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To study the effect and saftey of intratracheal instillation of mesenchymal stem cells for treatment BPD
This is a Phase 1 clinical trial that constitues two points cohorts with 100 participants per cohort who will receive instillation dose of mesenchymal stem cells-25 million cells/kg,with ventilation after 14 days.And the placebol will be 0.9% sodium choride. The investigator will proceed the groups during the same period.
Deographic Data and Baseline charateristics of the studied groups were collected:
Gestational age (weeks) Birth weight (g) gender Cesarean section delivery Antenatal steroids Prolonged rupture of membrane Multiple pregnancies APGAR score at 5 minutes
mesenchymal stem cels dose is 25 million cells/kg
Assessment the incidence of BPD after instillation of Mesenchymal stem cells
the adverse after instillation of Mesenchymal stem cells
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 0.9% sodium chloride intratracheal instillate on 14 days after birth |
|
| mesenchymal stem cells | Experimental | mesenchymal stem cells intratracheal instillate on 14 days after birth ,dose is 25 million cells/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesenchymal stem cells therapy | Other | mesenchymal stem cells treatement of BPD for safety and effect evaluation0.9% sodium chloride incontrol group |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of patients with BPD after instillation mesenchymal stem cells | incidence of BPD | up to 28 days after birth |
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Inclusion Criteria:
twenty-eight weeks to thirty-seven weeks prematures who need ventilaton for 14 days after birth, and the oxygen concentration is more than 30%
Exclusion Criteria:
Preterm infants with major congenital malformations, chromosomal anomalies, inborn errors of metabolism and clinical or laboratory evidence of a congenital infection
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhuxiao Ren, MD | Contact | +8613538984634 | +86 | renzhx1990@163.com |
| Jie Yang, PHD | Contact | 39151777 | 020 | jieyang0830@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jie Yang, PHD | Guangzhou, Guangdong,China,511442 | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26051681 | Result | Mezey E, Nemeth K. Mesenchymal stem cells and infectious diseases: Smarter than drugs. Immunol Lett. 2015 Dec;168(2):208-14. doi: 10.1016/j.imlet.2015.05.020. Epub 2015 Jun 4. |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 0.9% sodium chloride | Drug | 0.9% sodium chloride in control group |
|
| D017670 |
| Sodium Compounds |