EUCTR2020-001577-70-IT进行中（未招募）1 期
Allogeneic Mesenchymal Stromal Cell (MSC) Therapy for SARS-CoV-2 Pneumonia: A Prospective Randomized Multicentre Phase I/IIa Open Label Study - RESCAT
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •Adult patients suffering from SARS-CoV-2 induced severe pneumonia admitted to semi-intensive or intensive COVID Units because of the need of ventilation support.
- •Sign of the informed consent,
- •Patients of either sex, aged 18-80 years (inclusive),
- •Patient with a confirmed virological diagnosis of SARS-CoV2 infection by means of real-time Polymerase Chain Reaction,
- •Hospitalization due to clinical and radiological diagnosis of pneumonia,
- •PaO2/FiO2 value between 150-300 with impending necessity of noninvasive positive pressure respiratory support (nCPAP) or ventilator support through nasal pressure support ventilation (nPSV),
- •Systolic artery pressure >90 mmHg without amine support,
- •Modified Early Warning Score (MEWS) score <3,
- •Absence of known active malignancy.
- •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) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Deny to informed consent,
- •Known history of alcohol or drug abuse in the 12 months prior to inclusion,
- •Presence of significant comorbidities, such as uncontrolled hypertension, invalidating psychiatric or neurological disorders, organ failure (renal impairment defined by creatinine clearance below 50 ml/min or by serum creatinine =2.0 mg/dl; hepatic impairment defined by total bilirubin =2.0 mg/dl and AST + ALT = 2.5 x upper normal value; cardiac failure with an output fraction =40%), or any other clinically significant condition, as determined by the Principal Investigator,
- •Presence of chronic advanced cardio-pulmonary diseases, such as ILDs (obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis),
- •Patient has a clinically relevant abnormality on electrocardiogram, as determined by the Principal Investigator,
- •History of previous embolism,
- •Known active malignancy,
- •Patient with a history of severe allergic reactions (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) requiring medical intervention,
- •Patient with a positive test for human immunodeficiency virus or active hepatitis B or C disease or tuberculosis or further viral infections (influenza virus, adenovirus and other respiratory viruses),
- •Patient is known to be pregnant, has a positive pregnancy test or is nursing,
- •Patient has had major surgery, either open or laparoscopic, within the 3 months prior to screening,
- •Previous haematopoietic stem cell or organ transplantation,
- •Patient under immunosuppressive agents,
- •Patients currently receiving, or having received within 2 months prior to enrolment into this clinical study, any other investigational drug.
研究者
相似试验
进行中（未招募）
不适用
Mesenchymal Stromal Cells (MSC) for the treatment of severe (grade II-IV) steroid-resistant Graft Versus Host Disease (GVHD): a phase I trial - MSC-GvHDGraft versus Host disease GvHD steroid resistantEUCTR2008-007869-23-ITAZIENDA OSPEDALIERA SAN GERARDO DI MONZA
撤回
2 期
Mesenchymal stromal cell (MSC) transplantation in septic shock.septisch shockseptic shock and severe blood poisoning1002766510002252NL-OMON39173Erasmus MC, Universitair Medisch Centrum Rotterdam30
招募中
1 期
Cell therapy with use of mesenchymal stem cells in infertile women with Thin EndometriumIRCT20230222057500N1Tehran University of Medical Sciences10
进行中（未招募）
不适用
Mesenchymal stem cell based therapy for the treatment of osteogenesis imperfectaOsteogenesis imperfecta (OI) is a rare genetic disorder with increased bone fragility of varying severity. In the majority of patients the disease is caused by mutations in collagen type I. Severe OI is characterized by osteopenia, frequent fractures, progressive deformity, short stature, loss of mobility, chronic pain and can lead to premature death. At present a cure does not exist.EUCTR2012-002553-38-ESItziar Astigarraga Aguirre
进行中（未招募）
1 期
Infusion of mesenchymal stem cells as treatment for steroid resistant grade II to IV acute GVHD or poor graft function: a multicenter phase II studyEUCTR2007-004310-14-BECHU-ULG120