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

Nonunion Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03031509
• Other study ID #: DFSC-2017(CR)-01
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: January 23, 2017
• Last updated: June 2, 2017
• Start date: December 2017
• Est. completion date: December 2020

Study information

• Verified date: June 2017
• Source: Shanghai East Hospital
• Contact: Xia LI, Dr.
• Phone: 86-21-38804518
• Email: daxia868[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: December 2020
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Ununited
• Nonunion Fracture

Intervention

Biological:
• Human Amniotic Epithelial Cells
Human Amniotic Epithelial Cells transplant after debridement

Procedure:
• debridement
debridement

Locations

Country	Name	City	State
China	Shanghai East Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai East Hospital	Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. Epub 2005 Aug 4. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	pain in fracture site		1 year
Secondary	limb functional score		1 year