Help us: Donate
Follow us on:



Human Trial Success for Osteoarthritis Stem Cell Therapy


The results of a clinical trial using bone marrow-derived mesenchymal stromal cells (MSCs) to treat late-stage knee osteoarthritis were published recently, and they came back positive. The trial included both phase 1 and 2 and was designed to determine the safety and efficacy of MSC stem cell therapy.

A battery of tests

During the trial, patients were given a single injection of 1, 10, or 50 million MSCs directly into the knee. The trial used a number of tests associated with knee osteoarthritis, including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a common set of standardized questionnaires used by healthcare professionals to evaluate the condition of patients with osteoarthritis of the knee. The WOMAC includes questions relating to pain, stiffness, and the physical functioning of the joints.

The trial also used the Knee Injury and Osteoarthritis Outcome Score (KOOS), which was developed as an extension of the WOMAC as a means of evaluating short-term and long-term symptoms and function.

Patient-reported outcome measures (PROMs), which measure the outcomes of procedures from the patient’s perspective, were also part of the trial. Patients complete questionnaires both before the procedure and 3-6 months after it. This helps to assess the longer-term outcome for patients and informs future therapeutic direction.

The study also used various biomarkers typically associated with the condition, including MRI scans for changes to cartilage, collagen levels, synovitis biomarkers, inflammatory biomarkers, and cartilage turnover rate. All of these markers were taken over a 12-month period.

Positive results from a single injection

The majority of these markers showed some level of improvement, and those improvements scaled with the amount of MSCs injected, with the larger doses giving better results. The researchers observed that the beneficial effects were associated with a reduction of inflammation and pain as well as a slowing down of osteoarthritis progression. This is consistent with other studies which show that MSCs have an anti-inflammatory effect on tissues, and the data supports the hypothesis that MSC stem cells facilitate the healing of damaged joints through the various factors that they secrete

There was no evidence of cartilage regeneration in these patients; the researchers believe that this was because the patients in this study had end-stage osteoarthritis and were aged between 40 and 65. In other studies, researchers have reported seeing cartilage regeneration, though this may have been because the patients were either younger or at less advanced stages of the disease. On the plus side, the therapy did appear to protect the existing cartilage for at least a 12-month period following the therapy.

The therapy was well tolerated, with only four of the patients experiencing an adverse effect, which was pain and swelling at the site of injection. This minor side effect subsided by itself, did not require any intervention, and is a typical reaction seen in various stem cell trials.


Patients with late‐stage Kellgren‐Lawrence knee osteoarthritis received a single intra‐articular injection of 1, 10, or 50 million bone marrow mesenchymal stromal cells (BM‐MSCs) in a phase I/IIa trial to assess safety and efficacy using a broad toolset of analytical methods. Besides safety, outcomes included patient‐reported outcome measures (PROMs): Knee Injury and Osteoarthritis Outcome Score (KOOS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC); contrast‐enhanced magnetic resonance imaging (MRI) for cartilage morphology (Whole Organ MRI Scores [WORMS]), collagen content (T2 scores), and synovitis; and inflammation and cartilage turnover biomarkers, all over 12 months. BM‐MSCs were characterized by a panel of anti‐inflammatory markers to predict clinical efficacy. There were no serious adverse events, although four patients had minor, transient adverse events. There were significant overall improvements in KOOS pain, symptoms, quality of life, and WOMAC stiffness relative to baseline; the 50 million dose achieved clinically relevant improvements across most PROMs. WORMS and T2 scores did not change relative to baseline. However, cartilage catabolic biomarkers and MRI synovitis were significantly lower at higher doses. Pro‐inflammatory monocytes/macrophages and interleukin 12 levels decreased in the synovial fluid after MSC injection. The panel of BM‐MSC anti‐inflammatory markers was strongly predictive of PROMs over 12 months. Autologous BM‐MSCs are safe and result in significant improvements in PROMs at 12 months. Our analytical tools provide important insights into BM‐MSC dosing and BM‐MSC reduction of synovial inflammation and cartilage degradation and provide a highly predictive donor selection criterion that will be critical in translating MSC therapy for osteoarthritis.


This is a positive result for stem cell therapy, and it is great to see a successful clinical trial demonstrating the benefits of MSC therapy. In the current climate of FDA crackdowns on rogue clinics selling dubious and untested stem cell therapies, it is good to see things being done properly, passing through clinical trials, and delivering positive results for osteoarthritis patients. Hopefully, these results will encourage health regulators to move forwards in approving this therapy in the United States for the treatment of osteoarthritis.

Please connect with us on social media, like and share our content, and help us build grass-roots support for healthy life extension: YouTube Facebook Twitter Instagram Instagram Discord
Thank You!

About the author

Steve Hill

Steve serves on the LEAF Board of Directors and is the Editor in Chief, coordinating the daily news articles and social media content of the organization. He is an active journalist in the aging research and biotechnology field and has to date written over 600 articles on the topic, interviewed over 100 of the leading researchers in the field, hosted livestream events focused on aging, as well as attending various medical industry conferences. His work has been featured in H+ magazine, Psychology Today, Singularity Weblog, Standpoint Magazine, Swiss Monthly, Keep me Prime, and New Economy Magazine. Steve is one of three recipients of the 2020 H+ Innovator Award and shares this honour with Mirko Ranieri – Google AR and Dinorah Delfin – Immortalists Magazine. The H+ Innovator Award looks into our community and acknowledges ideas and projects that encourage social change, achieve scientific accomplishments, technological advances, philosophical and intellectual visions, author unique narratives, build fascinating artistic ventures, and develop products that bridge gaps and help us to achieve transhumanist goals. Steve has a background in project management and administration which has helped him to build a united team for effective fundraising and content creation, while his additional knowledge of biology and statistical data analysis allows him to carefully assess and coordinate the scientific groups involved in the project.
  1. June 26, 2019

    It is very exciting to see positive growth in the field of regenerative medicine.

    We completely agree with you in regards to the importance of proper regulation.

    As a Stem Cell Therapy clinic ourselves we believe one of our biggest assets is that we are highly regulated by the Cayman Islands government.

  2. November 29, 2019

    Has there been any independent study using stem cells from Wharton’s Jelly used by Vitilaity Health clinics? This is not covered by insurance and it should be.

  3. drdavidgreenemd
    June 5, 2020

    Thank you for sharing the information and now individuals don’t have to go through painful joint replacement surgeries, when a shot of stem cells can cure the damaged cartilage.

  4. appl314
    June 13, 2020

    I am looking forward to the continued research in this area. Lack of mobility of individuals, in my opinion, is the condition that contributes the most to the decline of quality of life and of lifespan of humans. Since it is prevalent (common place) and not immediately life threatening it is not giving the funding necessary to find solutions, however, it has a large impact to our national medical budget due to the secondary conditions resulting from the reduced mobility (IE: diabetes, heart, obesity, etc..

  5. hooverrichard37
    November 15, 2020

    Thanks for sharing this important information! Hope this method will be soon widespread and affordable for all arthritis sufferers!

Write a comment:


Your email address will not be published.

This site uses Akismet to reduce spam. Learn how your comment data is processed.