drugset / Trial / NCT03031509
Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells（hAECs）
Phase 1/2
Unknown
36 enrolled
Shanghai East Hospital
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2017-12
- Primary completion
- 2018-03
- Completion
- 2020-12
Publications
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | human amniotic epithelial cells | Cell therapy | 50 cells | — |
Indications
No indication recorded.