Bronchopulmonary DysplasiaPhase 1NCT02443961

Mesenchymal Stem Cell Therapy for Bronchopulmonary Dysplasia in Preterm Babies

A Phase 1 study testing Mesenchymal Stem Cell (MSC) therapy in people with Bronchopulmonary Dysplasia, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 4 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 1 week to 28 weeks
Conditions the study is for: Bronchopulmonary Dysplasia
What is being tested?: Mesenchymal Stem Cell (MSC) therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 4 sitesSpain
Study dates: 2 Apr 2019to 7 Jul 2022
Phase: Phase 1
Are there results?: None posted in the registry

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 week to 28 weeks
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

4 sites in 1 country.

Spain4 sites

Hospital Universitario A Coruña
A Coruña
Hospital Clínico San Carlos
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario y Politécnico La Fe
Valencia

Other trials in Spain

About this study

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

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.

Conditions: Bronchopulmonary Dysplasia
Being tested: Mesenchymal Stem Cell (MSC) therapy
Keywords: Bronchopulmonary dysplasia, pulmonary hypertension, stem cell therapy, mesenchymal stem cells, very low weight preterm babies
Medical subject headings: Bronchopulmonary Dysplasia, Hypertension, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mesenchymal Stem Cell (MSC) therapyBiological
3 doses of 5 million MSC will be administered

Study groups in NCT02443961
Study group	Role	What they receive
Mesenchymal Stem Cell (MSC) therapy	Experimental	There will only be one treatment arm to evaluate the security of the treatment with MSC. Receives: Biological: Mesenchymal Stem Cell (MSC) therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 24 months

Secondary outcomes (3)

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
Measured: 24 months
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)
Measured: 24 months
Incidence of BPD and PH in very low birth weight babies treated with MSC
Diagnosed at 36 weeks of postmenstrual age
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 20197 Jul 2022

First posted14 May 2015 (estimated)
Study start2 Apr 2019
Primary completion2 Apr 2020
Study completion7 Jul 2022

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 1
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02443961
Sponsor's protocol ID: PULMESCEL-1
Status last verified: Mar 2025
First submitted: 4 May 2015
Last updated: 17 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
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 recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
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

All Bronchopulmonary Dysplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Trial: Security and Feasibility of Mesenchymal Stem Cell Therapy in Treatment and Prevention of Bronchopulmonary Dysplasia in Preterm Babies
ClinicalTrials.gov ID: NCT02443961
Acronym / sponsor ID: PULMESCEL-1
Conditions: Bronchopulmonary Dysplasia
Keywords: Bronchopulmonary dysplasia, pulmonary hypertension, stem cell therapy, mesenchymal stem cells, very low weight preterm babies
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
Collaborators: Instituto de Salud Carlos III, Fundación de Ayuda a la Investigación sobre la Hipertensión pulmonar
Study start: 2 Apr 2019 (actual)
Primary completion: 2 Apr 2020 (actual)
Study completion: 7 Jul 2022 (actual)
First posted: 14 May 2015 (estimated)
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.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Mesenchymal Stem Cell (MSC) therapy	Experimental	Biological: Mesenchymal Stem Cell (MSC) therapyThere will only be one treatment arm to evaluate the security of the treatment with MSC.

Who may qualify

Ages: 1 week to 28 weeks
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

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
Mesenchymal Stem Cell (MSC) therapy3 doses of 5 million MSC will be administered	Biological	Mesenchymal Stem Cell (MSC) therapy

Primary outcome

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

3 secondary outcomes

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
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
Incidence of BPD and PH in very low birth weight babies treated with MSC
Time frame: 24 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
Individual participant dataSharing planned: No

Related trials for Bronchopulmonary Dysplasia

Recruiting
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 recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
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

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. This study is not recruiting at the moment.

Maria Jesus del Cerro, PhD principal investigator

IRYCIS. Hospital Universitario Ramón y Cajal. Madrid. Spain

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02443961.

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 17 Mar 2025.