Clinical trial NCT03609905: Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative Colitis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Ulcerative Colitis (UC)
Keywords: ulcerative colitis (UC)
mesenchymal stem cells(MSC)
Lead sponsor: Liaocheng People's Hospital
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Endoscopic Score (as Measured by Ulcerative Colitis Endoscopic Index of Severity)
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Change from Baseline in clinical response (CDAI points)
timeFrame: Baseline, 8 weeks
measure: To evaluate the quality of life index, Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
timeFrame: Baseline, 8 weeks
measure: Histologic Evaluation of Ulcerative Colitis
timeFrame: Baseline, 8 weeks
measure: Immune response in ulcerative colitis.
timeFrame: Baseline, 1, 4, 8 weeks
measure: Incidence of Treatment Adverse.
timeFrame: Baseline, 1, 4, 8 weeks
Other outcomes:
Locations:
city: Liaocheng
country: China
facility: Liaocheng city people's hospital
state: Shandong
Study officials:
affiliation: Liaocheng People's Hospital
name: Peng Yan, MD
role: STUDY_CHAIR
References: