Results of a phase I/II clinical trial for bone marrow derived mesenchymal stromal cells ( MSCs ) were published recently in Stem Cells Translational Medicine, and validate many claims made about MSC stem cells’ ability to heal damaged joints.
Patients with late-stage knee osteoarthritis received a single injection of the knee of either 1, 10, or 50 million bone marrow derived MSCs, in a trial that aimed to establish safety and efficacy of the procedure. The study assessed nearly every aspect of knee arthritis before and after – WOMAC, KOOS, PROMs scores; MRI views of cartilage morphology, collagen content, synovitis markers, inflammation markers, and cartilage turnover markers, all over the period of 12 months.
Most markers of knee joint health showed improvements. The more stem cells that were injected, the better the results were. Generally, the positive effects seemed to be related to the reduction of inflammation and pain, as well as the pausing of arthritis progression.
One positive effect missing was evidence of cartilage regeneration. The researchers suspect the reason for this was that many patients had end-stage arthritis. The patients also were between the ages of 40 to 65. Other researchers using a similar therapeutic technique have seen cartilage regrowth with different subjects. However, the therapy seemed to protect the existing cartilage for at least 12 months afterwards.
Of 50 patients, only 4 experienced an adverse event, which was pain/swelling at the injection site, which subsided without intervention – a typical reaction we see in many stem cell trials.
We at regenerative times are thrilled to see this approach go through a formal clinical trial process, as there has been a lot of misinformation surrounding stem cells’ use in battling arthritis, and even a FDA-led crackdown on clinics using a similar technique, which is currently not approved by the USA’s health regulators. Proving the technique in clinical trials will lead to it being recognized and used as a legitimate therapy for osteoarthritis.
The full paper can be found here: https://stemcellsjournals.onlinelibrary.wiley.com/doi/full/10.1002/sctm.18-0183