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To evaluate the safety and efficacy of hUC-MSCs-Exos in the treatment of ulcerative colitis.
Full description
A large number of previous studies and literature data collection have demonstrated the efficacy of hUC-MSCs-Exos in animal models of inflammatory bowel disease, so the investigators will further verify the safety and effectiveness of hUC-MSCs-Exos in the treatment of UC patients, and provide new ideas for clinical treatment of UC.
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
Diagnosis of CD or undefined colitis (IBD- undefined) or other types of colitis or enteritis that may confuse assessment of effectiveness.
The current diagnosis is explosive colitis and/or toxic megacolon.
Had received fecal microbial transplantation within 4 weeks prior to randomization.
Had been hospitalized for UC within 2 weeks prior to screening.
There is clear evidence of past or current low or high grade colon dysplasia, including dysplasia detected during screening colonoscopy that has not been completely resectable.
Have any active or severe infection that does not resolve after adequate treatment.
Hepatitis B, hepatitis C virus infection, tuberculosis, HIV, uncontrollable diabetes, mental illness.
Have undergone organ transplantation requiring sustained immunosuppressive therapy.
A history of cancer within the past 5 years (except for completely treated non-melanoma skin cell carcinoma or carcinoma in situ of the cervix after complete surgical removal). Subjects who have had a diagnostic evaluation that suggests malignancy (e.g., chest or breast imaging) and who cannot reasonably rule out malignancy after additional clinical evaluation will be excluded from this study.
A history of drug or alcohol abuse in the 6 months prior to screening (as reported by the subject).
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups, including a placebo group
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Central trial contact
Lan Zhong
Data sourced from clinicaltrials.gov
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