Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates (ACBMNC)
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|ClinicalTrials.gov Identifier: NCT05138276|
Recruitment Status : Recruiting
First Posted : November 30, 2021
Last Update Posted : April 25, 2022
Pre-clinical animal studies provide robust evidence regarding the beneficial effect of stem cells for intestinal disease.
This single-center, randomized, controlled, blinded trial assessed the effect of a single intravenous infusion of autologous cord blood MNCs (ACBMNCs) in preventing NEC in preterm neonates,and influence on growth and development.
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Necrotizing Enterocolitis Growth and Development Preterm Infants Nutrition||Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy Drug: 0.9% Sodium Chloride||Early Phase 1|
Study design and settings:
This study will be a randomized, placebo-controlled, double-blinded, single-center trial. A total of 45 singleton preterm infants (GS<33 weeks) of fulfilling the eligibility criteria will be enrolled. According to the infusion of umbilical cord blood mononuclear cells and equal dose placebo, the premature infants were divided into infusion group and control group. The two groups were matched with gender, gestational age and birth weight as stratified variables and 1:2 (the gender was the same, and the difference between gestational age and birth weight was the smallest).
Trial treatment methods: Study design and settings:
This study will be a randomized, placebo-controlled, double-blinded, single-center trial. A total of 30 pairs of monozygotic twins fulfilling the eligibility criteria will be enrolled. Subsequently, one baby of each twin will be randomly divided into the ACBMNC infusion group or control (placebo) group.
Trial treatment methods:
Soon after the preterm infant was deliveried, written consent was signed by the parents, and autologous cord blood infusion was applied to the baby in addition to routine treatment. Those assigned to the ACBMNC group received an infusion of ACBMNC . Those in control group received an infusion of a placebo solution. Informed consent before birth is signed. Preterm infants in the ACBMNC infusion group will have their umbilical cord blood collected after birth, and then their umbilical cord blood will be separated through Guangdong Province umbilical cord blood Bank to obtain mesenchymal stem cells. Within 24h after birth, ACBMNC group received an infusion of mesenchymal stem cells timely, while control (placebo) group received an infusion of a placebo solution which is normal saline with the same volume. Cell dose for all patients was targeted at 5×107 cells per kilogram.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates|
|Actual Study Start Date :||September 1, 2021|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Autologous cord blood mononuclear cells
Autologous Umbilical Cord Blood Mononuclear Cells Therapy 24 hours after birth ,dose is 50 million cells/kg
Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for prevention of NEC
Placebo Comparator: Placebo
0.9% sodium chloride infusion 24 hours after birth
Drug: 0.9% Sodium Chloride
0.9% Sodium Chloride in control group
- The occurrence of Necrotizing enterocolitis in hospitalization [ Time Frame: up to one year ]NEC rate
- The severity of Necrotizing enterocolitis [ Time Frame: up to one year ]severe NEC
- The occurrence of feeding intolerance [ Time Frame: up to one year ]Other outcomes
- The occurrence of other intestinal disease [ Time Frame: up to one year ]Other outcomes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05138276
|Contact: Jiayu Miao, MDemail@example.com|
|Guangzhou, Guangdong, China, 511400|
|Contact: Jie Yang, PHD 39151777 ext 020 firstname.lastname@example.org|
|Principal Investigator:||Jie Yang, PHD||Guangdong Women and Children Hospital|