Autologous adipose-derived stem cells for the treatment of Crohn’s fistula-in-ano: an open-label, controlled trial
Abstract Background Crohn’s fistula-in-ano is a refractory disease in colorectal and anal surgery. Although autologous adipose-derived stem cell (ADSC) has been used in the treatment of Crohn’s fistula-in-ano because of its convenience, non-incision of normal tissue, good tolerance, repeatability, q...
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| Format: | Article |
| Language: | English |
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BMC
2020-03-01
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| Series: | Stem Cell Research & Therapy |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13287-020-01636-4 |
| _version_ | 1818296944136552448 |
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| author | Chungen Zhou Meng Li Yang Zhang Min Ni Yehuang Wang Dachao Xu Yang Shi Bo Zhang Yanni Chen Yan Huang Sumin Zhang Hongzhen Shi Bin Jiang |
| author_facet | Chungen Zhou Meng Li Yang Zhang Min Ni Yehuang Wang Dachao Xu Yang Shi Bo Zhang Yanni Chen Yan Huang Sumin Zhang Hongzhen Shi Bin Jiang |
| author_sort | Chungen Zhou |
| collection | DOAJ |
| description | Abstract Background Crohn’s fistula-in-ano is a refractory disease in colorectal and anal surgery. Although autologous adipose-derived stem cell (ADSC) has been used in the treatment of Crohn’s fistula-in-ano because of its convenience, non-incision of normal tissue, good tolerance, repeatability, quick recovery, less pain, less damage to anal function, and high quality of life during the perioperative period, there are no reports of its use in China. This is the first clinical trial in China on the treatment of Crohn’s fistula-in-ano with ADSC to evaluate its efficacy and safety. Methods A total of 22 patients with Crohn’s fistula-in-ano were enrolled in this study from January 2018 to October 2018 in the Colorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine. Patients were divided (1:1) into an observation group (ADSC) and a control group (incision-thread-drawing procedure). Primary efficacy endpoint evaluated at months 3, 6, and 12 was the closure of fistulas (closure of all treated fistulas at baseline, confirmed by doctor’s clinical assessment and magnetic resonance imaging or transrectal ultrasonography). The patients additionally completed some scoring scales at each follow-up including simplified Crohn’s Disease Activity Index (CDAI), Perianal Disease Activity Index (PDAI), Inflammatory Bowel Disease Questionnaire (IBDQ), pain scores with visual analog score (VAS), and Wexner score. The data of inflammatory indexes were also collected. Results The healing rates of the observation group and the control group at months 3, 6, and 12 were as follows: 10/11(90.9%) vs 5/11(45.5%), 8/11(72.7%) vs 6/11(54.5%), and 7/11(63.6%) vs 6/11(54.5%), respectively. There was no statistical difference between the two groups. In addition, the improvement in simplified CDAI, PDAI, IBDQ, VAS, and Wexner score of the observation group were better than that of the control group at each follow-up. The inflammatory indexes decreased in both the observation group and the control group at 3 months follow-up. And there were no significant differences in the changes of inflammatory indexes between two groups at month 3 compared with the baseline. Safety was maintained throughout month 12, and adverse events occurred in 63.6% of patients in the observation group and 100% patients in the control group. And no adverse event associated with ADSC injection was observed in the study. Conclusion ADSC is a feasible and effective treatment for Crohn’s fistula-in-ano, compared with traditional incision and thread-drawing. It can protect anal function of patients, relieve pain, allow quick recovery, be well-tolerated, and improve the quality of life during perioperative period. Trial registration China Clinical Trials Registry, No. ChiCTR1800014599. Registered 23 January 2018. |
| first_indexed | 2024-12-13T04:11:35Z |
| format | Article |
| id | doaj.art-29dad51e43fe41d195ad63e2033864ce |
| institution | Directory Open Access Journal |
| issn | 1757-6512 |
| language | English |
| last_indexed | 2024-12-13T04:11:35Z |
| publishDate | 2020-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Stem Cell Research & Therapy |
| spelling | doaj.art-29dad51e43fe41d195ad63e2033864ce2022-12-22T00:00:03ZengBMCStem Cell Research & Therapy1757-65122020-03-0111111310.1186/s13287-020-01636-4Autologous adipose-derived stem cells for the treatment of Crohn’s fistula-in-ano: an open-label, controlled trialChungen Zhou0Meng Li1Yang Zhang2Min Ni3Yehuang Wang4Dachao Xu5Yang Shi6Bo Zhang7Yanni Chen8Yan Huang9Sumin Zhang10Hongzhen Shi11Bin Jiang12Graduate School of Nanjing University of Chinese MedicineColorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese MedicineColorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese MedicineColorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese MedicineColorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese MedicineColorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese MedicineReaserch Institute of Jiangsu Decon Bio-science Technologies Company Ltd.Zhongda Hospital Southeast UniversityZhongda Hospital Southeast UniversityYale School of Engineering & Applied ScienceColorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese MedicineReaserch Institute of Jiangsu Decon Bio-science Technologies Company Ltd.Colorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese MedicineAbstract Background Crohn’s fistula-in-ano is a refractory disease in colorectal and anal surgery. Although autologous adipose-derived stem cell (ADSC) has been used in the treatment of Crohn’s fistula-in-ano because of its convenience, non-incision of normal tissue, good tolerance, repeatability, quick recovery, less pain, less damage to anal function, and high quality of life during the perioperative period, there are no reports of its use in China. This is the first clinical trial in China on the treatment of Crohn’s fistula-in-ano with ADSC to evaluate its efficacy and safety. Methods A total of 22 patients with Crohn’s fistula-in-ano were enrolled in this study from January 2018 to October 2018 in the Colorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine. Patients were divided (1:1) into an observation group (ADSC) and a control group (incision-thread-drawing procedure). Primary efficacy endpoint evaluated at months 3, 6, and 12 was the closure of fistulas (closure of all treated fistulas at baseline, confirmed by doctor’s clinical assessment and magnetic resonance imaging or transrectal ultrasonography). The patients additionally completed some scoring scales at each follow-up including simplified Crohn’s Disease Activity Index (CDAI), Perianal Disease Activity Index (PDAI), Inflammatory Bowel Disease Questionnaire (IBDQ), pain scores with visual analog score (VAS), and Wexner score. The data of inflammatory indexes were also collected. Results The healing rates of the observation group and the control group at months 3, 6, and 12 were as follows: 10/11(90.9%) vs 5/11(45.5%), 8/11(72.7%) vs 6/11(54.5%), and 7/11(63.6%) vs 6/11(54.5%), respectively. There was no statistical difference between the two groups. In addition, the improvement in simplified CDAI, PDAI, IBDQ, VAS, and Wexner score of the observation group were better than that of the control group at each follow-up. The inflammatory indexes decreased in both the observation group and the control group at 3 months follow-up. And there were no significant differences in the changes of inflammatory indexes between two groups at month 3 compared with the baseline. Safety was maintained throughout month 12, and adverse events occurred in 63.6% of patients in the observation group and 100% patients in the control group. And no adverse event associated with ADSC injection was observed in the study. Conclusion ADSC is a feasible and effective treatment for Crohn’s fistula-in-ano, compared with traditional incision and thread-drawing. It can protect anal function of patients, relieve pain, allow quick recovery, be well-tolerated, and improve the quality of life during perioperative period. Trial registration China Clinical Trials Registry, No. ChiCTR1800014599. Registered 23 January 2018.http://link.springer.com/article/10.1186/s13287-020-01636-4Autologous adipose-derived stem cellsStem cell transplantationCrohn’s fistula-in-anoEfficacySafety |
| spellingShingle | Chungen Zhou Meng Li Yang Zhang Min Ni Yehuang Wang Dachao Xu Yang Shi Bo Zhang Yanni Chen Yan Huang Sumin Zhang Hongzhen Shi Bin Jiang Autologous adipose-derived stem cells for the treatment of Crohn’s fistula-in-ano: an open-label, controlled trial Stem Cell Research & Therapy Autologous adipose-derived stem cells Stem cell transplantation Crohn’s fistula-in-ano Efficacy Safety |
| title | Autologous adipose-derived stem cells for the treatment of Crohn’s fistula-in-ano: an open-label, controlled trial |
| title_full | Autologous adipose-derived stem cells for the treatment of Crohn’s fistula-in-ano: an open-label, controlled trial |
| title_fullStr | Autologous adipose-derived stem cells for the treatment of Crohn’s fistula-in-ano: an open-label, controlled trial |
| title_full_unstemmed | Autologous adipose-derived stem cells for the treatment of Crohn’s fistula-in-ano: an open-label, controlled trial |
| title_short | Autologous adipose-derived stem cells for the treatment of Crohn’s fistula-in-ano: an open-label, controlled trial |
| title_sort | autologous adipose derived stem cells for the treatment of crohn s fistula in ano an open label controlled trial |
| topic | Autologous adipose-derived stem cells Stem cell transplantation Crohn’s fistula-in-ano Efficacy Safety |
| url | http://link.springer.com/article/10.1186/s13287-020-01636-4 |
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