Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells（hAECs）
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|ClinicalTrials.gov Identifier: NCT03031509|
Recruitment Status : Unknown
Verified June 2017 by Shanghai East Hospital.
Recruitment status was: Not yet recruiting
First Posted : January 25, 2017
Last Update Posted : June 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Nonunion Fracture||Biological: Human Amniotic Epithelial Cells Procedure: debridement||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells（hAECs）|
|Estimated Study Start Date :||December 2017|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||December 2020|
Experimental: hAECs treatment
Human Amniotic Epithelial Cells of 50 million transplant to nonunion site after debridement surgery
Biological: Human Amniotic Epithelial Cells
Human Amniotic Epithelial Cells transplant after debridement
Sham Comparator: debridement surgery
- time for bone union [ Time Frame: 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.
- pain in fracture site [ Time Frame: 1 year ]
- limb functional score [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031509
|Contact: Xia LI, Dr.||86-21-38804518 ext email@example.com|
|Shanghai East Hospital|
|Shanghai, China, 021|
|Contact: LIN LI 86-021-61569006 ext 9829|
|Principal Investigator:||XIA LI, Dr.||Shanghai East Hospital|