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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
Sponsor:
Information provided by (Responsible Party):
yang jie, Guangdong Women and Children Hospital

Brief 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.


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

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. The occurrence of Necrotizing enterocolitis in hospitalization [ Time Frame: up to one year ]
    NEC rate


Secondary Outcome Measures :
  1. The severity of Necrotizing enterocolitis [ Time Frame: up to one year ]
    severe NEC

  2. The occurrence of feeding intolerance [ Time Frame: up to one year ]
    Other outcomes

  3. The occurrence of other intestinal disease [ Time Frame: up to one year ]
    Other outcomes



Information from the National Library of Medicine

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Ages Eligible for Study:   26 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

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


Contacts
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Contact: Jiayu Miao, MD 13560324100 sara930924@163.com

Locations
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China, Guangdong
Jie Yang Recruiting
Guangzhou, Guangdong, China, 511400
Contact: Jie Yang, PHD    39151777 ext 020    jasjie_yang@163.com   
Sponsors and Collaborators
Guangdong Women and Children Hospital
Investigators
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Principal Investigator: Jie Yang, PHD Guangdong Women and Children Hospital
Publications:
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Responsible Party: yang jie, Professor, Guangdong Women and Children Hospital
ClinicalTrials.gov Identifier: NCT05138276    
Other Study ID Numbers: Guangdong Women and Children H
First Posted: November 30, 2021    Key Record Dates
Last Update Posted: April 25, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by yang jie, Guangdong Women and Children Hospital:
Necrotizing enterocolitis
Preterm infants
Prevention
cord blood mononuclear cells
Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Necrotizing
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases