Evaluation of efficacy and safety of autologous MSCs combined to biomaterials to enhance bone healing in patients with delayed consolidation after long bone fracture requiring graft apposition or alternative orthobiologics. - REBORNE - ORthoCT1

INSERM0 个研究点目标入组 30 人开始时间: 2012年5月18日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•- age 18 to 65 both sexes
•- traumatic isolated closed or open Gustilo I and II humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture status delayed union or non union
•- at least 3 months from acute fracture
•- able to provide informed consent, and signed informed consent
•- patients (by themselves) should have medical health care coverage to be included in a research study
•- able to understand and accept the study constraints
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control
•- participation in another therapeutic trial previous 3 months
•- delayed union or non-union related to iatrogeny
•- segmental bone loss requiring therapy
•- vascular or neural injury
•- impossibility to meet appointments for the follow up
•- other fractures causing interference with weight bearing
•- infection
•viceral injuries of diseases interfering with callus formation
•- history of bone harvesting on iliac crest contraindicating bone-marriw aspiration
•- corticoid or immunosuppressive therapy more than one week in the 3 mionths prior ti study inclusion
•- history of prior concurrent diagnosis of HIV, Hepatitis B or C infection
•- insulin dependent diabetes
•- autoimmune inflammatory disease
•- current treatment by bisphonate or stopped in the 3 months prior to stydy inclusion
•- subject legally protected, under legal guardianship, deprived of their liberty by judicial or administrative decision, subject of psychiatric care, or admission a health facility.

发起方