Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates

Nutrition Clinical Trial

— ACBMNC  

Official title:

Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05138276
• Other study ID #: Guangdong Women and Children H
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Guangdong Women and Children Hospital
• Contact: Jiayu Miao, MD
• Phone: 13560324100
• Email: sara930924[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Weeks to 32 Weeks

Eligibility

Inclusion Criteria: (1) born at the study hospital; (2) singleton birth; (3) 26<GA <32 weeks; (4) free of severe congenital anomalies or genetic syndromes;

Exclusion criteria: (1) mothers with clinical chorioamnionitis; (2) the mother was opsitive for hepatitis B (HBsAg and/or HBeAg), hepatitis C (anti-HCV), syphilis, HIV (anti-HIV-1 and -2), and IgM against cytomegalovirus, rubella, toxoplasma, and herpes simplex viruses; (3) consent was not obtained from the parents or guardians; and (4) after processing, UCB cells were not available.

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Growth and Development
• Neonatal Necrotizing Enterocolitis
• Nutrition
• Premature Birth
• Preterm Infants

Intervention

Other:
• Autologous Umbilical Cord Blood Mononuclear Cells Therapy
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for prevention of NEC

Drug:
• 0.9% Sodium Chloride
0.9% Sodium Chloride in control group

Locations

Country	Name	City	State
China	Jie Yang	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Women and Children Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Ballen KK, Gluckman E, Broxmeyer HE. Umbilical cord blood transplantation: the first 25 years and beyond. Blood. 2013 Jul 25;122(4):491-8. doi: 10.1182/blood-2013-02-453175. Epub 2013 May 14. Review. — View Citation

Mezey É, 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of Necrotizing enterocolitis in hospitalization	NEC rate	up to one year
Secondary	The severity of Necrotizing enterocolitis	severe NEC	up to one year
Secondary	The occurrence of feeding intolerance	Other outcomes	up to one year
Secondary	The occurrence of other intestinal disease	Other outcomes	up to one year