Crohn's Disease, Fistula
Conditions
Keywords
Crohn's fistula, Autologous adipose derived stem cell
Brief summary
This is an open follow-up clinical trials to evaluate a sustained efficacy and safety of Adipoplus inj. for 10 months (12 months after final dose injection)after Phase II clinical trial.
Interventions
None listed
Sponsors
Anterogen Co., Ltd.
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* the patients who have participated in ANTG-ASC-202 clinical trial * the patients who have experienced with Adipoplus in ANTG-ASC-202 trials * the patients who submit written consents and is able to obey requirements of trials
Exclusion criteria
* pregnant or breast feeding * autoimmune disease other than Crohn's disease * infectious diseases including HBV, HCV or HIV * who is not willing to use effective contraceptive methods during the study. * active tuberculosis * moderate to severe active or worsened Crohn's disease * who have received Infliximab during or after ANTG-ASC-202 trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with Sustained efficacy of complete closure of fistula | Month 4, 10 | Proportion of patients whose fistula has been completely closed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with sustained efficacy of closure of fistula | Month 2, 4, 10 | Proportion of patients with more than 50% closed of fistula (Month 2, 4, 10) |
| Number of patients with any adverse event | Month 2, 4, 10 | number of patients with any adverse event (Month 2, 4, 10) |
| Grade of Investigator's satisfaction | Month 2, 4, 10 | Grade of Investigator's satisfaction (Month 2, 4, 10) 1. very satisfaction 2. satisfacttion 3. somewhat satisfaction 4. unsatisfaction 5. very unsatisfaction |
Countries
South Korea
Outcome results
None listed