Trials / Active Not Recruiting
Active Not RecruitingNCT04612465
Clinical Study to Evaluate Efficacy and Safety of ASC and Fibringlue or Fibringlue in Patients With Crohn's Fistula
Phase 3 Clinical Study to Evaluate Efficacy and Safety of ASC(Autologous Adipose-derived Stem Cells) and Fibringlue or Fibringlue in Patients With Crohn's Fistula.: A Randomized Study
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Anterogen Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
Experimental: ASC(Autologous Adipose-derived Stem Cells) and Fibringlue, Comparator: Fibringlue, Study type: Interventional, Study design: Randomized
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ASC | 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. |
| DRUG | Fibringlue | 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. |
Timeline
- Start date
- 2020-01-09
- Primary completion
- 2025-04-08
- Completion
- 2025-09-23
- First posted
- 2020-11-03
- Last updated
- 2025-09-29
Locations
4 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04612465. Inclusion in this directory is not an endorsement.