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Trial record 1 of 19 for:    MSC | Bronchopulmonary Dysplasia
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Mesenchymal Stem Cell Therapy for Bronchopulmonary Dysplasia in Preterm Babies

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ClinicalTrials.gov Identifier: NCT02443961
Recruitment Status : Recruiting
First Posted : May 14, 2015
Last Update Posted : February 6, 2020
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Fundación de Ayuda a la Investigación sobre la Hipertensión pulmonar
Information provided by (Responsible Party):
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Brief 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.

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Biological: Mesenchymal Stem Cell (MSC) therapy Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical Trial: Security and Feasibility of Mesenchymal Stem Cell Therapy in Treatment and Prevention of Bronchopulmonary Dysplasia in Preterm Babies
Actual Study Start Date : April 2, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mesenchymal Stem Cell (MSC) therapy
There will only be one treatment arm to evaluate the security of the treatment with MSC.
Biological: Mesenchymal Stem Cell (MSC) therapy
3 doses of 5 million MSC will be administered




Primary Outcome Measures :
  1. 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) [ Time Frame: 24 months ]
    Number of participants with adverse events as a measure of safety and tolerability


Secondary Outcome Measures :
  1. 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. [ Time Frame: 24 months ]
    biomarkers will be measured in pg/ml

  2. Changes in the echocardiographic parameters related with PH and preterm birth, in patients treated with MSC (Number of participants with echocardiographic adverse events) [ Time Frame: 24 months ]
    Flattening of the interventricular septum will be the main parameter (tipe I, I-II, II, II-III OR III)

  3. Incidence of BPD and PH in very low birth weight babies treated with MSC [ Time Frame: 24 months ]
    Diagnosed at 36 weeks of postmenstrual age



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Ages Eligible for Study:   1 Month to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443961


Contacts
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Contact: Maria Jesús del Cerro, PhD 34 91 36 8000 majecerro@yahoo.es
Contact: María Alvarez, MD 34 9 336 8000 mery1812@hotmail.com

Locations
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Spain
Hospital Universitario A Coruña Recruiting
A Coruña, Spain
Contact: Alejandro Ávila         
Hospital Clínico San Carlos Recruiting
Madrid, Spain
Contact: Luis Arruza         
Hospital Universitario La Paz Recruiting
Madrid, Spain
Contact: Paloma Lopez         
Hospital Universitario y Politécnico La Fe Recruiting
Valencia, Spain
Contact: Máximo Vento         
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Instituto de Salud Carlos III
Fundación de Ayuda a la Investigación sobre la Hipertensión pulmonar
Investigators
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Principal Investigator: Maria Jesus del Cerro, PhD IRYCIS. Hospital Universitario Ramón y Cajal. Madrid. Spain

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Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT02443961    
Other Study ID Numbers: PULMESCEL-1
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal:
Bronchopulmonary dysplasia
pulmonary hypertension
stem cell therapy
mesenchymal stem cells
very low weight preterm babies
Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Hyperplasia
Pathologic Processes
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases