drugset / Trial / NCT01564407
A Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures
Phase 1/2
Terminated
15 enrolled
University of Pittsburgh
United States Department of Defense · collab
RandomizedParallel-groupOpen-labelBasic science
Summary
The primary objective of this study is to evaluate the safety of ICX-RHY-013 in the treatment of stable, restrictive scars in subjects who have suffered a burn injury. Evaluation will be achieved through regular assessment of adverse events, vital signs, blood work monitoring and laboratory analysis cellular properties of the scar through biopsy. The secondary objectives of this study are to evaluate improvement in symptoms of scars including reduced pain, discomfort and itching, improvement in mobility and daily function, improvement in appearance and scar texture.
Timeline
- Start
- 2011-01
- Primary completion
- 2014-02
- Completion
- 2014-02
Outcome
Outcome not reported
Stopped (Business): “Study Terminated due to lack of Funding”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ICX-RHY-013 | Cell therapy | 2.5e+06 cells | Other |
| Subject | ICX-RHY-013 | Cell therapy | 5e+06 cells | Other |