stromal Vascular Fraction Plus Platelet Rich Plasma in a Degenerative Meniscal Injury

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