Trial | NCT02443961  Report issue

Title

Mesenchymal Stem Cell Therapy for Bronchopulmonary Dysplasia in Preterm Babies
Clinical Trial: Security and Feasibility of Mesenchymal Stem Cell Therapy in Treatment and Prevention of Bronchopulmonary Dysplasia in Preterm Babies

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    10
Bronchopulmonary Dysplasia (BPD) is the most frequent disease related to a premature birth, 15-50% of very low birth newborns (<1500 gr.) will develop BPD. The prevalence of BPD is increasing due to the advances in neonatology, with a rise in the survival of smaller and more premature babies. The etiology of BPD is multifactorial, in which oxygen, maternal chorioamnionitis, insufficient pulmonary maturation etc. have an important role. These factors lead to a pathological development of the lung and pulmonary vessels, developing secondary Pulmonary Hypertension (PH). Nowadays there is no efficient treatment; this generates a important sanitary burden and a decrease in life quality. Multiple experimental models in mice have studied Mesenchymal Stem Cell (MSC) therapy as prevention of BPD, also recently some clinical trials have tried this therapy on premature newborns with promising results. Hypothesis: MSC therapy in patients at high risk of BPD prevents pulmonary lesions. Methods: The investigators have designed a clinical trial to evaluate the feasibility and security of MSC therapy in patients at high risk of developing BPD.
Study Started
Apr 02
2019
Primary Completion
Apr 02
2020
Study Completion
Jul 07
2022
Last Update
Mar 30
2023

Biological Mesenchymal Stem Cell (MSC) therapy

3 doses of 5 million MSC will be administered

Mesenchymal Stem Cell (MSC) therapy Experimental

There will only be one treatment arm to evaluate the security of the treatment with MSC.

Criteria 

Inclusion Criteria:

Preterm newborns ≤ 28 weeks gestational age
Birth Weight <1250 gr.
Still on of mechanical ventilation FiO2 > 0,3 at day + 14

Exclusion Criteria:

Other congenital pathology (pulmonary malformations, active pulmonary bleeding, renal malformations, CHD, malformative syndromes, chromosomopathies)
Severe neurological lesion.
HIV infection
Cardiovascular instability due to any cause
72 hours after mayor surgery
Necrotizing enterocolitis grades II or higher, according to Bell classification, at the time of inclusion.
No Results Posted