There are four distinct possible outcomes that ACBIs can deliver for the complex disease of osteoarthritis. Any of these or all would significantly reduce the health burden of the disease on the Australian community.

Osteoarthritis

ACBIs for joint disease and injury is routinely used in the veterinary industry to modify disease outcomes in companion animals and horses. Veterinarians have used autologous SVF to treat tendon and ligament injuries and joint disease in horses on a commercial basis since 2003  in the USA [1,2] and recently in Australia (2007). A summary of the animal literature can be found in the review by Perdisa et al (2015).

There is a body evidence in the literature that supports the use of ACBIs for knee osteoarthritis (Table 1 and 2). A total 5,336 patients have been treated safely and effectively for knee and hip disease within 44 scientific publications. The longest period being 11 years.

Within these publications there are 6 Level II studies and 4 level III studies which evidence over 20 publications with 1,628 patients for SVF derived cells; and 22 publications for 3,708 patients for bone-marrow derived cells.

A NHMRC-Body-of-Evidence-Matrix can be downloaded here.

Clinical Evidence of knee and hip joints treated by ACBIs

Table 1: Publication list of knee and hip joints treated by autologous SVF and ASCs (updated 6th July 2016)

A total of 20 SVF refereed publications with 1,638 patients for Knee and Hip disease with 2 Level II studies and 3 Level III studies. See references at bottom of this page.

Adipose SVF Publications for Knee and Hip diseases

SVF Pub 1-12SVF Pub 13-20Autologous Adipose ASC* Publications for Knee and Hip diseasesSVFPub21-22

 

SVF – autologous stromal vascular fraction, HA – Hyaluronic acid, FG – fibrin glue, PRP – platelet rich plasma.

*ASC – Adipose mesenchymal stem cells which have been grown and cultured from adipose tissue

 Table 2: Publication list of knee and hip joints treated by bone marrow-derived cells in knee and hip joints (updated 6th July 2016)

A total of 22 publications with 3,708 patients treated (with 4 Level II studies, and 2 Level III studies).

BM1-6BM7-17BM18-22A-MSC – Autologous cultured mesenchymal cells, PBMC – peripheral blood monocytes, BMC – Autologous non-cultured bone marrow concentrate cells.

References – Publications – Adipose SVF & Autologous Adipose ASC* Publications for Knee and Hip diseases [Table 1]

  1. Gibbs, N., et al., Management of knee osteoarthritis by combined stromal vascular fraction cell therapy, platelet-rich plasma, and musculoskeletal exercises: a case series. J Pain Res, 2015. 8: p. 799-806.
  2. Kim, Y.S., et al., Assessment of clinical and MRI outcomes after mesenchymal stem cell implantation in patients with knee osteoarthritis: a prospective study. Osteoarthritis Cartilage, 2016. 24(2): p. 237-45.
  3. Kim, Y.S., et al., Comparative Matched-Pair Analysis of the Injection Versus Implantation of Mesenchymal Stem Cells for Knee Osteoarthritis. Am J Sports Med, 2015. 43(11): p. 2738-46.
  4. Koh, Y.G., et al., Adipose-Derived Mesenchymal Stem Cells With Microfracture Versus Microfracture Alone: 2-Year Follow-up of a Prospective Randomized Trial. Arthroscopy, 2016. 32(1): p. 97-109.
  5. Garza, J., et al., Use of autologous adipose-derived stromal vascular fraction to treat osteoarthritis of the knee: A feasibility and safety study. J Regen Med, 2015. 4: p. 1-6.
  6. Kim, Y.S., Y.J. Choi, and Y.G. Koh, Mesenchymal Stem Cell Implantation in Knee Osteoarthritis: An Assessment of the Factors Influencing Clinical Outcomes. Am J Sports Med, 2015.
  7. Fodor, P.B. and S.G. Paulseth, Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint. Aesthet Surg J, 2015.
  8. Michalek, J., et al., Stem Cell Therapy of Osteoarthritis Using Stromal Vascular Fraction Cells – Proceeding of the STEMSO Conference. CellR4, 2014. 2(1).
  9. Bui, K.H.-T., et al., Symptomatic knee osteoarthritis treatment using autologous adipose derived stem cells and platelet-rich plasma: a clinical study. Biomedical Research and Therapy, 2014. 1(1).
  10. Pak, J., J.H. Lee, and S.H. Lee, Regenerative repair of damaged meniscus with autologous adipose tissue-derived stem cells. Biomed Res Int, 2014. 2014: p. 436029.
  11. Koh, Y.G., et al., Comparative outcomes of open-wedge high tibial osteotomy with platelet-rich plasma alone or in combination with mesenchymal stem cell treatment: a prospective study. Arthroscopy, 2014. 30(11): p. 1453-60.
  12. Koh, Y.G., et al., Second-Look Arthroscopic Evaluation of Cartilage Lesions After Mesenchymal Stem Cell Implantation in Osteoarthritic Knees. Am J Sports Med, 2014. 42(7): p. 1628-37.
  13. Koh, Y.G., et al., Clinical results and second-look arthroscopic findings after treatment with adipose-derived stem cells for knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc, 2013. 23(5): p. 1308-16.
  14. Koh, Y.G., et al., Mesenchymal stem cell injections improve symptoms of knee osteoarthritis. Arthroscopy, 2013. 29(4): p. 748-55.
  15. Pak, J., et al., Safety reporting on implantation of autologous adipose tissue-derived stem cells with platelet-rich plasma into human articular joints. BMC Musculoskelet Disord, 2013. 14: p. 337.
  16. Pak, J., J.H. Lee, and S.H. Lee, A novel biological approach to treat chondromalacia patellae. PLoS One, 2013. 8(5): p. e64569.
  17. Koh, Y.G. and Y.J. Choi, Infrapatellar fat pad-derived mesenchymal stem cell therapy for knee osteoarthritis. Knee, 2012. 19(6): p. 902-7.
  18. Pak, J., Autologous adipose tissue-derived stem cells induce persistent bone-like tissue in osteonecrotic femoral heads. Pain Physician, 2012. 15(1): p. 75-85.
  19. Pak, J., Regeneration of human bones in hip osteonecrosis and human cartilage in knee osteoarthritis with autologous adipose-tissue-derived stem cells: a case series. J Med Case Rep, 2011. 5: p. 296.
  20. Bright, R., Adipose derived stromal cells to treat joint disease. J Cosmetic Surgery & Medicine, 2010. 5(3).
  21. Pers, Y.M., et al., Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial. Stem Cells Transl Med, 2016. 5(7): p. 847-56.
  22. Jo, C.H., et al., Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: a proof-of-concept clinical trial. Stem Cells, 2014. 32(5): p. 1254-66.

References –  Publications – Autologous Bone Marrow-Derived Cells [Table 2]

  1. Centeno, C.J., et al., A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions. Int Orthop, 2016.
  2. Soler, R., et al., Final results of a phase I-II trial using ex vivo expanded autologous Mesenchymal Stromal Cells for the treatment of osteoarthritis of the knee confirming safety and suggesting cartilage regeneration. Knee, 2016.
  3. Gobbi, A., et al., Matrix-Induced Autologous Chondrocyte Implantation versus Multipotent Stem Cells for the Treatment of Large Patellofemoral Chondral Lesions: A Nonrandomized Prospective Trial. Cartilage, 2015. 6(2): p. 82-97.
  4. Yamasaki, S., et al., Cartilage Repair With Autologous Bone Marrow Mesenchymal Stem Cell Transplantation: Review of Preclinical and Clinical Studies. Cartilage, 2014. 5(4): p. 196-202.
  5. Vangsness, C.T., Jr., et al., Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study. J Bone Joint Surg Am, 2014. 96(2): p. 90-8.
  6. 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.
  7. Gobbi, A., G. Karnatzikos, and S.R. Sankineani, One-step surgery with multipotent stem cells for the treatment of large full-thickness chondral defects of the knee. Am J Sports Med, 2014. 42(3): p. 648-57.
  8. Orozco, L., et al., Treatment of knee osteoarthritis with autologous mesenchymal stem cells: a pilot study. Transplantation, 2013. 95(12): p. 1535-41.
  9. Saw, K.Y., et al., Articular cartilage regeneration with autologous peripheral blood progenitor cells and hyaluronic acid after arthroscopic subchondral drilling: a report of 5 cases with histology. Arthroscopy, 2011. 27(4): p. 493-506.
  10. Kasemkijwattana, C., et al., Autologous bone marrow mesenchymal stem cells implantation for cartilage defects: two cases report. J Med Assoc Thai, 2011. 94(3): p. 395-400.
  11. Davatchi, F., et al., Mesenchymal stem cell therapy for knee osteoarthritis. Preliminary report of four patients. Int J Rheum Dis, 2011. 14(2): p. 211-5.
  12. Nejadnik, H., et al., Autologous bone marrow-derived mesenchymal stem cells versus autologous chondrocyte implantation: an observational cohort study. Am J Sports Med, 2010. 38(6): p. 1110-6.
  13. Haleem, A.M., et al., The Clinical Use of Human Culture-Expanded Autologous Bone Marrow Mesenchymal Stem Cells Transplanted on Platelet-Rich Fibrin Glue in the Treatment of Articular Cartilage Defects: A Pilot Study and Preliminary Results. Cartilage, 2010. 1(4): p. 253-261.
  14. Centeno, C.J., et al., Safety and complications reporting on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther, 2010. 5(1): p. 81-93.
  15. Wakitani, S., et al., Safety of autologous bone marrow-derived mesenchymal stem cell transplantation for cartilage repair in 41 patients with 45 joints followed for up to 11 years and 5 months. J Tissue Eng Regen Med, 2011. 5(2): p. 146-50.
  16. Centeno, C.J., et al., Regeneration of meniscus cartilage in a knee treated with percutaneously implanted autologous mesenchymal stem cells. Med Hypotheses, 2008. 71(6): p. 900-8.
  17. Centeno, C.J., et al., Increased knee cartilage volume in degenerative joint disease using percutaneously implanted, autologous mesenchymal stem cells. Pain Physician, 2008. 11(3): p. 343-53.
  18. Kuroda, R., et al., Treatment of a full-thickness articular cartilage defect in the femoral condyle of an athlete with autologous bone-marrow stromal cells. Osteoarthritis Cartilage, 2007. 15(2): p. 226-31.
  19. Centeno, C.J., et al., Partial regeneration of the human hip via autologous bone marrow nucleated cell transfer: A case study. Pain Physician, 2006. 9(3): p. 253-6.
  20. Wakitani, S., et al., Repair of articular cartilage defects in the patello-femoral joint with autologous bone marrow mesenchymal cell transplantation: three case reports involving nine defects in five knees. J Tissue Eng Regen Med, 2007. 1(1): p. 74-9.
  21. Wakitani, S., et al., Autologous bone marrow stromal cell transplantation for repair of full-thickness articular cartilage defects in human patellae: two case reports. Cell Transplant, 2004. 13(5): p. 595-600.
  22. Wakitani, S., et al., Human autologous culture expanded bone marrow mesenchymal cell transplantation for repair of cartilage defects in osteoarthritic knees. Osteoarthritis Cartilage, 2002. 10(3): p. 199-206.