Trials / Completed
CompletedNCT03183804
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-201 Clinical Trial
A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 2 Clinical Trial of ALLO-ASC-DFU-201
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 54 (estimated)
- Sponsor
- Anterogen Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-DFU-201) for 23 months.
Detailed description
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-DFU-201) for 23 months. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Diabetic Foot Ulcer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ALLO-ASC-DFU | Application of ALLO-ASC-DFU sheet to diabetic foot ulcer. This study is a follow-up study without intervention. |
| OTHER | Standard therapy | Standard therapy conducted for patients with diabetic foot ulcer. This study is a follow-up study without intervention. |
Timeline
- Start date
- 2015-12-29
- Primary completion
- 2018-08-17
- Completion
- 2018-10-24
- First posted
- 2017-06-12
- Last updated
- 2023-08-25
Locations
4 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03183804. Inclusion in this directory is not an endorsement.