Bronchopulmonary DysplasiaPhase 2NCT06270199
Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia.
A Phase 2 study testing Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions and Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions in people with Bronchopulmonary Dysplasia, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 7 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 28 weeks
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions and Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 7 sitesSpain
- Study dates
- 11 Jan 2024to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 28 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Spain7 sites, 7 recruiting
- Recruiting
Complejo Hospitalario La Coruña
A Coruña
Alejandro Dávila
- Recruiting
Hospital Clínico San Carlos
Madrid
Luis Arruza
- Recruiting
Hospital Universitario La Paz
Madrid
Paloma Lopez
- Recruiting
Hospital Universitario Carlos Haya
Málaga
Tomás Sánchez Tamayo
- Recruiting
Hospital Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223
Fernando Cabañas
- Recruiting
Hospital Vírgen del Rocío
Seville
Antonio Pavón Delgado
María José Moreno Valera
- Recruiting
Hospital Universitario y Politécnico La Fe
Valencia
Máximo Vento
About this study
Official title: 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.
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.
Read the detailed description
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.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Control, Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions, Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions
- Keywords
- Bronchopulmonary dysplasia, Preterm newbnorn, Mesenchymal stem cells
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBiological
Standard treatment
Allogenic fetal mesenchymal stem cells from umbilical cord - three infusionsBiological
3 doses of 5 million MSC will be administered
Allogenic fetal mesenchymal stem cells from umbilical cord - six infusionsBiological
6 doses of 5 million MSC will be administered
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard cell therapy (control group) Receives: Biological: Control |
| Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions | Experimental | Treatment: three infusions of MSC 5x10^6/Kg Receives: Biological: Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions |
| Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions | Experimental | Treatment: six infusions of MSC 5x10^6/Kg Receives: Biological: Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia
Number of patients with adverse events during the infusion time and during all study; and comorbilities due to preterm birth.
Measured: 24 months
feasibility variable
Number of days of life from birth to administration of the first dose and number of days of life in successive doses.
Measured: 24 months
Secondary outcomes (15)
Incidence of BPD and PH in very low birth weight babies treated with MSC
Status on week 36 of post-menstrual age
Measured: 24 months
Diagnosis and stage of bronchopulmonary dysplasia on week 36 of post-menstrual age according to Jensen
(No BPD/grade 1/grade 2/garde 3)
Measured: 24 months
Exitus on week 36 and 40 of post-menstrual age or at hospital discharge
(Yes/No)
Measured: 24 months
Incidence of comorbidities resulting from prematurity from the time of screening to 40 weeks' EPM, hospital discharge or death.
(sepsis confirmed by blood culture, treated patent ductus arteriosus, non-pharmacological ductal closure, necrotising enterocolitis, isolated bowel perforation, intraventricular haemorrhage ≥ 2, retinopathy ≥ grade 2)
Measured: 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).
biomarkers will be measured in pg/ml
Measured: 24 months
Variations in echocardiographic parameters of pulmonary hypertension (PH) before and after mesenchymal cell therapy.
NO PH (type I less 35%), MILD PH (type I-II between 35-50%) , MODERATE PH (type II between 50-70%) and SEVERE PH ( type II-III, more than 70%)
Measured: 24 months
Changes in modified respirator score during therapy and up to week 36 of port-menstrual age
0 - 13 (min- max value). Higher score means worse outcome.
Measured: 24 months
Changes in Respiratory Severity Score (RSS) during therapy and up to week 36 of port-menstrual age
0-30 (min- max value). Higher score means worse outcome.
Measured: 24 months
Date of hospital discharge and respiratory care at discharge.
Date of hospital discharge and respiratory care at discharge.
Measured: 24 months
Need for supplemental O2 at home discharge and during follow-up (Number if patients that need supplemental O2).
Number if patients that need supplemental O2
Measured: 24 months
Duration of invasive and non-invasive mechanical ventilation.
Duration of invasive and non-invasive mechanical ventilation.
Measured: 24 months
Use of postnatal corticosteroids indicated
For the treatment or prevention of BPD
Measured: 24 months
Respiratory readmission rates.
During the first year
Measured: 24 months
Bayley Neurodevelopmental Scale at 24 months
Evaluation of cognitive developement, languaje developement and motor developement.
Measured: 24 months
Date and cause of death.
Date and cause of death.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start11 Jan 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Group Assignment
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- María Jesús del Cerro, PhD, Principal investigator, IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270199
- Sponsor's protocol ID
- PULMESCELL-2
- Status last verified
- Oct 2026
- First submitted
- 16 Jan 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06270199
- Acronym / sponsor ID
- PULMESCELL-2
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Bronchopulmonary dysplasia, Preterm newbnorn, Mesenchymal stem cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Biological: ControlStandard cell therapy (control group) |
| Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions | Experimental | Biological: Allogenic fetal mesenchymal stem cells from umbilical cord - three infusionsTreatment: three infusions of MSC 5x10^6/Kg |
| Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions | Experimental | Biological: Allogenic fetal mesenchymal stem cells from umbilical cord - six infusionsTreatment: six infusions of MSC 5x10^6/Kg |
Who may qualify
- Ages
- 1 month to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlStandard treatment | Biological | Control |
| Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions3 doses of 5 million MSC will be administered | Biological | Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions |
| Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions6 doses of 5 million MSC will be administered | Biological | Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions |
Primary outcome
Security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia
Time frame: 24 months
Number of patients with adverse events during the infusion time and during all study; and comorbilities due to preterm birth.
feasibility variable
Time frame: 24 months
Number of days of life from birth to administration of the first dose and number of days of life in successive doses.
15 secondary outcomes
Incidence of BPD and PH in very low birth weight babies treated with MSC
Time frame: 24 months
Diagnosis and stage of bronchopulmonary dysplasia on week 36 of post-menstrual age according to Jensen
Time frame: 24 months
Exitus on week 36 and 40 of post-menstrual age or at hospital discharge
Time frame: 24 months
Incidence of comorbidities resulting from prematurity from the time of screening to 40 weeks' EPM, hospital discharge or death.
Time frame: 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).
Time frame: 24 months
Variations in echocardiographic parameters of pulmonary hypertension (PH) before and after mesenchymal cell therapy.
Time frame: 24 months
Changes in modified respirator score during therapy and up to week 36 of port-menstrual age
Time frame: 24 months
Changes in Respiratory Severity Score (RSS) during therapy and up to week 36 of port-menstrual age
Time frame: 24 months
Date of hospital discharge and respiratory care at discharge.
Time frame: 24 months
Need for supplemental O2 at home discharge and during follow-up (Number if patients that need supplemental O2).
Time frame: 24 months
Duration of invasive and non-invasive mechanical ventilation.
Time frame: 24 months
Use of postnatal corticosteroids indicated
Time frame: 24 months
Respiratory readmission rates.
Time frame: 24 months
Bayley Neurodevelopmental Scale at 24 months
Time frame: 24 months
Date and cause of death.
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
Related trials for Bronchopulmonary Dysplasia
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
María Jesús del Cerro, PhD principal investigator
IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions and Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions in people with Bronchopulmonary Dysplasia, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María Jesús del Cerro, PhD (34 91 36 8000, majecerro@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.