Autologous micro-fragmented adipose tissue for the treatment of diffuse degenerative knee osteoarthritis: an update at 3 year follow-up

A Russo, D Screpis, S L Di Donato, S Bonetti, G Piovan, C Zorzi, A Russo, D Screpis, S L Di Donato, S Bonetti, G Piovan, C Zorzi

Abstract

Background: Conservative therapies for the treatment of knee degenerative processes are used before resorting to surgery; nonetheless, they may offer only short-term benefits. Encouraging preliminary results have been reported using mesenchymal stem cells (MSCs), either alone or in association with surgery. Among the many sources, adipose tissue has created a huge interest, because of its anti-inflammatory and regenerative properties ascribed to the cells of its stromal vascular fraction. We previously reported the safety and feasibility of autologous micro-fragmented adipose tissue as adjuvant for the surgical treatment of diffuse degenerative chondral lesions at 1 year. Here we present the outcomes of the same cohort of patients evaluated at 3 year follow-up. Micro-fragmented adipose tissue was obtained using a minimal manipulation technique in a closed system. The safety of the procedure was evaluated by recording type and incidence of any adverse event. The clinical outcomes were determined using the KOOS, IKDC-subjective, Tegner Lysholm Knee, and VAS pain scales taken pre-operatively and at 12 and 36 months follow-up.

Findings: No adverse events, lipodystrophy cases at the harvesting site nor atypical inflammatory reactions at the joint level were reported. Of the 30 patients previously treated, one was lost, and seven received additional treatments in the period of observation. On average, the 22 patients that had no other treatments in the 3-year period showed that the results observed at 1 year were maintained. Moreover, 41, 55, 55 and 64% of the patients improved with respect to the 1-year follow-up in the Tegner Lysholm Knee, VAS, IKDC-subjective and total KOOS, respectively.

Conclusion: Our results point to autologous and micro-fragmented adipose tissue injection as an innovative and safe approach for the management of diffuse degenerative knee chondropathy in the mid-term. The procedure is simple, affordable, minimally invasive, and compliant with the regulatory panorama.

Conflict of interest statement

Ethics approval and consent to participate

The original study was approved by the Ethics Committee of Verona and Rovigo - Italy (protocol n° 10,227, March 1st, 2016). An extension of the study protocol has been conceded by the same authority to evaluate the results at 3 years (protocol n° 14,505, March 14th 2018). All procedures mentioned in this study were carried on in accordance with the ethical standards and with the Helsinki Declaration of 1975, as revised in 2000.

Consent for publication

Written informed consents were obtained from all patients for publication of this paper.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Trend of functional improvements of Tegner Lysholm knee, VAS pain, IKDC subjective and total KOOS pre-operatively (white bars), at 12 (grey bars) and 36 months (black bars) after micro-fragmented adipose tissue injection. Results are expressed as mean and standard error

References

    1. Ährlund-Richter L, De Luca M, Marshak DR, Munsie M, Veiga A, Rao M. Isolation and production of cells suitable for human therapy: challenges ahead. Cell Stem Cell. 2009;4(1):20–26. doi: 10.1016/j.stem.2008.11.012.
    1. Arcidiacono JA, Blair JW, Benton KA. US Food and Drug Administration international collaborations for cellular therapy product regulation. Stem Cell Res Ther. 2012;3(5):1. doi: 10.1186/scrt129.
    1. Bonasia DE, Dettoni F, Sito G, Blonna D, Marmotti A, Bruzzone M, Castoldi F, Rossi R. Medial opening wedge high tibial osteotomy for medial compartment overload/arthritis in the varus knee: prognostic factors. Am J Sports Med. 2014;42(3):690–698. doi: 10.1177/0363546513516577.
    1. Caplan AI. All MSCs are pericytes? Cell Stem Cell. 2008;3(3):229–230. doi: 10.1016/j.stem.2008.08.008.
    1. 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.
    1. Caplan AI, Dennis JE. Mesenchymal stem cells as trophic mediators. J Cell Biochem. 2006;98(5):1076–1084. doi: 10.1002/jcb.20886.
    1. De Girolamo L, Kon E, Filardo G, Marmotti A, Soler F, Peretti G, Vannini F, Madry H, Chubinskaya S. Regenerative approaches for the treatment of early OA. Knee Surg Sports Traumatol Arthrosc. 2016;24(6):1826–1835. doi: 10.1007/s00167-016-4125-y.
    1. Pak J, Lee JH, Kartolo WA, Lee SH. Cartilage regeneration in human with adipose tissue-derived stem cells: current status in clinical implications. Biomed Res Int. 2016;2016:4702674. doi: 10.1155/2016/4702674.
    1. Røtterud JH, Risberg MA, Engebretsen L, Årøen A. Patients with focal full-thickness cartilage lesions benefit less from ACL reconstruction at 2–5 years follow-up. Knee Surg Sports Traumatol Arthrosc. 2012;20(8):1533–1539. doi: 10.1007/s00167-011-1739-y.
    1. Ruetze M, Richter W. Adipose-derived stromal cells for osteoarticular repair: trophic function versus stem cell activity. Expert Rev Mol Med. 2014;16:e9. doi: 10.1017/erm.2014.9.
    1. Russo A, Condello V, Madonna V, Guerriero M, Zorzi C. Autologous and micro-fragmented adipose tissue for the treatment of diffuse degenerative knee osteoarthritis. J Exp Orthop. 2017;4(1):33. doi: 10.1186/s40634-017-0108-2.
    1. Saithna A, Kundra R, Getgood A, Spalding T. Opening wedge distal femoral varus osteotomy for lateral compartment osteoarthritis in the valgus knee. Knee. 2014;21(1):172–175. doi: 10.1016/j.knee.2013.08.014.
    1. Sensebé L, Bourin P, Tarte K. Good manufacturing practices production of mesenchymal stem/stromal cells. Hum Gene Ther. 2010;22(1):19–26. doi: 10.1089/hum.2010.197.
    1. Su X, Li C, Liao W, Liu J, Zhang H, Li J, Li Z. Comparison of arthroscopic and conservative treatments for knee osteoarthritis: a 5-year retrospective comparative study. Arthroscopy. 2018;34(3):652–659. doi: 10.1016/j.arthro.2017.09.023.
    1. Verdonk R, Madry H, Shabshin N, Dirisamer F, Peretti GM, Pujol N, Spalding T, Verdonk P, Seil R, Condello V. The role of meniscal tissue in joint protection in early osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2016;24(6):1763–1774. doi: 10.1007/s00167-016-4069-2.

Source: PubMed

3
Iratkozz fel