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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Shanghai East Hospital

Current Primary Outcome: time for bone union [ Time Frame: 6 months ]

Bone union was evaluated at 6-month after surgery according to the following definition.Definition of bone union is when simple X-ray findings reveal that bone trabeculae or cortical bone exceeds the fracture site.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • pain in fracture site [ Time Frame: 1 year ]
  • limb functional score [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: Shanghai East Hospital

Dates:
Date Received: January 23, 2017
Date Started: March 2017
Date Completion: December 2020
Last Updated: February 5, 2017
Last Verified: January 2017