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Randomized Controlled Trial
. 2021 Jun 9;6(1):217.
doi: 10.1038/s41392-021-00607-2.

Human umbilical cord mesenchymal stem cell transfusion in immune non-responders with AIDS: a multicenter randomized controlled trial

Lifeng Wang #  1 , Zheng Zhang #  2 , Ruonan Xu #  1 , Xicheng Wang #  3 , Zhanjun Shu  4 , Xiejie Chen  5 , Siyu Wang  1 , Jiaye Liu  1 , Yuanyuan Li  1 , Li Wang  3 , Mi Zhang  3 , Wei Yang  4 , Ying Wang  4 , Huihuang Huang  1 , Bo Tu  1 , Zhiwei Liang  5 , Linghua Li  5 , Jingxin Li  6 , Yuying Hou  1 , Ming Shi  1 , Fu-Sheng Wang  7
Affiliations
Randomized Controlled Trial

Human umbilical cord mesenchymal stem cell transfusion in immune non-responders with AIDS: a multicenter randomized controlled trial

Lifeng Wang et al. Signal Transduct Target Ther. .

Abstract

We examined the safety and efficacy of human umbilical cord mesenchymal stem cell (hUC-MSC) infusion for immune non-responder (INR) patients with chronic HIV-1 infection, who represent an unmet medical need even in the era of efficient antiretroviral therapy (ART). Seventy-two INR patients with HIV were enrolled in this phase II randomized, double-blinded, multicenter, placebo-controlled, dose-determination trial (NCT01213186) from May 2013 to March 2016. They were assigned to receive high-dose (1.5 × 106/kg body weight) or low-dose (0.5 × 106/kg body weight) hUC-MSC, or placebo. Their clinical and immunological parameters were monitored during the 96-week follow-up study. We found that hUC-MSC treatment was safe and well-tolerated. Compared with baseline, there was a statistical increase in CD4+ T counts in the high-dose (P < 0.001) and low-dose (P < 0.001) groups after 48-week treatment, but no change was observed in the control group. Kaplan-Meier analysis revealed a higher cumulative probability of achieving an immunological response in the low-dose group compared with the control group (95.8% vs. 70.8%, P = 0.004). However, no significant changes in CD4/CD8+ T counts and CD4/CD8 ratios were observed among the three groups. In summary, hUC-MSC treatment is safe. However, the therapeutic efficacy of hUC-MSC treatment to improve the immune reconstitution in INR patients still needs to be further investigated in a large cohort study.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Study design. a Graphic overview of the study schedule; and b CONSORT (Consolidated Standards of Reporting Trials) diagram
Fig. 2
Fig. 2
Longitudinal changes of peripheral CD4 counts, CD8 counts, and CD4/CD8 ratios according to treatment group. a CD4 counts; b CD8 counts; c CD4/CD8 ratios. *P < 0.05; **P < 0.01
Fig. 3
Fig. 3
The cumulative probability of patients with an immunological response. Analyses of the cumulative probability of patients whose CD4 counts increased > 30% (a) or (b) >100 cells/μL compared with baseline
See this image and copyright information in PMC

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