Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia.

Официальное название

Clinical Trial to Stablish the Security of Using Allogeneic Fetal Stem Mesenchymal Cells From Umbilical Cord, Expanded in Pre-term Patients Suffering of Bronchopulmonary Dysplasia.

Обзор

Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly. Allogeneic fetal stem mesenchymal cells from umbilical cord could reduce the prevalence of BPD in this patients.

Подробное описание

Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly, and it is a disease that is nowadays increasing due to the improvement in the survival of this patients (affecting 15-50% of them).

In the Fase I Clinical Trial, the use of allogeneic fetal stem mesenchymal cells from umbilical cord proved to be safe, with no mortality or Adverse Events reported. The Fase II Clinical Trial is based in the hypothesis that the administation of mesenchymal stem cells is not only safe but feasible and can help reducing the chance of a preterm newborn patient developing BPD.

Вмешательства

• Биопрепарат Control
  Standard treatment
• Биопрепарат Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions
  3 doses of 5 million MSC will be administered
• Биопрепарат Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions
  6 doses of 5 million MSC will be administered

Первичные конечные точки

• Security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia [Срок оценки: 24 months]
• feasibility variable [Срок оценки: 24 months]

Вторичные конечные точки (12)

• Incidence of BPD and PH in very low birth weight babies treated with MSC [Срок оценки: 24 months]
• Diagnosis and stage of bronchopulmonary dysplasia on week 36 of post-menstrual age according to Jensen [Срок оценки: 24 months]
• Exitus on week 36 and 40 of post-menstrual age or at hospital discharge [Срок оценки: 24 months]
• Incidence of comorbidities resulting from prematurity from the time of screening to 40 weeks' EPM, hospital discharge or death. [Срок оценки: 24 months]
• Biomarker analysis (IL-1beta, IL-6, IL8, TGF beta, TNF alfa, GM-CSF, NLRP3, RAGE, HMGB1, VEGF, HGF, GREMLIN1, sVEGFR1, SP-D, SMPD1, SMPD3, IsoPs, IsoFs, NeuroPs, NeuroFs, miRNAs). [Срок оценки: 24 months]
• Variations in echocardiographic parameters of pulmonary hypertension (PH) before and after mesenchymal cell therapy. [Срок оценки: 24 months]
• Changes in modified respirator score during therapy and up to week 36 of port-menstrual age [Срок оценки: 24 months]
• Changes in Respiratory Severity Score (RSS) during therapy and up to week 36 of port-menstrual age [Срок оценки: 24 months]
• Date of hospital discharge and respiratory care at discharge. [Срок оценки: 24 months]
• Need for supplemental O2 at home discharge and during follow-up (Number if patients that need supplemental O2). [Срок оценки: 24 months]
• Duration of invasive and non-invasive mechanical ventilation. [Срок оценки: 24 months]
• Use of postnatal corticosteroids indicated [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Alive newborns weighing ≤ 1250 grams and GA ≤ 28 weeks, who are on mechanical ventilation with a FiO2 ≥0.3 between days 5 and 14 of life, with no immediate extubation foreseeable.

Критерии исключения

• Presence of another concomitant congenital pathology at the time of inclusion: pulmonary malformations with compromised pulmonary function, active pulmonary haemorrhage, severe pulmonary hypoplasia, renal malformations with systemic compromise, congenital heart disease, polymalformative syndromes, chromosomopathies.
• Presence of refractory haemodynamic instability of any cause at the time of inclusion.
• Presence of severe neurological damage at the time of inclusion (HIV grade III or higher).
• Patients who have required major surgery in the 72 hours prior to inclusion.
• Patients who have necrotising enterocolitis (NEC) grades ≥II at the time of inclusion, according to the Bell classification.
• Patients who are children of a mother with HIV

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 7 центров

• Hospital Quironsalud Madrid — Pozuelo de Alarcón
• Complejo Hospitalario La Coruña — A Coruña
• Hospital Clínico San Carlos — Madrid
• Hospital Universitario La Paz — Madrid
• Hospital Universitario Carlos Haya — Málaga
• Hospital Vírgen del Rocío — Seville
• Hospital Universitario y Politécnico La Fe — Valencia

Идентификаторы

NCT: NCT06270199 · PULMESCELL-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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