Clinical trial NCT03031509: Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells（hAECs）
Official title: Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells（hAECs）
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Nonunion Fracture
Keywords: Nonunion Fracture of limb
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
First posted: 2017-01-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: time for bone union
timeFrame: 6 months
Secondary outcomes:
measure: pain in fracture site
timeFrame: 1 year
measure: limb functional score
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital
Study officials:
affiliation: Shanghai East Hospital
name: XIA LI, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1634/stemcells.2004-0357. Epub 2005 Aug 4.
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.
citation: 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.