EUCTR2012-000292-16-ES进行中（未招募）不适用
Phase IIa clinical trial to test the feasibility and safety of using autologous mesenchymal stem cells from fat in the local treatment of bronchopleural fistula - HULPTOR
Fundación para la Investigación Biomédica del Hospital Universitario La Paz (FIBHULP)0 个研究点开始时间: 2013年4月9日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1. Being over 18 years
- •2 Having accessible bronchopleural fistula pathology endoscopic approach.
- •3. Prior control of the fistula with the usual techniques ((pleural drainage, infection control, open thoracostomy and / or endotracheal prosthesis-bronchial)
- •4. Fistula refracted to conventional medical or surgical treatment.
- •5. Have signed the informed consent
- •6. Negative pregnancy test and acceptance of the use of highly effective contraceptive methods if applicable.
- •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 8
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Mental retardation incapacitating signing the informed consent.
- •2. Urgency in treatment.
- •3. Pleural cavity with uncontrolled infection.
- •4. Extreme malnutrition (BMI <18.5 kg/m2) who advise against liposuction.
- •5. Presence of uncontrolled malignancy or progression phase.
- •6. Inability to tolerate the anesthetic and / or bronchoscopic implant required for ASC.
- •7. Administration of any investigational drug at present to three months prior to enrollment for this trial.
- •8. Infants and pregnant women.
- •9. Adult women of childbearing age not using effective contraception as ICH guidance M3 EMA during the test.
研究者
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