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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nonunion Fracture

Intervention / Treatment
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* Biological: Human Amniotic Epithelial Cells
* Procedure: debridement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hAECs treatment<br>Human Amniotic Epithelial Cells of 50 million transplant to nonunion site after debridement surgery | Biological: Human Amniotic Epithelial Cells<br>* Human Amniotic Epithelial Cells transplant after debridement<br>Procedure: debridement<br>* debridement<br>|
| Sham Comparator: debridement surgery<br>debridement surgery | Procedure: debridement<br>* debridement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time for bone union | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain in fracture site |  | 1 year | 
| limb functional score |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nonunion Fracture of limb