NCT03031509

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 5, 2017

Status Verified

June 1, 2017

Enrollment Period

3 months

First QC Date

January 23, 2017

Last Update Submit

June 2, 2017

Conditions

Nonunion Fracture

Keywords

Nonunion Fracture of limb

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (2)

  • pain in fracture site

    1 year

  • limb functional score

    1 year

Study Arms (2)

hAECs treatment

EXPERIMENTAL

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

Biological: Human Amniotic Epithelial CellsProcedure: debridement

debridement surgery

SHAM COMPARATOR

debridement surgery

Procedure: debridement

Interventions

Human Amniotic Epithelial CellsBIOLOGICAL

Human Amniotic Epithelial Cells transplant after debridement

hAECs treatment
debridementPROCEDURE

debridement

debridement surgeryhAECs treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai East Hospital

Shanghai, 021, China

Location

Related Publications (3)

  • 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.

    PMID: 16081662BACKGROUND

  • 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.

    PMID: 25834575BACKGROUND

  • 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.

    PMID: 25368378BACKGROUND

MeSH Terms

Conditions

Fractures, Ununited

Interventions

Debridement

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • XIA LI, Dr.

    Shanghai East Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xia LI, Dr.

CONTACT

86-21-38804518daxia868@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2017

First Posted

January 25, 2017

Study Start

December 1, 2017

Primary Completion

March 1, 2018

Study Completion

December 1, 2020

Last Updated

June 5, 2017

Record last verified: 2017-06

Locations

CN(1)