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

Tongji University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Nonunion Fracture

Treatments: Biological: Human Amniotic Epithelial Cells; Procedure: debridement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03031509

DFSC-2017（CR）-01

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of human amniotic epithelial cells transplant in nonunion of limb fracture patients.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

36 participants in 2 patient groups

hAECs treatment

Experimental group

Description:

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

Treatment:

Procedure: debridement

Biological: Human Amniotic Epithelial Cells

debridement surgery

Sham Comparator group

Description:

debridement surgery

Treatment:

Procedure: debridement