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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031509
Recruitment Status : 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

Tracking Information
First Submitted Date  ICMJE January 23, 2017
First Posted Date  ICMJE January 25, 2017
Last Update Posted Date June 5, 2017
Estimated Study Start Date  ICMJE December 2017
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
  • pain in fracture site [ Time Frame: 1 year ]
  • limb functional score [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells(hAECs)
Official Title  ICMJE Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells(hAECs)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nonunion Fracture
Intervention  ICMJE
  • Biological: Human Amniotic Epithelial Cells
    Human Amniotic Epithelial Cells transplant after debridement
  • Procedure: debridement
    debridement
Study Arms  ICMJE
  • Experimental: hAECs treatment
    Human Amniotic Epithelial Cells of 50 million transplant to nonunion site after debridement surgery
    Interventions:
    • Biological: Human Amniotic Epithelial Cells
    • Procedure: debridement
  • Sham Comparator: debridement surgery
    debridement surgery
    Intervention: Procedure: debridement
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2017)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xia LI, Dr. 86-21-38804518 ext 14185 daxia868@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03031509
Other Study ID Numbers  ICMJE DFSC-2017(CR)-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Shanghai East Hospital
Study Sponsor  ICMJE Shanghai East Hospital
Collaborators  ICMJE Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Investigators  ICMJE
Principal Investigator: XIA LI, Dr. Shanghai East Hospital
PRS Account Shanghai East Hospital
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP