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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-31

Study Completion Date

2020-12-31

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.

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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.

Conditions

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Nonunion Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hAECs treatment

Human Amniotic Epithelial Cells of 50 million transplant to nonunion site after debridement surgery

Group Type EXPERIMENTAL

Human Amniotic Epithelial Cells

Intervention Type BIOLOGICAL

Human Amniotic Epithelial Cells transplant after debridement

debridement

Intervention Type PROCEDURE

debridement

debridement surgery

Group Type SHAM_COMPARATOR

debridement

Intervention Type PROCEDURE

debridement

Interventions

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Human Amniotic Epithelial Cells

Human Amniotic Epithelial Cells transplant after debridement

Intervention Type BIOLOGICAL

debridement

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No