EUCTR2015-000431-32-DE进行中（未招募）1 期
A MULTI-CENTRE, OPEN-LABEL, RANDOMIZED, COMPARATIVE CLINICAL TRIAL OF TWO DIFFERENT DOSES OF BONE MARROW AUTOLOGOUS HUMAN MESENCHYMAL STEM CELLS PLUS BIOMATERIAL VERSUS ILIAC CREST AUTOLOGOUS GRAFT, FOR BONE HEALING IN NON-UNION AFTER LONG BONE FRACTURES. - ORTHOUNIO
niversidad Autónoma de Madrid (U.A.M.)0 个研究点目标入组 108 人开始时间: 2017年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 108
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
- •To be eligible to enter the study candidates must satisfy all of the following criteria:
- •1. Age 18 and older, both sexes
- •2. Traumatic isolated closed or open Gustilo I and II, IIIA and IIIB humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture with a status of atrophic, oligotrophic or normotrophic non-union. A non-union is defined as a fracture not healed at least 9 months after the originating trauma, that meets the following criteria (Weber 1986):
- •- Insufficient bone bridging to stabilize the fracture
- •- Insufficient bone biological activity in the fracture
- •- Failure of previous treatments
- •3. Able to understand, accept and sign informed consent
- •4. Medical health coverage
- •5. 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 78
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Hypertrophic non-unions
- •2. Segmental bone loss requiring specific therapy (bone transport, vascularized graft, large structural allograft, megaprosthesis, etc)
- •3. Unrecovered vascular or neural injury
- •4. Other fractures causing interference with weight bearing
- •5. Visceral injuries or diseases interfering with callus formation (severe cranioencephalic trauma, etc.)
- •6. Active infection of any location and aetiology
- •7. Surgical contraindication of any cause
- •8. Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control. The following methods are considered adequate:
- •- Combined hormonal contraception
- •- Injected hormonal contraception
- •- Implanted hormonal contraception
- •- Progesterone-only hormonal contraception associated with inhibition of ovulation
- •- Placement of an intrauterine device (IUD)
- •- Placement of intrauterine hormone-realising system (IUS)
- •- Sexual abstinence
- •9. Malignant tumor (past history or concurrent disease) (except carcinoma in situ or basalioma in remission)
- •10. History of bone harvesting on iliac crest contraindicating new iliac crest bone graft harvesting or bone marrow collection
- •11. Insulin dependent diabetes
- •12. Any evidence (confirmed by PCR) of active infection with HIV, Hepatitis B or Hepatitis C infection
- •13. Any evidence of Syphilis
- •14. Known allergies to products involved in the production process of MSC
- •15. Corticoid or immunosuppressive therapy more than one week in the three months prior to study inclusion
- •16. Autoimmune inflammatory disease
- •17. Current treatment by biphosphonates not stopped three months prior to study inclusion
- •18. Impossibility to meet at the appointments for the follow up
- •19. Participation in another therapeutic trial in the previous 3 months
- •20. Second non-union in case of bilateral or multiple non-unions (only one non-union per patient will be included in the trial)
研究者
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