Mesenchymal Stem Cell Therapy for Bronchopulmonary Dysplasia in Preterm Babies

Bronchopulmonary Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443961
• Other study ID #: PULMESCEL-1
• Status: Completed
• Phase: Phase 1
• Start date: April 2, 2019
• Est. completion date: July 7, 2022

Study information

• Verified date: March 2023
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 7, 2022
• Est. primary completion date: April 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 28 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Hyperplasia

Intervention

Biological:
• Mesenchymal Stem Cell (MSC) therapy
3 doses of 5 million MSC will be administered

Locations

Country	Name	City	State
Spain	Hospital Universitario A Coruña	A Coruña
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario y Politécnico La Fe	Valencia

Sponsors (3)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal	Fundación de Ayuda a la Investigación sobre la Hipertensión pulmonar, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia (Number of participants with adverse events)	Number of participants with adverse events as a measure of safety and tolerability	24 months
Secondary	Biomarker analysis (IL-1beta, IL-6, IP-10, INF-gamma, TGF beta, NLRP3, RAGE, HMGB1, VEGFA, GREMLIN1, sVEGFR1, IGF, ENDOTHELIN-1, SMPD-1, SP-D, SMPD3.	biomarkers will be measured in pg/ml	24 months
Secondary	Changes in the echocardiographic parameters related with PH and preterm birth, in patients treated with MSC (Number of participants with echocardiographic adverse events)	Flattening of the interventricular septum will be the main parameter (tipe I, I-II, II, II-III OR III)	24 months
Secondary	Incidence of BPD and PH in very low birth weight babies treated with MSC	Diagnosed at 36 weeks of postmenstrual age	24 months