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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031509
Recruitment Status : Unknown
Verified June 2017 by Shanghai East Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 25, 2017
Last Update Posted : June 5, 2017
Sponsor:
Collaborator:
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Information provided by (Responsible Party):
Shanghai East Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nonunion Fracture Biological: Human Amniotic Epithelial Cells Procedure: debridement Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells（hAECs）
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arms and Interventions
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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
debridement surgery
 Procedure: debridement
debridement


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. pain in fracture site [ Time Frame: 1 year ]
  2. limb functional score [ Time Frame: 1 year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031509


Contacts
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Contact: Xia LI, Dr. 86-21-38804518 ext 14185 daxia868@163.com

Locations
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China
Shanghai East Hospital
Shanghai, China, 021
Contact: LIN LI    86-021-61569006 ext 9829      
Sponsors and Collaborators
Shanghai East Hospital
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Investigators
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Principal Investigator: XIA LI, Dr. Shanghai East Hospital
More Information
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Publications:

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Responsible Party: Shanghai East Hospital
ClinicalTrials.gov Identifier: NCT03031509    
Other Study ID Numbers: DFSC-2017（CR）-01
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai East Hospital:
Nonunion Fracture of limb
Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Ununited
Wounds and Injuries