Abstract
Background
In this study, we intend to assess the safety and tolerability of intra-articular
knee implantation of autologous bone marrow–derived mesenchymal stromal cells (MSCs)
in patients with rheumatoid arthritis (RA) and to determine the preliminary clinical
efficacy data in this population. The trial registration numbers are as follows: Royan
Institute Ethics Committee: AC/91/1133; NCT01873625.
Methods
This single-center, randomized, triple-blind, placebo-controlled phase 1/2 clinical
trial randomized RA patients with knee involvement to receive either an intra-articular
knee implantation of 40 million autologous bone marrow–derived MSCs per joint or normal
saline (placebo). Patients were followed up for 12 months to assess therapy outcomes.
Results
A total of 30 patients, 15 in the MSC group and 15 in the placebo group, enrolled
in this study. There were no adverse effects reported after MSC administration or
during follow-up. Patients who received MSCs had superior findings according to the
Western Ontario and McMaster Universities Arthritis Index (WOMAC), visual analogue
scale (VAS), time to jelling and pain-free walking distance. However, this improvement
could not be significantly sustained beyond 12 months. The MSC group exhibited improved
standing time (P = 0.01). In addition, the MSCs appeared to contribute to reductions in methotrexate
and prednisolone use.
Conclusion
Intra-articular knee implantation of MSCs appeared to be safe and well tolerated.
In addition, we observed a trend toward clinical efficacy. These results, in our opinion,
have justified the need for further investigations over an extended assessment period
with larger numbers of RA patients who have knee involvement.
Key Words
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Article info
Publication history
Published online: February 07, 2018
Accepted:
December 27,
2017
Received:
June 17,
2017
Identification
Copyright
© 2018 Published by Elsevier Inc. on behalf of International Society for Cellular Therapy.
