drugset / Trial / NCT01564407

A Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures

NCT01564407 ↗

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

EvaluationDrugModalityDoseRoute
Subject ICX-RHY-013 Cell therapy 2.5e+06 cells Other
Subject ICX-RHY-013 Cell therapy 5e+06 cells Other