Effects of the intradiscal implantation of stromal vascular fraction plus platelet rich plasma in patients with degenerative disc disease
Kristin Comella, Robert Silbert, Michelle Parlo, Kristin Comella, Robert Silbert, Michelle Parlo
Abstract
Background: Stromal vascular fraction (SVF) can easily be obtained from a mini-lipoaspirate procedure of fat tissue and platelet rich plasma (PRP) can be obtained from peripheral blood. The SVF contains a mixture of cells including ADSCs and growth factors and has been depleted of the adipocyte (fat cell) population. We evaluated the safety and efficacy of administering SVF and PRP intra-discally into patients with degenerative disc disease.
Methods: A total of 15 patients underwent a local tumescent liposuction procedure to remove approximately 60 ml of fat tissue. The fat was separated to isolate the SVF and the cells were delivered into the disc nucleus of patients with degenerative disc disease. The subjects were then monitored for adverse events, range of motion, visual analog scale (VAS), present pain intensity (PPI), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), Dallas Pain Questionnaire and Short Form (SF)-12 scores over a period of 6 months. Safety events were followed for 12 months.
Results: No severe adverse events (SAEs) were reported during a 12 month follow up period with no incidences of infection. Patients demonstrated statistically significant improvements in several parameters including flexion, pain ratings, VAS, PPI, and short form questionnaires. In addition, both ODI and BDI data was trending positive and a majority of patients reported improvements in their Dallas Pain Questionnaire scores.
Conclusions: Overall, patients were pleased with the treatment results. More importantly, the procedure demonstrated a strong safety profile with no severe adverse events or complications linked to the therapy. Trial registration NCT02097862. Name of registry: www.clinicaltrials.gov . https://ichgcp.net/clinical-trials-registry/NCT02097862?term=bioheart&rank=6 . Date of registration: March 25, 2014; Date of enrollment: March 2014.
Keywords: Adipose derived stromal/stem cells (ADSCs); Adipose tissue; Back pain; Cell therapy; Degenerative disc disease; Platelet rich plasma (PRP); Stem cells; Stromal vascular fraction (SVF).
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References
- Hematti P, Keating A. Mesenchymal stromal cells in regenerative medicine: A Perspective. In: Hematti P, Keating A, editors. Mesenchymal stromal cells—Biology and clinical applications. New York: Humana Press; 2013. pp. 3–16.
- Przybyt E, Harmsen MC. Mesenchymal stem cells: promising for myocardial regeneration. Curr Stem Cell Res Ther. 2013;8(4):270–277. doi: 10.2174/1574888X11308040002.
- Caplan AI, Correa D. The MSC: an injury drugstore. Cell Stem Cell. 2011;9(1):11–15. doi: 10.1016/j.stem.2011.06.008.
- Minteer D, Marra KG, Rubin JP. Adipose-derived mesenchymal stem cells: biology and potential applications. Adv Biochem Eng Biotechnol. 2013;129:59–71.
- Bunnell B. Adipose-derived stem cells for regenerative medicine. Circ Res. 2007;00:1249–1260.
- Rehman J, Traktuev D, Li J, Merfeld-Clauss S, Temm CJ, Bovenkerk JE, Pell C, Johnstone B, Considine RV, March KL. The secretion of angiogenic and anti-apoptotic factors by human adipose stromal cells. Circulation. 2004;109(10):1291–1298. doi: 10.1161/01.CIR.0000121425.42966.F1.
- Traktuev DO, Merfeld-Clauss S, Li J, Kolonin M, Arap W, Pasqualini R, Johnstone BH, March KL. A population of multipotent CD34-positive adipose stromal cells share pericyte and mesenchymal surface markers, reside in a periendothelial location, and stabilize endothelial networks. Circ Res. 2008;102(1):77–85. doi: 10.1161/CIRCRESAHA.107.159475.
- Panfilov IA, de Jong R, Takashima S, Duckers HJ. Clinical study using adipose-derived mesenchymal-like stem cells in acute myocardial infarction and heart failure. Methods Mol Biol. 2013;1036:207–212. doi: 10.1007/978-1-62703-511-8_16.
- Jang Y, Koh YG, Choi YJ, Kim SH, Yoon DS, Lee M, Lee JW. Characterization of adipose tissue-derived stromal vascular fraction for clinical application to cartilage regeneration. Vitro Cell Dev Biol Anim. 2015;51(2):142–150. doi: 10.1007/s11626-014-9814-6.
- Aust I, Devlin B, Foster SJ, Halverson YD, Hicok K, du Laney T, et al. Yield of Human adipose- derived adult stem cells from liposuction aspirates. Cytotherapy. 2004;6:7–14. doi: 10.1080/14653240310004539.
- Song K, Gu T, Shuang F, Tang J, Ren D, Qin J, Hou S. Adipose-derived stem cells improve the viability of nucleus pulposus cells in degenerated intervertebral discs. Mol Med Rep. 2015;12(3):4664–4668.
- Marfia G, Campanella R, Navone SE, et al. Potential use of human adipose mesenchymal stromal cells for intervertebral disc regeneration: a preliminary study on biglycan-deficient murine model of chronic disc degeneration. Arthritis Res Ther. 2014;16(5):457. doi: 10.1186/s13075-014-0457-5.
- Chun HJ, Kim YS, Kim BK, et al. Transplantation of human adipose-derived stem cells in a rabbit model of traumatic degeneration of lumbar discs. World Neurosurg. 2012;78:364–371. doi: 10.1016/j.wneu.2011.12.084.
- Tuakli-Wosornu YA, Terry A, Boachie-Adjei K, Harrison JR, Gribbin CK, LaSalle EE, Nguyen JT, Solomon JL, Lutz GE. Lumbar intradiskal platelet-rich plasma (PRP) injections: a prospective, double-blind, randomized controlled study. Am J Phys Med Rehabil. 2016;8(1):1.
- Pettine K, Suzuki R, Sand T, Murphy M. Treatment of discogenic back pain with autologous bone marrow concentrate injection with minimum two year follow-up. Int Orthop. 2016;40(1):135–140. doi: 10.1007/s00264-015-2886-4.
- Orozco L, Soler R, Morera C, Alberca M, Sánchez A, García-Sancho J. Intervertebral disc repair by autologous mesenchymal bone marrow cells: a pilot study. Transplantation. 2011;92(7):822–828. doi: 10.1097/TP.0b013e3182298a15.
- Ullrich P. Laminectomy and spinal stenosis: risks and complications—Spine-health. 2009.
Source: PubMed