Bronchopulmonary Dysplasia (BPD) is the most frequent disease resulting of a premature birth, 15-50% of very low birth newborns (<1500 gr.) will develop this disease. 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 oxigen, maternal corioamnionitis, insuficient pulmonary maturation etc. have an important role. These factors lead to a pathological development of the lung and pulmonary vessels, developing secondary Pulmonary Hypertension. 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 Therapy as prevention of BPD, also recently some clinical trials have tried this therapy on premature newborns with promising results.
Mesenchymal Stem Cell Therapy in patients at high risk of BPD prevents pulmonary lesions.
We have designed a Clinical Trial to evaluate the feaseability, security and eficacy of therapy with Mesenchymal Stem Cells in patients at high risk of presenting BPD.
The main objetive is to assess the feasibility and safety of mesenchymal cells´ therapy in a very low weight, premature and hight risk of BPD´s development newborn children population.
The study consists of three phases:
Phase 1: Prospective cohort study: for a period of six months a group of premature patients under 1250g and 28 weeks of gestational age (GA) will be followed from the birth to week 36 of live, moment in which the DBP diagnosis will be realized.
Samples of blood and inhaled tracheal will be collect in these patients to measure scoreboards proinflamatorios, mainly.
Phase 2: Phase I clinical trial, destined to evaluate the safety of therapy with mesenchymal cells in preventing BPD´s development in a very low weight and premature population. 3 doses of 5 millions cells per weight (kg) will be administered via intra-tracheal to newborn children under 1250 grams weight (<28 weeks living: GA) wich require mechanical ventilation 14 days from birth (+/- 2 days) with FiO2 >0.4-0.5 or continue mechanical ventilation for at least 21 days. These patients will be followed for a period of two years.
Phase 3: Phase II Clinical Trial. Having established the mesenquimal therapy´s administration safety, this phase is destined to verify the mesenchymal cells therapy´s effects by an experimental randomized study with a control group.
Will be included on this Phase all alive newborn children under 1250 grams weight and 28 weeks living (GA), which are born 1 year after Phase 2 Clinical Trial is complete and require mechanical ventilation for 14 days (+/- 2 days) with FiO2> = 0.5 or continue mechanical ventilation for at least 21 days.
Patient entry criteria
- Inclusion criteria:
Specified aboved according to the study Phase (see section “Design”).
Patient´s informed consent will be required in any case.
- Exclusion Criteria:
1. Having another concomitant congenital pathology at the time of the inclusion: lung malformations with pulmonar involvement., active pulmonary hemorrhage, severe pulmonary hypoplasia, renal malformations with systemic involvement, congenital heart disease, poly-malformation syndromes, chromosomal abnormalities.
2. Not giving the informed consent.
3. Having any severe neurological injury at the time of inclusion (interventricular hemorrhage grades III or higher).
4. Being born to an HIV-infected mother
In addition, the following criteria will be apply for Phases 2 and 3 of the Study:
1. Refractory hemodynamic instability from any cause.
2. Major surgery 72 hours before the inclusion.
3. Necrotizing enterocolitis (grade II or higher) at the time of inclusion.
If you are interested in joining the Clinical Trial PULMESCELL or need additional information, please contact:
S&H Medical Science Service
C/ Manuel Tovar 43, Bajo Dcha.
Phone: +34 91 535 71 83
Fax: +34 91 535 70 52