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Mesenchymal Stem Cell Therapy for Bronchopulmonary Dysplasia in Preterm Babies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02443961
Recruitment Status : Active, not recruiting
First Posted : May 14, 2015
Last Update Posted : February 3, 2021
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

Tracking Information
First Submitted Date  ICMJE May 4, 2015
First Posted Date  ICMJE May 14, 2015
Last Update Posted Date February 3, 2021
Actual Study Start Date  ICMJE April 2, 2019
Actual Primary Completion Date April 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
  • 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
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mesenchymal Stem Cell Therapy for Bronchopulmonary Dysplasia in Preterm Babies
Official Title  ICMJE Clinical Trial: Security and Feasibility of Mesenchymal Stem Cell Therapy in Treatment and Prevention of Bronchopulmonary Dysplasia in Preterm Babies
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Bronchopulmonary Dysplasia
Intervention  ICMJE Biological: Mesenchymal Stem Cell (MSC) therapy
3 doses of 5 million MSC will be administered
Study Arms  ICMJE Experimental: Mesenchymal Stem Cell (MSC) therapy
There will only be one treatment arm to evaluate the security of the treatment with MSC.
Intervention: Biological: Mesenchymal Stem Cell (MSC) therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 11, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2025
Actual Primary Completion Date April 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 28 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02443961
Other Study ID Numbers  ICMJE PULMESCEL-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study Sponsor  ICMJE Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborators  ICMJE
  • Instituto de Salud Carlos III
  • Fundación de Ayuda a la Investigación sobre la Hipertensión pulmonar
Investigators  ICMJE
Principal Investigator: Maria Jesus del Cerro, PhD IRYCIS. Hospital Universitario Ramón y Cajal. Madrid. Spain
PRS Account Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP