A phase Ib/IIa, randomised, double blind, parallel group, placebo controlled, multicentre study to assess the safety and efficacy of expanded Cx611 allogeneic adipose-derived stem cells (eASCs) for the intravenous treatment of adult patients with severe community-acquired bacterial pneumonia and admitted to the intensive care unit - SEPCE

TIGENIX, S.A.U.0 个研究点目标入组 180 人开始时间: 2015年11月19日最近更新: 2015年12月22日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 180

研究概览入排标准研究者记录与标识符相似试验

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. Subjects of either sex aged = 18 years and = 80 years old.
•2. Body weight between 50 kg and 100 kg.
•3. Clinical diagnosis of acute (developed within = 21 past days) community-acquired bacterial pneumonia based on the presence of two relevant signs (fever, tachypnea, leukocytosis, or hypoxemia) and radiographic findings of new pulmonary infiltrate/s.
•4. Subjects with pneumonia of sufficient severity requiring ICU management and with at least one of the two following major criteria of severity present for less than 18 hours:
•a) Requiring invasive mechanical ventilation because of the pneumonia, or
•b) Requiring treatment with vasopressors (i.e., dopamine >5 mg/kg/min or any dose of epinephrine, norepinephrine, phenylephrine or vasopressin) for at least 2 hours to maintain or attempt to maintain systolic blood pressure (SBP) >90 mm Hg (or mean arterial pressure (MAP) >70 mm Hg) after adequate fluid resuscitation.
•5. Female subjects who are surgically sterile (e.g. 2-sided tubal resection or ovariectomy) or post-menopausal (history of no menses for at least 24 months)
•Women of childbearing potential* must have negative serum or urine pregnancy test (sensitive to 25 IU human chorionic gonadotropin [hCG]). Sexually active women of childbearing potential must agree to use an adequate method of contraception during the entire duration of the study or for three months after the last dose of the investigational medicinal product, whichever occurs later. An adequate method of contraception is defined as sexual abstinence, adequate hormonal contraception (to have started at least 7 days prior to Screening visit), or an intra-uterine device (to have been in place for at least 2 months prior to Screening visit).
•*A woman of childbearing potential is sexually mature, has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 24 consecutive months(i.e. has had menses at any time in the preceding 24 consecutive months)”
•Male subjects agreeing to use condoms during the entire duration of the study or for three months after the last dose of the investigational medicinal product, whichever occurs later, or subjects having a partner who is using a highly efficient method of contraception as described above.
•6. Signed informed consent provided by the subject, the relatives or the designated legal representative according to local guidelines.
•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 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 90

排除标准

•1. Subjects with Hospital acquired-, Health Care acquired- or Ventilator associated-pneumonia.
•2. Subjects with pneumonia exclusively of viral or fungal origin*. Subjects with bacterial pneumonia co-infected with viruses and/or other microorganisms may be entered into the study.
•*Due to the short time window (up to 18 hours) between fulfilment of severity criteria (i.e. initiation of invasive mechanical ventilation or vasopressors) and administration of the first dose of study treatment, patients with a pneumonia of suspected bacterial origin can be entered into the study (confirmation of bacterial origin must be obtained afterwards)
•3. Subjects with known or suspected Pneumocystis jirovecii (formerly known as Pneumocystis carinii) pneumonia.
•4. Subjects with an aspiration pneumonia.
•5. Subjects with known active tuberculosis.
•6. Subjects with a history of post-obstructive pneumonia.
•7. Subjects with cystic fibrosis.
•8. Subjects with any chronic lung disease requiring oxygen therapy at home.
•9. Presence of other infection (i.e. meningitis) caused by same pathogen.
•10. Subjects expected to have rapidly fatal disease within 72 hours after randomization.
•11. Inability to maintain a mean arterial pressure =50 mmHg prior to Screening despite the presence of vasopressors and intravenous fluids.
•12. Subjects not expected to survive for 3 months due to other medical conditions such as end-stage neoplasm or other diseases.
•13. Subjects with primary or metastatic lung cancer or with anticipated chemotherapy within the next 90 days.
•14. Subjects with known primary immunodeficiency disorder or with acquired immune deficiency syndrome (AIDS) with CD4 count < 200 cells/mm3 or not receiving highly active antiretroviral therapy (HAART).
•15. Subjects receiving immunosuppressant therapy (including chronic treatment with any anti-tumor necrosis factor alpha (TNFa) or on chronic high doses of steroids (single administration of =2 mg/kg body weight or 20 mg/day of prednisone or equivalent for =2 weeks).
•16. Granulocytopenia, not due to sepsis, as evidenced by leukocyte absolute neutrophil count <500 per µL.
•17. Haematopoietic and lymphoreticular malignancies, unless in remission.
•18. Subjects who received any stem cell, organ or bone marrow transplant within the past 6 months.
•19. Subjects with ongoing treatment with a biological agent (e.g. antibodies, cells) or with plasma exchange treatment within the last 8 weeks.
•20. Subjects currently receiving, or having received another investigational medication within 90 days prior to start of the study (or 5 half-lives of the investigational compound, whichever is longer).
•21. Known allergies or hypersensivity to antibiotics and/or any component of CryoStor (please refer to section 9.1.2)
•22. Subjects with a known liver function deficiency, e.g. associated with liver cirrhosis (Child Pugh C) or known oesophageal varices.
•23. Subjects hospitalised in previous 15 days
•24. Conditions resulting in a New York Heart Association Class IV functional status.
•25. End-stage neuromuscular disorders that impair weaning (e.g. amyotrophic lateral sclerosis).
•26. Patients with complete quadriplegia (traumatic or otherwise).

研究者

发起方

TIGENIX, S.A.U.

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