Crohn's disease
Conditions
Interventions
MSC combination therapy group:MSCs were injected intravenously and submucosal
Solution control group:Intravenous infusion and submucosal injection of the solvent used to dissolve MSCs
Drug control group:Common drug therapy
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) At the time of randomization, subjects aged between 18 and 75 years; 2) Subjects with at least 3 months of diagnosis of ileal, colonic, or ileal Crohn's disease were recorded when randomized; 3) Having Crohn's disease at present and having a Crohn's disease activity index (CDAI) score >=220 and <=450; 4) Screening for active diseases endoscopic confirmatory examination confirmed the presence of active inflammation and ulcer in the subjects; 5) Subjects must be free from active, latent, or undertreated MYCO bacterium tuberculosis infection; 6) All fertile women and all men must be willing to use at least one effective method of contraception from the time they sign the informed consent form and throughout the study period until 1 month after the last administration of the study drug; 7) Subjects who are willing and able to visit and undergo treatment plans, laboratory tests, and other study procedures from the program; 8) Ability to sign an informed consent (dated) indicating that the subject has been informed of all relevant parts of the study; 9) Subjects receiving nonprohibited combination therapy for any reason must maintain a stable treatment regimen defined as no stem cell treatment or no change in dose 7 days prior to the initial injection of stem cells or 5 half-lives (whichever is longer).
Exclusion criteria
Exclusion criteria: 1) The clinical manifestations are unshaped colitis or ulcerative colitis; 2) CD subjects who underwent an ostomy, gastric or ileum anal pouch, proctocolectomy, or total colectomy, as well as symptomatic stenosis, history of intestinal perforation, suspected abscess, and active drainage fistula; 3) Subjects who have undergone enterectomy in the past 6 months or may require surgery during the study period; 4) Subjects with evidence of pathogenic intestinal infection. Subjects screened for Clostridium difficile or other intestinal infections within 30 days of endoscopy, or subjects screened positive for Clostridium difficile toxin or other pathogens; 5) Screen the subjects with evidence of hematopoietic dysfunction during the visit: - Hemoglobin level=38 degree C at the stage or baseline; 19) Subjects with or with a history of the malignant tumor; 20) Subjects infected with human immunodeficiency virus (HIV) or hepatitis B virus or hepatitis C virus; 21) Subjects considered by the investigator to be uncooperative or unable to comply with study procedures; 22) Any other conditions that the investigator considers would render the subject unfit for inclusion in the study; 23) Prior or present pre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Crohn's Disease Activity Index score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Simplified endoscopy score for Crohn's disease;CRP;Fecal calprotectin levels; | — |
Countries
China
Contacts
Public ContactLan Zhong & Zhongmin Liu
Shanghai East Hospital
Outcome results
None listed