evaluation of efficacy and side effects of implantation of bone marrow-derived mesenchymal stromal cells in combination with platelet lysate product in reconstruction of human nonunion of tibia fractures/a phase2 & 3 clinical trial

Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell0 个研究点目标入组 60 人开始时间: 待定最近更新: 2018年2月22日

适应症

试验速览

暂无简介。

•1-patients with 18-65 years old; 2- both male & female patients; 3- patients with nonunion of tibial midshaft; 4- Fracture must be located in the middle third of the tibia; 5- Nonunion gap must be less than 1 cm. in the radiology; 6- Fracture fixed by closed intra medullary rod; 7- Patient informed the consent; 8- Atrophic type nonunion; 9- 6 months last from the first operation; 10- Second procedure for nonunion has not done.
•Exclusion criteria:1- infected nonunion; 2- Multiple major fractures; 3- Major untreated fracture; 4- History of cancer; 5- Allergy to protein or other cell culture medium gradients; 6- Uncontrolled chronic diseases; 7- Need to steroid usage in the period of treatment; 8- Positive for HIV or other viral diseases; 9- Pregnant or lactating women; 10- Include in other trail

发起方

Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell