Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase III study to evaluate the efficacy and safety of ASC(Autologous Adipose-derived Stem Cells) and Fibringlue or Fibringlue in Patients With Crohn's Fistula.
Experimental: ASC(Autologous Adipose-derived Stem Cells) and Fibringlue, Comparator: Fibringlue, Study type: Interventional, Study design: Randomized
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASC (test arm) | Experimental | (Autologous Adipose-derived Mesenchymal Stem Cells) |
|
| Fibringlue | Placebo Comparator | Standard comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC | Biological | Injection of ASC(Autologous Adipose-derived Mesenchymal Stem Cells) to Crohn's Fistula. The ASC injection dose is about 1x10^7 cells of ASC per 1cm^2 of the surface area of the fistula, and the additional injection dose is 1.5 times the initial injection dose. and up to 30% of the ASC injection dose is administered in combination with Fibringlu. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who are completely blocked fistula | complete blockage | In the 8th week after 1st injection |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who are completely blocked fistula | complete blockage | During 12 months after injection |
| Proportion of subjects who are more than 50% blocked fistula | 50% blockage |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| KyuJoo Park, MD. Ph D | Seoul National University Hospital | Principal Investigator |
| ChangSik Yu, MD. Ph D | Asan Medical Center | Principal Investigator |
| YongBeom Cho, MD. Ph D | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance | Seoul | Seodaemun-gu | 03722 | South Korea | ||
| Seoul Natinoal Univetsity Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Fibringlue | Drug | Injection of Fibringlue to Crohn's Fistula. The Fibringlu injection dose is given the size of the fistula that is fill the entire fistula, and the additional injection dose is the same. |
|
|
| During 12 months after injection |
| Score of evaluation about Investigator satisfaction using questionnaire | Score of evaluation about Investigator satisfaction range from 1 to 5. The lower this score, it means that the higher investigator's satisfaction with treatment effect of investigational product. | In the 8th week, 6th month and 12th month after final injection |
| Proportion of subjects who are confirmed maintenance of fistula blockage by radiology test | Radiology test is performed to subjects who are completely blocked fistula. | Between 6th month and 12th month after final injection |
| Visual improvement effect of perianal fistula wound through photography of it | Visual improvement effect of perianal fistula wound is evaluated by photograph of perianal fistula wound before and after the injection(intervention). | Immediately before and after the injection(intervention) and during 12 months after injection(intervention) |
| Seoul |
| Seoul |
| 03080 |
| South Korea |
| Asan Medical Center | Seoul | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | Seoul | 06351 | South Korea |