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 85 人开始时间: 2015年10月29日最近更新: 2020年11月9日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 85

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. Adult subjects of either gender (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, tachypnoea, 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 for respiratory failure due to pneumonia or
•b) Requiring treatment with vasopressors (i.e., dopamine >5 µg/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 (i.e. for shock).
•NOTE: Patients that are for 18 hours or more under high flow nasal cannula (HFNC) at =50 litres per minute and FiO2 =0.6 or under non-mechanical ventilation (NMV) are not eligible for the study.
•5. Female subject of no childbearing potential i.e. non fertile, pre-menarche, permanently sterile (i.e. underwent hysterectomy, bilateral salpingectomy or bilateral ovariectomy) or post-menopausal (history of no menses for at least 12 months without an alternative medical cause)
•or Woman of childbearing potential* with a negative serum or urine pregnancy test (sensitive to 25 IU human chorionic gonadotropin [hCG]) and agree to use an adequate method of contraception for three months after the last dose of the investigational medicinal product according to her preferred and usual life style. Adequate methods of female contraception for this study are: sexual abstinence (refraining from heterosexual intercourse), hormonal contraception (both progesterone-only or combined oestrogen and progesterone; both with inhibition of ovulation or where inhibition of ovulation is not the primary mechanism of action), intra-uterine device, bilateral tubal occlusion, condom use by male sexual partner(s) or medically-assessed successfully vasectomised male sexual partner(s).
•*A woman of childbearing potential is a woman between menarche and post-menopause (history of no menses for at least 12 months without an alternative medical cause) unless she has undergone hysterectomy, bilateral salpingectomy or bilateral ovariectomy.
•Male subject agreeing to use one of the following methods of birth control according to his preferred and usual life style for three months after the last dose of the investigational medicinal product: sexual abstinence (refraining from heterosexual intercourse), use of condoms or medically-assessed successful vasectomy, or having a female sexual partner(s) who is using an adequate 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 42
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 43

排除标准

•1. Subjects with Hospital acquired (HAP)-, Health Care Associated (HCAP)- or Ventilator associated-pneumonia (VAP).
•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, whichever comes first) and the start of the first dose of study treatment, patients with a pneumonia of suspected bacterial origin by any established standard diagnostic method routinely applied at the study site (e.g. urinary antigen test, rt-PCR) 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 infection in another organ location caused by same pathogen (e.g. pneumococcal meningitis in the context of pneumococcal pneumonia).
•10. Subjects expected to have rapidly fatal disease within 72 hours after randomisation.
•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 pre-existing medical conditions such as end-stage dementia or other diseases.
•13. Subjects with a history of malignancy in the 5 years prior to screening, except for successfully surgically treated non-melanoma skin malignancies.
•14. Subjects with known primary immunodeficiency disorder or with HIV infection and acquired immune deficiency syndrome (AIDS) with CD4 count <200 cells/mm3 or not receiving highly active antiretroviral therapy (HAART) for HIV.
•15. Subjects receiving immunosuppressant therapy (including chronic treatment with any anti-tumour necrosis factor alpha (TNFa) or on chronic high doses of steroids (single administration of =2 mg/kg body weight for =2 weeks or 20 mg/day of prednisone or equivalent for =2 weeks).
•16. Chronic granulocytopenia, not thought to be due to sepsis, as evidenced by an absolute neutrophil count <500 per µL >21 days prior to onset of pneumonia symptoms.
•17. Subjects who received stem cell therapy, or allogenic transplantation (organ or bone marrow transplant) within the past 6 months.
•18. Subjects receiving treatment with a biological agent (e.g. antibodies, cells), immunotherapy or plasma exchange treatment within the last 8 weeks.
•19. 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).
•20. Known allergies or hypersensivity to Penicillin or Streptomycin and/or any component of CryoStor (please refer to section 9.1.2).
•21. Subjects with a known liver function impairment associated with liver cirrhosis (Child Pugh C) or known oesophageal varices.
•22. Subjects hospitalised within the previous 15 days
•23. Conditions resulting in a New York Heart Association or Canadian Cardiovascular Society Class IV functional status.
•24. End-stage neuromuscular disorders (e.g. motor neuron dise

研究者

发起方

TIGENIX, S.A.U.

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