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Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cell Therapy for Rheumatoid Arthritis Patients: A Prospective Phase I/II Study

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Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cell Therapy for Rheumatoid Arthritis Patients: A Prospective Phase I/II Study

Liming Wang et al. Drug Des Devel Ther.

Abstract

Background: The traditional anti-inflammation disease-modifying anti-rheumatic drugs (DMARDs) have limited therapeutic effects in rheumatoid arthritis (RA) patients. We previously reported the safety and efficacy of umbilical cord mesenchymal stem cell (UC-MSC) treatment in RA patients that were observed for up to 8 months after UC-MSC infusion. The aim of this study is to assess the long-term efficacy and safety of UC-MSC along with DMARDs for the treatment of RA.

Methods: 64 RA patients aged 18-64 years were recruited in the study. During the treatment, patients were treated with 40 mL UC-MSC suspension product (2 × 107 cells/20 mL) via intravenous injection immediately after the infusion of 100 mL saline. The serological markers tests were used to assess safety and the 28-joint disease activity score (DAS28) and the Health Assessment Questionnaire (HAQ) to assess efficacy.

Results: 1 year and 3 years after UC-MSC cells treatment, the blood routine, liver and kidney function and immunoglobulin examination showed no abnormalities, which were all in the normal range. The ESR, CRP, RF of 1 year and 3 years after treatment and anti-CCP of 3 years after treatment were detected to be lower than that of pretreatment, which showed significant change (P < 0.05). Health index (HAQ) and joint function index (DAS28) decreased 1 year and 3 years after treatment than before treatment (P < 0.05).

Conclusion: UC-MSC cells plus DMARDs therapy can be a safe, effective and feasible therapeutic option for RA patients.

Keywords: cell therapy; rheumatoid arthritis; umbilical cord mesenchymal stem cell.

Conflict of interest statement

The authors have declared no competing interest.

Figures

Figure 1
Figure 1
Schematic of clinical evaluation for enrolled RA patients treatment by UC-MSC cells.
Figure 2
Figure 2
Routine blood marker changes during different times. TP (A), ALB (B), globulin (C), platelet (D), WB (E) and MCV (F) before treatment and 1-year posttreatment and 3-year posttreatment with umbilical cord mesenchymal stem cells (UC-MSCs) plus disease-modifying anti-rheumatic drugs (DMARDs). Pre-treatment versus after the first or second treatment; * represents P < 0.05, ns represents no significance difference (n = 64).
Figure 3
Figure 3
Live, kidney function and immunoglobulin character of test. BUN (A), cholesterol (B), creatinine (C), hemoglobin (D), blood glucose (E), triglyceride (F) and uric acid (G) before treatment and 1-year posttreatment and 3-year posttreatment with umbilical cord mesenchymal stem cells (UC-MSCs) plus disease-modifying anti-rheumatic drugs (DMARDs). Pre-treatment versus after the first or second treatment, ns represents no significance difference (n = 64).
Figure 4
Figure 4
Long-term stability evaluation of RA patients. ESR (A), RF (B), Anti-CCP (C) and CRP (D), before treatment and 1-year posttreatment and 3-year posttreatment with disease-modifying anti-rheumatic drugs (DMARDs) plus umbilical cord mesenchymal stem cells (UC-MSCs). Pre-treatment versus after the first or second treatment, *** represents P < 0.001, ** represents P < 0.01;1-year posttreatment versus 3-year posttreatment, * represents P < 0.05; ns represents no significance (n = 64).
Figure 5
Figure 5
Scores of DAS28 and HAQ were evaluated after twice of UC-MSCs treatment. (A) DAS28 score was evaluated; (B) HAQ score was evaluated. Pre-treatment versus after the first or second treatment; *** represents P < 0.001, 1-year posttreatment versus 3-year posttreatment; * represents P < 0.05 (n = 64).
Figure 6
Figure 6
A 68 year-male was diagnosed with RA in 1998. In 2010, he was admitted to our hospital for the first time. (A) Shows that his hands could not be kept straight. (B) After 3 years posttreatment, he has stopped using anti-rheumatism medicine for 5 years, and his hands stretch freely and the rheumatic nodules around the joints gradually become soft and fade.
Figure 7
Figure 7
A 33-year female, with 4 years of illness, (A) difficulty in clenching, swelling and pain, morning stiffness, (B) After UC-MSC cells treatment 1 week, the symptoms improved significantly.

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