NL-OMON33080已完成不适用
Effect of autologous Bone Marrow Derived Mesenchymal Stromal Cells prior to Lung Volume Reduction Surgery for Severe Pulmonary Emphysema - a phase I safety and feasibility study - - Safety of autologous mesenchymal stemcells on severe pulmonary emphysema
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •For entry in the study, the following criteria must be met:
- •a) Men and women over 50 years of age and must have stopped smoking for more than 6 months.
- •b) Subject is willing to participate in the study and has signed the informed consent.
- •c) Subject must have emphysema in both lungs demonstrated on a chest CT scan.
- •d) Subjects must have less than 15% difference in lung density between left and right lung as assessed by PulmCMS software in chest CT scan DICOM files.
- •e) Subject must have FEV1 below 40% pred (post-bronchodilator).
- •f) Subject must have a Kco gastransfer factor < 40% pred.
- •g) Subject must have flat diaphragm as demonstrated on chest film.
- •h) Patients must be able to adhere to the study visit schedule and protocol requirements.
- •i) Patient must be willing to participate in a pre-operative rehabilitation protocol.
- •j) Patients must be able to give informed consent and the consent must be obtained prior to any study procedure.
排除标准
- •a) Patients with clinical and radiological evidence of bronchiectasis.
- •b) Patients suffering from renal- or hepatic failure.
- •c) A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.
- •d) Use of any investigational drug within 1 month prior to screening
- •e) Patients with pulmonary hypertension, with mean PAP above 30 mmHg assessed by ultrasound of the chest or by transoesophageal ultrasound.
- •f) Documented HIV infection.
- •g) Active hepatitis B, hepatitis C or TB.
- •h) Subjects who currently have or who have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
- •i) Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, cardiac, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis).
- •j) Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
- •k) History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly.
- •l) Known recent substance abuse (drug or alcohol).
- •m) Poor tolerability of venapuncture or lack of adequate venous access for required blood sampling during the study period.
研究者
相似试验
已完成
1 期
Studying the effect of bone marrow mesenchymal stem cell injection into the subarachnoid space on improvement and reduction of complications in spinal cord injured patientsSpinal Cord Injury.Injury Of Spinal Cord, Level UnspecifiedIRCT2013050813267N1Shahid Sadoughi Yazd University Of Medical Sciences, Vice Chancellor for Research30
招募中
2 期
Efficacy of bone marrow-derived stem cells in treatment of knee cartilage defects.2023-503486-32-00Bioinova a.s.40
已完成
不适用
Clinical research of bone marrow-derived mesenchymal stem cell transplantation for the patients with epidermolysis bullosa.Epidermolysis bullosa (junctional, dystrophic)JPRN-UMIN000006723Osaka University Graduate School of Medicine6
进行中（未招募）
1 期
Safety of bone marrow-derived stem cells in treatment of knee cartilage defects.EUCTR2018-004067-31-CZBioinova, s.r.o.6
已完成
1 期
Safety and Feasibility Study of Administration of Mesenchymal Stemcells for Treatment of EmphysemaEmphysemaNCT01306513Leiden University Medical Center10