Stem cell therapy has the potential to treat a wide range of medical conditions giving hope to many patients who are in search of better treatment options. Millions of Americans are enduring the agony of knee osteoarthritis that remains unyielding to conventional conservative care. These patients need a safe and effective alternative treatment that can provide long lasting relief without surgery.
Stem cell therapy using a patient’s own adipose (fat) tissue for knee osteoarthritis has attracted researchers and physicians because of the simple, safe and comfortable harvesting method used to obtain these cells. This highly effective method allows the collection of millions of stem cells through a mini-lipoaspiration procedure. Bone marrow, umbilical cord and other tissues do contain stem cells, but adipose tissue has been shown to be the richest source of these regenerative cells.
Although bone marrow was the first tissue source of stem cells studied in knee osteoarthritis, adipose-derived stem cells (ASC) have been shown to be superior. [1-3] Several published scientific papers have reported on the safety and effectiveness of ASC therapy for knee arthritis, as well as their ability to regenerate articular cartilage. [3-5] And, contrary to popular belief, an older patient’s own adipose-derived stem cells are more effective for the treatment of knee osteoarthritis than young umbilical cord-derived stem cells. [6-8]
Personalized Stem Cells (PSC) has completed the first ever FDA-approved clinical trial of GMP lab manufactured ASCs for patients with knee osteoarthritis. The FDA approved the study based upon the strong safety data obtained from more than 20,000 animal patients treated by PSC’s parent company, VetStem.
In this study, 29 patients with an average age of 65 years and moderate to severe knee osteoarthritis consented to receive a single injection of their own adipose-derived stem cells. These patients had daily knee pain and had failed the typical non-surgical therapies including steroid injections, hyaluronic gel injections, oral medication, and physical therapy.
All patients underwent a simple mini-lipoaspiration procedure to collect the adipose tissue. From this sample, the investigational stem cell product known as stromal vascular fraction (SVF) was manufactured in an FDA-inspected lab in San Diego. The product was tested for purity, potency, and sterility before being released back to the patient’s physician. Each patient received a single SVF knee joint injection using ultrasound vision guidance and was monitored for safety and efficacy for a mean follow-up of 2.6 years.
The procedure was well tolerated with no serious safety issues identified. Mild adverse events such as pain and swelling typical for a knee injection did occur in some patients, but all of these resolved without the need for ongoing treatment. Although most patients had been advised to consider total joint replacement surgery by their surgeon, 23 of the 29 patients were able to avoid surgery at 2.6 years follow-up. Interestingly, 83% of the patients who did undergo surgery indicated that they were satisfied with the stem cell treatment and would have preferred to have a repeat stem cell injection, rather than undergo surgery. Unfortunately, this was not an option at the time.
Patients reported significant improvements in their daily function, pain level, symptoms, sports activities, and quality of life. Nearly 75% of the patients had a significant improvement in their pain and function as early as 3 months after treatment. These benefits persisted out to an average follow-up of 2.6 years. At that time point, 77% of the patients were satisfied with the treatment and 78% were able to avoid joint replacement surgery.
From this study, we have demonstrated preliminary safety at these dose levels for PSC’s adipose-derived stem cell therapy for knee osteoarthritis with long term benefits. Based on MRI findings, other clinical trials have shown that ASC therapy can improve the knee cartilage health up to 5 years. [9]
Growing evidence suggests that repeating the treatment over years can help many patients avoid surgery and allow them to maintain an active and pain-free lifestyle. PSC will be conducting additional clinical studies in the very near future to broaden our understanding of stem cell therapy and the benefits it can offer.
References
- Han, X., et al., Clinical therapeutic efficacy of mesenchymal stem cells derived from adipose or bone marrow for knee osteoarthritis: a meta-analysis of randomized controlled trials. J Comp Eff Res, 2020. 9(5): p. 361-374.
- Muthu, S., et al., Comparative effectiveness of adipose-derived mesenchymal stromal cells in the management of knee osteoarthritis: A meta-analysis. World J Orthop, 2023. 14(1): p. 23-41.
- Kim, K.I., M.S. Kim, and J.H. Kim, Intra-articular Injection of Autologous Adipose-Derived Stem Cells or Stromal Vascular Fractions: Are They Effective for Patients With Knee Osteoarthritis? A Systematic Review With Meta-analysis of Randomized Controlled Trials. Am J Sports Med, 2023. 51(3): p. 837-848.
- Yang, Y., et al., Effect of intra-knee injection of autologous adipose stem cells or mesenchymal vascular components on short-term outcomes in patients with knee osteoarthritis: an updated meta-analysis of randomized controlled trials. Arthritis Res Ther, 2023. 25(1): p. 147.
- Huang, Z., et al., What is the optimal dose of adipose-derived mesenchymal stem cells treatment for knee osteoarthritis? A conventional and network meta-analysis of randomized controlled trials. Stem Cell Res Ther, 2023. 14(1): p. 245.
- Ju, Y., et al., Comparison of biological characteristics of human adipose- and umbilical cord- derived mesenchymal stem cells and their effects on delaying the progression of osteoarthritis in a rat model. Acta Histochem, 2022. 124(6): p. 151911.
- Hsu, C.C., et al., Shockwave Therapy Combined with Autologous Adipose-Derived Mesenchymal Stem Cells Is Better than with Human Umbilical Cord Wharton’s Jelly-Derived Mesenchymal Stem Cells on Knee Osteoarthritis. Int J Mol Sci, 2020. 21(4).
- Wang, J., et al., Mesenchymal stem cells – a promising strategy for treating knee osteoarthritis. Bone Joint Res, 2020. 9(10): p. 719-728.
- Kim, K.I., et al., Safety and Efficacy of the Intra-articular Injection of Mesenchymal Stem Cells for the Treatment of Osteoarthritic Knee: A 5-Year Follow-up Study. Stem Cells Transl Med, 2022. 11(6): p. 586-596.