PSC Knee Osteoarthritis Stem Cell Research Results
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.
Common Questions
Once banked through our StemReady™ program, your stem cells are cryopreserved and securely stored, ready for use when you and your physician decide. While not all therapies are commercially available yet, you may qualify for programs like the FDA's compassionate use or the Federal Right-to-Try Act if you have a life-threatening or debilitating condition.
Ask our team how you may qualify.
The cost of our services at Personalized Stem Cells varies depending on the specific treatment plan and stem cell banking options you choose.
Here are the general starting points for PSC services:
- StemPreserve: Starting at $2,500 plus an annual banking fee.
- StemReady: Prices begin at $12,500, which includes preparation of cells for immediate use.
These are your initial costs and do not include any additional fees that your doctor may charge to perform the lipoaspiration or treatment. For a detailed breakdown and to discuss payment options, please contact our customer service team. We're committed to providing transparent and comprehensive pricing information.
Getting started with stem cell banking at PSC is easy. Simply schedule a consultation through our website or contact our team directly. We’ll guide you through the entire process, from the initial collection of your cells to their long-term storage, ensuring you have all the information you need to make an informed decision. Schedule a consultation here.
PSC’s cell therapies are currently being investigated through formal FDA clinical trials with leading scientists and institutions. PSC has completed its first safety and efficacy study and submitted the findings to the FDA. Until formal FDA approval is obtained, PSC cannot make specific claims about this therapy. However, our initial safety and efficacy study is available upon request and has been published in a peer-reviewed journal.
PSC adheres to stringent FDA guidelines to guarantee the safety and quality of your stored stem cells. Our state-of-the-art lab utilizes advanced processing techniques to ensure that your cells are preserved at the highest standards. Every batch of stem cells is tested for sterility and purity.
