期刊
STEM CELL RESEARCH & THERAPY
卷 12, 期 1, 页码 -出版社
BMC
DOI: 10.1186/s13287-021-02417-3
关键词
Mesenchymal stromal cells; Type 1 diabetes; Transplantation; beta cell function
资金
- National Key Research and Development Program of China [2017YFC1309605]
- Nanjing Health Youth Talent [QRX17123]
- Jiangsu Provincial Key Medical Discipline [ZDXKB2016012]
The study demonstrated that one repeated intravenous dose of allogeneic UC-MSCs is safe in people with recent-onset T1D and may result in better islet beta cell preservation during the first year after diagnosis compared to standard treatment alone. The MSC-treated group showed a significantly higher rate of achieving clinical remission compared to the control arm, with some individuals even achieving insulin independence. Multivariable logistic regression analysis showed that lower fasting C-peptide and higher dose of UC-MSC correlated with the achievement of clinical remission after transplantation, with no severe side effects observed.
Background: The preservation or restoration of beta cell function in type 1 diabetes (T1D) remains as an attractive and challengeable therapeutic target. Mesenchymal stromal cells (MSCs) are multipotent cells with high capacity of immunoregulation, which emerged as a promising cell-based therapy for many immune disorders. The objective of this study was to examine the efficacy and safety of one repeated transplantation of allogeneic MSCs in individuals with T1D. Methods: This was a nonrandomized, open-label, parallel-armed prospective study. MSCs were isolated from umbilical cord (UC) of healthy donors. Fifty-three participants including 33 adult-onset (>= 18 years) and 20 juvenile-onset T1D were enrolled. Twenty-seven subjects (MSC-treated group) received an initial systemic infusion of allogeneic UC-MSCs, followed by a repeat course at 3 months, whereas the control group (n = 26) only received standard care based on intensive insulin therapy. Data at 1-year follow-up was reported in this study. The primary endpoint was clinical remission defined as a 10% increase from baseline in the level of fasting and/or postprandial C-peptide. The secondary endpoints included side effects, serum levels of HbA1c, changes in fasting and postprandial C-peptide, and daily insulin doses. Results: After 1-year follow-up, 40.7% subjects in MSC-treated group achieved the primary endpoint, significantly higher than that in the control arm. Three subjects in MSC-treated group, in contrast to none in control group, achieved insulin independence and maintained insulin free for 3 to 12 months. Among the adult-onset T1D, the percent change of postprandial C-peptide was significantly increased in MSC-treated group than in the control group. However, changes in fasting or postprandial C-peptide were not significantly different between groups among the juvenile-onset T1D. Multivariable logistic regression assay indicated that lower fasting C-peptide and higher dose of UC-MSC correlated with achievement of clinical remission after transplantation. No severe side effects were observed. Conclusion: One repeated intravenous dose of allogeneic UC-MSCs is safe in people with recent-onset T1D and may result in better islet beta cell preservation during the first year after diagnosis compared to standard treatment alone.
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