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

Primary Purpose

Nonunion Fracture

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Human Amniotic Epithelial Cells
debridement
Sponsored by
Shanghai East Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonunion Fracture focused on measuring Nonunion Fracture of limb

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai East Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

hAECs treatment

debridement surgery

Arm Description

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

debridement surgery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

pain in fracture site
limb functional score

Full Information

First Posted
January 23, 2017
Last Updated
June 2, 2017
Sponsor
Shanghai East Hospital
Collaborators
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
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1. Study Identification

Unique Protocol Identification Number
NCT03031509
Brief Title
Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells（hAECs）
Official Title
Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells（hAECs）
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2017 (Anticipated)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai East Hospital
Collaborators
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonunion Fracture
Keywords
Nonunion Fracture of limb

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hAECs treatment
Arm Type
Experimental
Arm Description
Human Amniotic Epithelial Cells of 50 million transplant to nonunion site after debridement surgery
Arm Title
debridement surgery
Arm Type
Sham Comparator
Arm Description
debridement surgery
Intervention Type
Biological
Intervention Name(s)
Human Amniotic Epithelial Cells
Intervention Description
Human Amniotic Epithelial Cells transplant after debridement
Intervention Type
Procedure
Intervention Name(s)
debridement
Intervention Description
debridement
Primary Outcome Measure Information:
Title
time for bone union
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
pain in fracture site
Time Frame
1 year
Title
limb functional score
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xia LI, Dr.
Phone
86-21-38804518
Ext
14185
Email
daxia868@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XIA LI, Dr.
Organizational Affiliation
Shanghai East Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai East Hospital
City
Shanghai
ZIP/Postal Code
021
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LIN LI
Phone
86-021-61569006
Ext
9829

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16081662
Citation
Miki T, Lehmann T, Cai H, Stolz DB, Strom SC. Stem cell characteristics of amniotic epithelial cells. Stem Cells. 2005 Nov-Dec;23(10):1549-59. doi: 10.1634/stemcells.2004-0357. Epub 2005 Aug 4.
Results Reference
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PubMed Identifier
25834575
Citation
Si J, Dai J, Zhang J, Liu S, Gu J, Shi J, Shen SG, Guo L. Comparative investigation of human amniotic epithelial cells and mesenchymal stem cells for application in bone tissue engineering. Stem Cells Int. 2015;2015:565732. doi: 10.1155/2015/565732. Epub 2015 Mar 5.
Results Reference
background
PubMed Identifier
25368378
Citation
Jiawen S, Jianjun Z, Jiewen D, Dedong Y, Hongbo Y, Jun S, Xudong W, Shen SG, Lihe G. Osteogenic differentiation of human amniotic epithelial cells and its application in alveolar defect restoration. Stem Cells Transl Med. 2014 Dec;3(12):1504-13. doi: 10.5966/sctm.2014-0118. Epub 2014 Nov 3.
Results Reference
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Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells（hAECs）

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