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:1. Age 18-65 years old, male or female; 2. refractory CD fistula, there are 1-2 and 1-3 in the mouth fistula; 3. Diagnostic CD at least three months; 4. CDAI <250; 5. were receiving drug treatment (5-ASA and hormones> 4 weeks, immunosuppressants and biological agents> 8 weeks); 6. signed informed consent.
Exclusion Criteria:1. with intestinal obstruction, stenosis, or perianal abscess; 2. pregnant or lactating women; 3. infection needs antibiotics persons; 4. rectovaginal fistula; 5. complex anal fistula more than two inside the mouth; 6. stenosis or perforation CD; 7. perianal infection; 8. could not do rectal or anal stenosis local injection therapy; 9. with acute enteritis; 10. , liver and kidney dysfunction; 11. a month have used other drugs are in clinical trials; 12. no conditions or unwilling to carry out MRI inspected; 13. who are adjusting therapy; 14. HIV patients; 15. The combined active hepatitis or tuberculosis; Occurred in 16) 6 months opportunistic infections, or severe infections occur within three months; 17) In the past five years, those who suffer from cancer; 18) there is a history of lymphoproliferative disease.
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 2/Phase 3|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Sixth Affiliated Hospital, Sun Yat-sen University|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Crohn's Disease, Fistula|
Peri-anal fistula is common seen in Crohn's disease. Treatments including surgery, antibiotics, immunosuppressive drug and infliximab improve the quality of life of the patients suffering Crohn's perianal fistula, but the recurrent rate is still high. MSC showed promising effect in the therapy of CD, but the standard treatment strategy is unclear. Here investigators will carry out this phase II clinical trial to explore a effective therapeutic regimen of MSC in the Crohn's perianal fistula.
Patient in this arm will receive routine surgery and local MSC injection of 3×10E6/kg
Patient in this arm will receive routine surgery and local MSC injection of 6×10E6/kg
Patient in this arm will receive routine surgery and local NS injection
Procedure: - Routine drainage surgery
Biological: - MSC injection 01
Local MSC injection in peri-anal with a dose of 3×10E6/kg
Biological: - MSC injection 02
Local MSC injection in peri-anal with a dose of 6×10E6/kg
Other: - placebo
NS injection instead of MSC
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
For additional contact information, you can also visit the trial on clinicaltrials.gov.