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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03031509

Enrollment

Registered

2017-01-25

Start date

2017-12-31

Completion date

2020-12-31

Last updated

2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonunion Fracture

Keywords

Nonunion Fracture of limb

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.

Interventions

BIOLOGICALHuman Amniotic Epithelial Cells

Human Amniotic Epithelial Cells transplant after debridement

PROCEDUREdebridement

debridement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
time for bone union	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

Measure	Time frame
pain in fracture site	1 year
limb functional score	1 year

Countries

China

Contacts

Primary ContactXia LI, Dr.

daxia868@163.com86-21-38804518

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026