Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative Colitis
NCT ID: NCT03609905
Last Updated: 2020-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2018-07-01
2021-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Adipose-cord mesenchymal stromal cells (A-MSCs)
A-MSCs 5 x 10\~7 diluted on 100 mL of normal saline
Conventional drugs
5-amino-salicylic acid or glucocorticoid
Control group
interventions:Conventional drug therapy (5-amino-salicylic acid or glucocorticoid) is used
Conventional drugs
5-amino-salicylic acid or glucocorticoid
Interventions
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Adipose-cord mesenchymal stromal cells (A-MSCs)
A-MSCs 5 x 10\~7 diluted on 100 mL of normal saline
Conventional drugs
5-amino-salicylic acid or glucocorticoid
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Liaocheng People's Hospital
OTHER
Responsible Party
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peng yan
Chief of gastroenterology
Principal Investigators
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Peng Yan, MD
Role: STUDY_CHAIR
Liaocheng People's Hospital
Locations
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Liaocheng city people's hospital
Liaocheng, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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lcsrmyy-yp1
Identifier Type: -
Identifier Source: org_study_id
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