EUCTR2011-005441-13-IT进行中（未招募）不适用
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 - OrthoCT 1
INSERM - Institut National de la Sant? et de la Recherche m?dicale0 个研究点目标入组 30 人开始时间: 2012年12月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •· 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 nonunion
- •· 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: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •· Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control · Participation in another therapeutic trial in the previous 3 months · Delayed union or non-union related to iatrogeny · Segmental bone loss requiring specific therapy (bone transport, large structural allograft, megaprosthesis, etc) · Vascular or neural injury · Other fractures causing interference with weight bearing · Infection: skin, soft-tissue, bone or any remote infection (dental, pulmonary, gynecological) · Visceral injuries of diseases interfering with callus formation (craneoencephalic trauma, etc.) · History of bone harvesting on iliac crest contraindicating bone-marrow aspiration · Corticoid or immunosuppressive therapy more than one week in the three months prior to study inclusion · History of prior or concurrent diagnosis of HIV-, Syphilis, Hepatitis-B- or Hepatitis-C-infection (confirmed by serology or PCR) · Subject legally protected, under legal guardianship, deprived of their liberty by judicial or administrative decision, subject of psychiatric care, or admission to a health facility. · Impossibility to meet at the appointments for the follow up · Insulin dependent diabetes · Obesity (BMI > 30) · Autoimmune inflammatory disease · Current treatment by biphosphonate or stopped in the three months prior to study inclusion.
研究者
相似试验
进行中（未招募）
1 期
Development of tissue engineering therapy to treat patients with delayed consolidation after fracture of long bones.Closed or open Gustilo I ans II humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture.MedDRA version: 14.1 Level: PT Classification code 10017081 Term: Fracture delayed union System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2011-005441-13-DEINSERM30
进行中（未招募）
1 期
Development of tissue engineering therapy to treat patients with delayed consolidation after fracture of long bones.EUCTR2011-005441-13-ESINSERM30
尚未招募
1 期
Safety and clinical effectiveness of autologous mesenchymal stromal cell infusion as adjuncttreatment in patients with Idiopathic Pulmonary FibrosisJ84.1Other interstitial pulmonary diseases with fibrosisDRKS00008790The Republican Research and Practical Centre for Pulmonology and TB40
已完成
不适用
Evaluation of safety and efficacy of autologous stentless mitral valve replacement: pilot studymitral valve stenosis, mitral valve stenosis and regurgitationJPRN-UMIN000026020Kyoto Prefectural University of Medicine
招募中
Unknown
Clinical Study of Safety and Efficacy of Autologous Mesenchymal Stem Cells for Periodontal Tissue Regeneration TherapyPeriodontal DiseaseJPRN-jRCTb070230008Cho Yasushi22