Intra-Articular Knee Implantation of Autologous Bone Marrow–Derived Mesenchymal Stromal Cells in Rheumatoid Arthritis Patients with Knee Involvement: Results of A Randomized, Triple-Blind, Placebo-Controlled Phase ۱/۲ Clinical Trial

Background: In this study, we intend to assess the safety andtolerability of intra-articular knee implantation of autologousbone marrow–derived mesenchymal stromal cells (MSCs) inpatients with rheumatoid arthritis (RA) and to determine thepreliminary clinical efficacy data in this population. The trialregistration numbers are as follows: Royan Institute EthicsCommittee: AC/۹۱/۱۱۳۳; NCT۰۱۸۷۳۶۲۵.Materials and Methods: This single-center, randomized,triple-blind, placebo-controlled phase۱/۲ clinical trial randomizedRA patients with knee involvement to receive either anintra-articular knee implantation of ۴۰ million autologous bonemarrow–derived MSCs per joint or normal saline (placebo).Patients were followed up for ۱۲ months to assess therapy outcomes.Results: A total of ۳۰ patients, ۱۵ in the MSC group and ۱۵ inthe placebo group, enrolled in this study. There were no adverseeffects reported after MSC administration or during follow-up.Patients who received MSCs had superior findings according tothe Western Ontario and McMaster Universities Arthritis Index(WOMAC), visual analogue scale (VAS), time to jelling andpain-free walking distance. However, this improvement couldnot be significantly sustained beyond ۱۲ months. The MSCgroup exhibited improved standing time (P = ۰.۰۱). In addition,the MSCs appeared to contribute to reductions in methotrexateand prednisolone use.Conclusion: Intra-articular knee implantation of MSCs appearedto be safe and well tolerated. In addition, we observeda trend toward clinical efficacy. These results, in our opinion,have justified the need for further investigations over an ex-tended assessment period with larger numbers of RA patientswho have knee involvement.

کلیدواژه ها:

Bone Marrow ، Mesenchymal Stromal Cells ، Osteoarthritis ، Rheumatoid Arthritis