Human umbilical cord mesenchymal stem cell transfusion in immune non-responders with AIDS: a multicenter randomized controlled trial
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...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Nature Publishing Group
2021-06-01
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| Series: | Signal Transduction and Targeted Therapy |
| Online Access: | https://doi.org/10.1038/s41392-021-00607-2 |
| _version_ | 1818670999922540544 |
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| author | Lifeng Wang Zheng Zhang Ruonan Xu Xicheng Wang Zhanjun Shu Xiejie Chen Siyu Wang Jiaye Liu Yuanyuan Li Li Wang Mi Zhang Wei Yang Ying Wang Huihuang Huang Bo Tu Zhiwei Liang Linghua Li Jingxin Li Yuying Hou Ming Shi Fu-Sheng Wang |
| author_facet | Lifeng Wang Zheng Zhang Ruonan Xu Xicheng Wang Zhanjun Shu Xiejie Chen Siyu Wang Jiaye Liu Yuanyuan Li Li Wang Mi Zhang Wei Yang Ying Wang Huihuang Huang Bo Tu Zhiwei Liang Linghua Li Jingxin Li Yuying Hou Ming Shi Fu-Sheng Wang |
| author_sort | Lifeng Wang |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-17T07:17:02Z |
| format | Article |
| id | doaj.art-3e920619a7f74dadbce84613fe745402 |
| institution | Directory Open Access Journal |
| issn | 2059-3635 |
| language | English |
| last_indexed | 2024-12-17T07:17:02Z |
| publishDate | 2021-06-01 |
| publisher | Nature Publishing Group |
| record_format | Article |
| series | Signal Transduction and Targeted Therapy |
| spelling | doaj.art-3e920619a7f74dadbce84613fe7454022022-12-21T21:58:51ZengNature Publishing GroupSignal Transduction and Targeted Therapy2059-36352021-06-01611810.1038/s41392-021-00607-2Human umbilical cord mesenchymal stem cell transfusion in immune non-responders with AIDS: a multicenter randomized controlled trialLifeng Wang0Zheng Zhang1Ruonan Xu2Xicheng Wang3Zhanjun Shu4Xiejie Chen5Siyu Wang6Jiaye Liu7Yuanyuan Li8Li Wang9Mi Zhang10Wei Yang11Ying Wang12Huihuang Huang13Bo Tu14Zhiwei Liang15Linghua Li16Jingxin Li17Yuying Hou18Ming Shi19Fu-Sheng Wang20Treatment and Research Center for Infectious Diseases, Fifth Medical Center of Chinese PLA General HospitalInstitute of Hepatology, National Clinical Research Center for Infectious Disease, Shenzhen Third People’s Hospital, The Second Affiliated Hospital, School of Medicine, Southern University of Science and TechnologyTreatment and Research Center for Infectious Diseases, Fifth Medical Center of Chinese PLA General HospitalYunnan Provincial Hospital of Infectious DiseasesXinjiang Uygur Autonomous Regional the Sixth People’s HospitalGuangzhou Eighth People’s Hospital, Guangzhou Medical UniversityTreatment and Research Center for Infectious Diseases, Fifth Medical Center of Chinese PLA General HospitalTreatment and Research Center for Infectious Diseases, Fifth Medical Center of Chinese PLA General HospitalTreatment and Research Center for Infectious Diseases, Fifth Medical Center of Chinese PLA General HospitalYunnan Provincial Hospital of Infectious DiseasesYunnan Provincial Hospital of Infectious DiseasesXinjiang Uygur Autonomous Regional the Sixth People’s HospitalXinjiang Uygur Autonomous Regional the Sixth People’s HospitalTreatment and Research Center for Infectious Diseases, Fifth Medical Center of Chinese PLA General HospitalTreatment and Research Center for Infectious Diseases, Fifth Medical Center of Chinese PLA General HospitalGuangzhou Eighth People’s Hospital, Guangzhou Medical UniversityGuangzhou Eighth People’s Hospital, Guangzhou Medical UniversityNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and PreventionTreatment and Research Center for Infectious Diseases, Fifth Medical Center of Chinese PLA General HospitalTreatment and Research Center for Infectious Diseases, Fifth Medical Center of Chinese PLA General HospitalTreatment and Research Center for Infectious Diseases, Fifth Medical Center of Chinese PLA General HospitalAbstract 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.https://doi.org/10.1038/s41392-021-00607-2 |
| spellingShingle | Lifeng Wang Zheng Zhang Ruonan Xu Xicheng Wang Zhanjun Shu Xiejie Chen Siyu Wang Jiaye Liu Yuanyuan Li Li Wang Mi Zhang Wei Yang Ying Wang Huihuang Huang Bo Tu Zhiwei Liang Linghua Li Jingxin Li Yuying Hou Ming Shi Fu-Sheng Wang Human umbilical cord mesenchymal stem cell transfusion in immune non-responders with AIDS: a multicenter randomized controlled trial Signal Transduction and Targeted Therapy |
| title | Human umbilical cord mesenchymal stem cell transfusion in immune non-responders with AIDS: a multicenter randomized controlled trial |
| title_full | Human umbilical cord mesenchymal stem cell transfusion in immune non-responders with AIDS: a multicenter randomized controlled trial |
| title_fullStr | Human umbilical cord mesenchymal stem cell transfusion in immune non-responders with AIDS: a multicenter randomized controlled trial |
| title_full_unstemmed | Human umbilical cord mesenchymal stem cell transfusion in immune non-responders with AIDS: a multicenter randomized controlled trial |
| title_short | Human umbilical cord mesenchymal stem cell transfusion in immune non-responders with AIDS: a multicenter randomized controlled trial |
| title_sort | human umbilical cord mesenchymal stem cell transfusion in immune non responders with aids a multicenter randomized controlled trial |
| url | https://doi.org/10.1038/s41392-021-00607-2 |
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