EUCTR2013-005025-23-ES进行中（未招募）1 期
A phase IIa, unicenter, prospective, randomized, parallel, two-arms, single-dose, open-label with blinded assessor pilot clinical trial to assess ex vivo expanded adult autologous mesenchymal stromal cells fixed in allogeneic bone tissue (XCEL-MT-OSTEO-ALPHA) in non hypertrphic pseudoarthrosis of long bones
Banc de Sang i Teixits (BST)0 个研究点目标入组 20 人开始时间: 2014年1月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
入选标准
- •1. 18 to 85 years of age (male and female)
- •2. Atrophic or hypothrophic metaphyseal?diaphyseal pseudarthrosis of long bones, confirmed radiographically.
- •3. Informed Consent Form signed
- •4. The patient is able to understand the nature of the study
- •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 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Suspicious of pseudarthrosis focus infection diagnosed by clinical inspection and blood analysis.
- •2. Positive serology for HIV (Anti-HIV I/II-Ac), Hepatitis B (HBsAg, HBcAc), Hepatitis C (Anti-HCV-Ac) or Syphilis Lúes (TP-Ac).
- •3. Significant abnormal laboratory tests that contraindicates patient?s participation in the study.
- •4. Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
- •5. Smoker of more than 15 cigarettes a day
- •6. Congenital disorders of bones (hypophosphatemia), bone metabolic disorders associated to primary or secondary hypoparathyroidism.
- •7. Badly managed diabetes mellitus.
- •8. Patients diagnosed with peripheral arterial disorders
- •9. Previous therapeutic radiation (5 previus years) of the affected bone.
- •10. Neoplasia within the previous 5 years, or without remission
- •11. The patient is legally dependent
- •12. Participation in another clinical trial or treated with an investigational medicinal product the previous 30 days
- •13. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
- •14. The patient does not accept to be followed-up for a period that could exceed the clinical trial length
研究者
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