Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative Colitis
AMSC_UC
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
1 other identifier
interventional
50
1 country
1
Brief Summary
Ulcerative colitis is a form of inflammatory bowel disease characterized by diffuse inflammation of the colonic mucosa. It affects the rectum and extends proximally along a variable length of the colon. Ulcerative colitis is a chronic condition with a relapsing remitting course. Mesenchymal stem cells (MSCs) are a subset of adult stem cells residing in many tissues, including bone marrow (BM), adipose tissue, umbilical cord blood. Recent experimental findings have shown the ability of MSCs to home to damaged tissues and to produce paracrine factors with anti-inflammatory properties, potentially resulting in reduction of inflammation and functional recovery of the damaged tissues. The purpose of our study is to evaluate safety and efficacy of the intracolonic injection by using a colonoscope of allogeneic adipose MSCs in patients with moderate active ulcerative colitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2018
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2018
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedFirst Posted
Study publicly available on registry
August 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedSeptember 2, 2020
August 1, 2020
2.9 years
June 1, 2018
August 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Endoscopic Score (as Measured by Ulcerative Colitis Endoscopic Index of Severity)
Ulcerative Colitis Endoscopic Index of Severity (UCEIS) is defined as Ulcerative Colitis Endoscopic Index of Severity, with higher scores indicating more severe disease
Baseline, 8 weeks
Secondary Outcomes (5)
Change from Baseline in clinical response (CDAI points)
Baseline, 8 weeks
To evaluate the quality of life index, Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Baseline, 8 weeks
Histologic Evaluation of Ulcerative Colitis
Baseline, 8 weeks
Immune response in ulcerative colitis.
Baseline, 1, 4, 8 weeks
Incidence of Treatment Adverse.
Baseline, 1, 4, 8 weeks
Study Arms (2)
Intervention group
EXPERIMENTALinterventions: 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
Control group
OTHERinterventions:Conventional drug therapy (5-amino-salicylic acid or glucocorticoid) is used
Interventions
A-MSCs 5 x 10\~7 diluted on 100 mL of normal saline
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- Presence of severe concomitant diseases
- Patients with clostridium difficult or cytomegalovirus infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Liaocheng city people's hospital
Liaocheng, Shandong, 0635, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Peng Yan, MD
Liaocheng People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of gastroenterology
Study Record Dates
First Submitted
June 1, 2018
First Posted
August 1, 2018
Study Start
July 1, 2018
Primary Completion
June 1, 2021
Study Completion
December 1, 2021
Last Updated
September 2, 2020
Record last verified: 2020-08