Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative Colitis (AMSC_UC)
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ClinicalTrials.gov Identifier: NCT03609905 |
Recruitment Status :
Recruiting
First Posted : August 1, 2018
Last Update Posted : September 2, 2020
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Condition or disease | Intervention/treatment | Phase |
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Ulcerative Colitis (UC) | Biological: Adipose-cord mesenchymal stromal cells (A-MSCs) Other: Conventional drugs | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase I/II Randomized, Controlled, Clinical Trial for Assessment of the Safety and Efficacy of Allogeneic Adipose Mesenchymal Stem Cells in Moderate to Severe Ulcerative Colitis Patients |
Actual Study Start Date : | July 1, 2018 |
Estimated Primary Completion Date : | June 1, 2021 |
Estimated Study Completion Date : | December 1, 2021 |

Arm | Intervention/treatment |
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Experimental: Intervention group
interventions: The MSCs of 5×10*7 will be given in different sites within colonic submucosa at a total 100 ml with the use of the colonoscope. Once every week,a total of two times. Conventional drug therapy (5-amino-salicylic acid or glucocorticoid) is used
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Biological: Adipose-cord mesenchymal stromal cells (A-MSCs)
A-MSCs 5 x 10~7 diluted on 100 mL of normal saline Other: Conventional drugs 5-amino-salicylic acid or glucocorticoid |
Control group
interventions:Conventional drug therapy (5-amino-salicylic acid or glucocorticoid) is used
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Other: Conventional drugs
5-amino-salicylic acid or glucocorticoid |
- Change From Baseline in Endoscopic Score (as Measured by Ulcerative Colitis Endoscopic Index of Severity) [ Time Frame: Baseline, 8 weeks ]Ulcerative Colitis Endoscopic Index of Severity (UCEIS) is defined as Ulcerative Colitis Endoscopic Index of Severity, with higher scores indicating more severe disease
- Change from Baseline in clinical response (CDAI points) [ Time Frame: Baseline, 8 weeks ]CDAI is defined as Clinical Disease Activity Index
- To evaluate the quality of life index, Short Inflammatory Bowel Disease Questionnaire (SIBDQ) [ Time Frame: Baseline, 8 weeks ]The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a health-related quality of life (HRQoL) tool measuring physical, social, and emotional status. It includes 10-item form of questions. Each question is scored on a Likert scale from 1 (worst) to 7 (best), scores from each item are summed to produce a total score, increased more than 3 scores were considered remission.
- Histologic Evaluation of Ulcerative Colitis [ Time Frame: Baseline, 8 weeks ]A 10 to 20 centimeter (cm) biopsy sample of inflamed mucosal tissue was taken from the worst affected area and scored using the Riley Index. The Riley Index is a histologic scoring system for the assessment of the activity and severity of ulcerative colitis, ranging from 0 to 24. It consists of 6 histologic features (acute inflammatory cell infiltrate, crypt abscesses, mucin depletion, surface epithelial integrity, chronic inflammatory cell infiltrate, and crypt architectural irregularities), all scored on a 4-point scale (higher scores indicate more severe disease).
- Immune response in ulcerative colitis. [ Time Frame: Baseline, 1, 4, 8 weeks ]A number of soluble mediators are detected, including proinflammatory cytokines (TNF, IFN-γ, IL-6.) and anti-inflammatory cytokines (IL-10, IL-4.).
- Incidence of Treatment Adverse. [ Time Frame: Baseline, 1, 4, 8 weeks ]An AE was any untoward medical occurrence in a participant

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female, 18-65 years old
- Diagnosis of ulcerative colitis diagnosed at least 6 months earlier
- Moderate or severe activity defined by a Mayo score
- No serious infection, chronic diseases, diabetes and tuberculosis
- Unefficient by using 5-ASA, glucocorticoid or azathioprine
- Written informed consents were obtained from all subjects
- Capable of good communication with researchers and follow the entire test requirements
- Negative pregnancy test for women of childbearing potential (from menarche to menopause)
Exclusion Criteria:
- Pregnant or breastfeeding women or cognitively impaired adults
- History of malignant disease
- Infectious colitis
- Patients with known allergies to culture medium
- Patients having participated in clinical trials with any investigational drug within 1 month prior to enrolment in this study
- Patients with suspicion of Crohn's enterocolitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated colitis, or microscopic colitis
- Patients with previous colectomy
- Positive to one or more of the infectious disease panel
- Treatment with surgery or biological treatment (infliximab or adamizumab) or Cyclosporine or tacrolimus or mycophenolate in the 8 weeks prior to inclusion in the study
- Presence of severe concomitant diseases
- Patients with clostridium difficult or cytomegalovirus infection

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03609905
Contact: Shaoda Ren, Ph.D. | 86-0635-8272202 | zslrsd@163.com |
China, Shandong | |
Liaocheng city people's hospital | Recruiting |
Liaocheng, Shandong, China, 0635 | |
Contact: Shaoda Ren 86-0635-8272202 zslrsd@163.com |
Study Chair: | Peng Yan, MD | Liaocheng People's Hospital |
Responsible Party: | peng yan, Chief of gastroenterology, Liaocheng People's Hospital |
ClinicalTrials.gov Identifier: | NCT03609905 |
Other Study ID Numbers: |
lcsrmyy-yp1 |
First Posted: | August 1, 2018 Key Record Dates |
Last Update Posted: | September 2, 2020 |
Last Verified: | August 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
ulcerative colitis (UC) mesenchymal stem cells(MSC) |
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |