A new study at Duke, published in Nature, finds that mesenchymal stem cells (MSCs) offered the same level of benefit as injected corticosteroids to patients with knee osteoarthritis (OA). Conducted at four sites with 480 diverse participants with varying levels of OA severity, the Multicenter Trial of Stem Cell Therapy for Osteoarthritis (MILES) study compared results from MSCs derived from autologous bone marrow aspirate concentrate, autologous stromal vascular fraction, and allogenic human umbilical cord tissue to the gold-standard corticosteroid injection.
Prior survey-based studies found strong indications of benefit from MSC treatments for OA. However, the single-blinded, randomized controlled MILES study showed an equal level of improvement after a year for all three MSC conditions and the corticosteroid injection.
“Physicians can help to create the conditions, but it’s our own bodies that do the work of healing,” says Blake Boggess, DO, principal investigator for the Duke site of the study. “We were hoping that using stem cells would aid in that process, but we were surprised to find that no option was better than the other.”
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Assessing MSCs for OA
Patients were randomly assigned to one of the three MSC conditions or to the corticosteroid injection. The results were assessed in multiple ways, including a self-reported pain score, questionnaire and imaging assessments.
Although a number of prior studies have found corticosteroid injections to benefit for only three months, the MILES study patients that received corticosteroid injections had decreased pain up to one year. Patients receiving MSCs showed a similar benefit with pain scores that also improved across the board. Independent radiologists determined that a year after receiving the treatment some patients’ knees showed improvement on the MRI. These changes will be further investigated in subsequent papers with an extension study that will further characterize MRI changes two and three years after treatment.
The study confirmed that MSCs are a safe treatment with no adverse reactions observed, but MSCs are not the “fountain of youth” they are often portrayed as. “People come in with high hopes based on stem cell centers’ advertising,” Boggess says. “I’ve had patients who’ve been to stem cell centers where they ‘guaranteed’ the patient would never need a knee replacement, and that’s not the case. There’s a conflict of interest when these centers charge high prices for a treatment we now know doesn’t offer marked benefit over corticosteroids.”
Analysis of the study data is ongoing, with three-year results under review, as well as subgroup analysis to determine whether stages of the disease or other demographic factors might correlate with better outcomes for any of the study conditions.
Further research is needed, including isolating anabolic factors in MSCs to further aid in healing.
Providers and patients can feel comfortable knowing that traditional corticosteroid injections offer the same benefits and can be found in outpatient settings to help ease inflammation of the joint while reducing pain.
