Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 65 Years|
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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 1/Phase 2|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Liaocheng People's Hospital|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Peng Yan, MD|
|Principal Investigator Affiliation||Liaocheng People's Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Ulcerative Colitis (UC)|
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
Other: Control group
interventions:Conventional drug therapy (5-amino-salicylic acid or glucocorticoid) is used
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
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.