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

Phase 1

• Conditions: Nonunion Fracture
• Interventions: Biological: Human Amniotic Epithelial Cells; Procedure: debridement

• Registration Number: NCT03031509
• Lead Sponsor: Shanghai East Hospital

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 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.

Study Timeline

• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-25
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-02
• Last Update Posted: 2017-06-05
• Study Start: 2017-12
• Primary Completion: 2018-03
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• diagnosed with nonunion of limbs by x-ray and bone scan;
• compliance to treatment and long term follow-up;
• be able and willing to participate in the study;
• written informed consent before study.

Exclusion Criteria

• pregnant or breastfeeding;
• patients with malignancy, immunocompromised ( HIV AIDS, Diabetes mellitus, active Hepatitis), in a immunosuppressant therapy ( chemotherapy or steroids), OR health status, mental diseases, which will influence the study;
• patients undergoing any other treatment that are not related to this study;
• others considered not appropriate selected patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hAECs treatment	Human Amniotic Epithelial Cells	Human Amniotic Epithelial Cells of 50 million transplant to nonunion site after debridement surgery
hAECs treatment	debridement	Human Amniotic Epithelial Cells of 50 million transplant to nonunion site after debridement surgery
debridement surgery	debridement	debridement surgery

Primary Outcome Measures

Name	Time	Method
time for bone union	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.

Secondary Outcome Measures

Name	Time	Method
pain in fracture site	1 year
limb functional score	1 year

Trial Locations

Locations (1)

Shanghai East Hospital; 🇨🇳 Shanghai, China