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

June 2, 2017 updated by: Shanghai East Hospital
The purpose of this study is to evaluate the efficacy and safety of human amniotic epithelial cells transplant in nonunion of limb fracture patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 021
        • Shanghai East Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
pain in fracture site
Time Frame: 1 year
1 year
limb functional score
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai East Hospital

Collaborators

Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

Investigators

  • Principal Investigator: XIA LI, Dr., Shanghai East Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2017

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

January 23, 2017

First Submitted That Met QC Criteria

January 23, 2017

First Posted (Estimate)

January 25, 2017

Study Record Updates

Last Update Posted (Actual)

June 5, 2017

Last Update Submitted That Met QC Criteria

June 2, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFSC-2017（CR）-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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