Within the context of current medical practice for knee osteoarthritis the safety profile of ACBI appear to compare well with knee replacements and arthroscopies, with the risks extremely small and the potential benefits great.
Published clinical studies report a lack of serious adverse effects with ACBIs.
Animal AE Studies
- Vet-Stem reported in 2007, on 4,000 horses that had been treated with intra-articular injection of SVF. They reported a total number of 42 adverse events (short term local pain and swelling) being rate of 0.73%, and no systemic complications . To June 2012, Vet-Stem had treated a total of 5,571 horses and 5,961 dogs with a total of 118 local adverse events and no systemic events, with a corresponding adverse event rate of 1.02% (Unpublished data). Local adverse events included mild to significant local pain and inflammation.
Clinical AE Reports
- A study on 616 knee osteoarthritis patients that underwent BM with or without adipose graft reported three severe AE with none related to the procedure, and 8.9% non-serious adverse events .
- Yoshimura et al reported on the use of SVF-assisted lipotransfer for breast augmentation [3, 4] and facial lipopysirophy . Of the 61 patients with a 2 year follow up, and adverse events were 2 breast microcalcification, 2 fibrosis, 1 cyst formation (<12mm).
- A documented report of abnormal bone growth when a filler (Hydroxyapatite) was added with a fat graft and SVF. Hydroxyapatite is known to be a powerful inducer of osteogenesis and this may have the signal that these cells responded to or hydoxyapatite has been reported to cause granuloma’s to become calcified .
- SVF transplantation caused an inflammatory granulomatous synovitis, recent use of Synvisc (hylan G-F 20) injections into this joint for osteoarthritis may also be the reason or, unintentional injection into an extra-articular structure may have caused the granulomatous synovitis (unpublished data).
- It has been reported that there is a risk of disseminated intravascular coagulation (DIC) if the SVF cells are not carefully prepared and filtered, similar to bone marrow concentrate risk when used intravenously.
- Infection from injection of cells is the most common significant adverse event reported in the literature. This most likely arises from non-sterile technique in the processing of the adipose in the laboratory or from contamination during injection [5-8].
- In 2017 a NEJM paper reported severe adverse events in 3 patients treated with SVF for AMD from the one clinic in the USA. Vision loss occurred after intravitreal injection of SVF with PRP in both eyes; dissociation of SVF from the tissue was enzyme based .
- Black, L.L., et al., Effect of adipose-derived mesenchymal stem and regenerative cells on lameness in dogs with chronic osteoarthritis of the coxofemoral joints: a randomized, double-blinded, multicenter, controlled trial. Vet Ther, 2007. 8(4): p. 272-84.
- Centeno, C., et al., Efficacy of autologous bone marrow concentrate for knee osteoarthritis with and without adipose graft. Biomed Res Int, 2014. 2014: p. 370621.
- Yoshimura, K., et al., Cell-assisted lipotransfer for facial lipoatrophy: efficacy of clinical use of adipose-derived stem cells. Dermatol Surg, 2008. 34(9): p. 1178-85.
- Yoshimura, K., et al., Cell-assisted lipotransfer for cosmetic breast augmentation: supportive use of adipose-derived stem/stromal cells. Aesthetic Plast Surg, 2008. 32(1): p. 48-55; discussion 56-7.
- Karussis, D. and I. Kassis, The potential use of stem cells in multiple sclerosis: an overview of the preclinical experience. Clin Neurol Neurosurg, 2008. 110(9): p. 889-96.
- Karussis, D., et al., Immunomodulation and neuroprotection with mesenchymal bone marrow stem cells (MSCs): a proposed treatment for multiple sclerosis and other neuroimmunological/neurodegenerative diseases. J Neurol Sci, 2008. 265(1-2): p. 131-5.
- Slavin, S., B.G. Kurkalli, and D. Karussis, The potential use of adult stem cells for the treatment of multiple sclerosis and other neurodegenerative disorders. Clin Neurol Neurosurg, 2008. 110(9): p. 943-6.
- Yamout, B., et al., Bone marrow mesenchymal stem cell transplantation in patients with multiple sclerosis: a pilot study. J Neuroimmunol, 2010. 227(1-2): p. 185-9.
- Kuriyan, A.E., et al., Vision Loss after Intravitreal Injection of Autologous “Stem Cells” for AMD. N Engl J Med 2017. 376:1047-53.