AN OPEN LABEL, RANDOMISED, CONTROLLED CLINICAL TRIAL TO ASSESS THE SAFETY OF ENDOBRONCHIAL ADMINISTRATION OF ALLOGENEIC MESENCHYMAL STROMAL CELLS IN PATIENTS WITH LUNG TRANSPLANT CHRONIC REJECTION: Study ENDOSC-CLAD
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Incidence of early onset (24h) adverse events following MSCs administration: desaturation, hypotension, radiological infiltrates, fever or changes in oxygen therapy requirements.
研究概览
简要总结
To assess the safety of endobronchial administration of allogeneic MSCs in patients with BO.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients should have signed written informed consent.
- •Adult patients ≥18 years of age at the time of enrolment
- •Patients recipients of a uni or bipulmonary transplant
- •An established diagnosis of BOS ≧ 0p (FEV1≤90% and / or FEF 25-75% ≤ of the baseline value with no other justifying cause) in the last 6 months.
排除标准
- •History of lobar transplantation
- •Performance status 3 or 4 (confined to bed or chair for more than 50% of waking hours, able only to perform some self-care activities)
- •Estimated survival less than 3 months.
- •Known hypersensitivity to components used in the production of allogeneic MSCs.
- •Any circumstance that, in the opinion of the investigator, compromises the patient's ability to participate in the clinical trial.
- •History of heart-lung transplantation
- •Active infection at the time of inclusion.
- •Active Acute Rejection not treated at the time of inclusion.
- •Oncological history (except cutaneous basal cell or carcinoma in situ)
- •Systemic autoimmune diseases.
- •Active HIV / HBV / HCV infection (confirmed by serology or PCR)
- •Proximal airway stenosis
- •Pregnant women, female subjects planning or willing to get pregnant during the duration of the study will not be able to enroll.
结局指标
主要结局
Incidence of early onset (24h) adverse events following MSCs administration: desaturation, hypotension, radiological infiltrates, fever or changes in oxygen therapy requirements.
Incidence of early onset (24h) adverse events following MSCs administration: desaturation, hypotension, radiological infiltrates, fever or changes in oxygen therapy requirements.
Incidence of adverse events of special interest since randomization: lower respiratory tract infections, acute rejection (as defined by the presence of A1-A4 o B1R, B2R in biopsy), BO worsening (as measured by >10% decline in FEV1 from baseline).
Incidence of adverse events of special interest since randomization: lower respiratory tract infections, acute rejection (as defined by the presence of A1-A4 o B1R, B2R in biopsy), BO worsening (as measured by >10% decline in FEV1 from baseline).
次要结局
- Mean changes in FEV1 at 12-month from baseline.
- Proportion of patients with >10% decrease in FEV1 from baseline.
- Time to a >10% decrease in FEV1 from baseline.
- Proportion of patients progressing to grade 3 BO (as defined by a FEV1 below 50% from best value post-transplant).
- Mean changes in FVC from baseline to 12-month
- All-cause mortality rate
- Re-transplant or CLAD-related mortality rate.
- Rate of acute rejection (as defined by the presence of A1-A4 o B1R, B2R in biopsy) at any time during the 12-month follow up period.
- Incidence of presence of specific antibodies against donor HLA.
- CLAD progression, as defined by > 10% decline in FEV1 in two consecutive time-points
- Mean changes in the mMRC Scale at 12-month.
- Total hospitalization days during 12-month follow-up period.
- Proportion of patients requiring ambulatory oxygen therapy.
研究者
David Gómez de Antonio
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda