NCT03031509

Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells（hAECs）

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Shanghai East Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of human amniotic epithelial cells transplant in nonunion of limb fracture patients.

Detailed description

In this study, patients of nonunion after limb fracture will be treated with human amniotic epithelial cells. Clinical and radiological assessment is performed. hAECs developing from the epiblast as early as 8 days after fertilization, recent data reported indicate that hAECs possess proper osteogenic differentiation potential and a localized modulatory influence on the early tissue remodeling process, making these cells a promising stem cell source for bone regeneration after fractures.

Conditions

• Nonunion Fracture

Interventions

Type	Name	Description
BIOLOGICAL	Human Amniotic Epithelial Cells	Human Amniotic Epithelial Cells transplant after debridement
PROCEDURE	debridement	debridement

Timeline

• Start date: 2017-12-01
• Primary completion: 2018-03-01
• Completion: 2020-12-01
• First posted: 2017-01-25
• Last updated: 2017-06-05

Locations

1 site across 1 country: China