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Cytotherapy. 2018 Apr;20(4):499-506. doi: 10.1016/j.jcyt.2017.12.009. Epub 2018 Feb 7.

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 1/2 clinical trial.

Author information

1
Rheumatology Department, Baqiyatallah Hospital, Baqiyatallah University of Medical Sciences, Tehran, Iran.
2
Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, Iranian Academic Center for Education, Culture and Research (ACECR), Tehran, Iran.
3
Department of Epidemiology and Reproductive Health, Reproductive Epidemiology Research Center, Royan Institute for Reproductive Biomedicine, Iranian Academic Center for Education, Culture and Research (ACECR), Tehran, Iran.
4
Department of Reproductive Imaging, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, Iranian Academic Center for Education, Culture and Research (ACECR), Tehran, Iran.
5
Rheumatology Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: rrclab@tums.ac.ir.
6
Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, Iranian Academic Center for Education, Culture and Research (ACECR), Tehran, Iran. Electronic address: Nasser.Aghdami@royaninstitute.org.

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.

KEYWORDS:

bone marrow; mesenchymal stromal cells; osteoarthritis; rheumatoid arthritis

PMID:
29428486
DOI:
10.1016/j.jcyt.2017.12.009

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