Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03609905
• Date of registration: 01/06/2018
• Prospective Registration: Yes
• Primary sponsor: Liaocheng People's Hospital
• Public title: Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative Colitis AMSC_UC
• Scientific 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
• Date of first enrolment: July 1, 2018
• Target sample size: 50
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03609905
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

China

Contacts

• Name: Shaoda Ren

• Name: Shaoda Ren, Ph.D.

• Name: Peng Yan, MD
• Affiliation: Liaocheng People's Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis (UC)

Intervention(s)

Other: Conventional drugs

Biological: Adipose-cord mesenchymal stromal cells (A-MSCs)

Primary Outcome(s)

Change From Baseline in Endoscopic Score (as Measured by Ulcerative Colitis Endoscopic Index of Severity) [Time Frame: Baseline, 8 weeks]

Secondary Outcome(s)

Change from Baseline in clinical response (CDAI points) [Time Frame: Baseline, 8 weeks]

Immune response in ulcerative colitis. [Time Frame: Baseline, 1, 4, 8 weeks]

To evaluate the quality of life index, Short Inflammatory Bowel Disease Questionnaire (SIBDQ) [Time Frame: Baseline, 8 weeks]

Histologic Evaluation of Ulcerative Colitis [Time Frame: Baseline, 8 weeks]

Incidence of Treatment Adverse. [Time Frame: Baseline, 1, 4, 8 weeks]

Secondary ID(s)

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Source(s) of Monetary Support

Please refer to primary and secondary sponsors