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Safety and Efficacy of Autologous Umbilical Cord Blood Stem Cells Infusion for Preterm Infants.

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ClinicalTrials.gov Identifier: NCT03760900
Recruitment Status : Not yet recruiting
First Posted : November 30, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
yangjie, Guangdong Women and Children Hospital

Brief Summary:
This study aims to establish a multidisciplinary collaboration platform for autologous cord blood stem cell therapy in premature infants in Guangdong Province; to develop autologous cord blood collection and cell preparation operation procedures for premature infants; to conduct multi-center clinical research, to establish a safety and effectiveness evaluation system; and to explore the mechanism of action. This project will solve the bottleneck problem in the treatment of premature infants once the clinical application is successfully transformed.

Condition or disease Intervention/treatment Phase
Safety Issues Effect of Drugs Neonatal Death Drug: 0.9% Sodium-chloride Other: Autologous Umbilical Cord Blood Stem Cells Therapy Phase 2

Detailed Description:
  1. Feasibility and safety of umbilical cord blood collection and isolation in premature infants and separation of mononuclear cells. The neonatal birth cohort was established and divided into the full-term group and the preterm group according to the gestational age. The two groups were divided into the premature umbilical cord blood collection group and the premature delivery control group and the full-term cord blood collection group and the full-term control group,according to whether or not the cord blood was collected. Compare the vital signs before and after the premature umbilical cord blood collection group and the premature control group, laboratory test results, premature birth complications, and determine the safety of umbilical cord blood collection in premature infants; compare the preterm umbilical cord blood collection group and the full-term cord blood collection group to collect the umbilical cord Blood volume, CD34 content, concentration, and activity, so as to study the feasibility and safety of umbilical cord blood mononuclear cells infusion in preterm infants.
  2. Based on clinical research, formulate the collection, separation and operation process of cord blood in premature infants, form a standardized operation procedure, and promote.
  3. Conduct multi-center, randomized, controlled, single-blind clinical studies to evaluate the safety and efficacy of autologous cord blood stem cell infusion for preterm infants. Premature infants were randomly divided into treatment group and control group. The treatment group received autologous umbilical cord blood stem cell intravenous infusion, divided into different doses, different infusion time and different infusion times, respectively. The effects of dose, time and frequency were compared. Short-term safety (biological signs before and after infusion, laboratory test results before and after infusion) compared with the control group, long-term safety (2-3 years follow-up after discharge, monitoring growth curve and neuromotor development) assessment; effectiveness evaluation (Primary endpoints: pre-discharge mortality and incidence of serious complications; secondary endpoints: length of hospital stay, hospitalization costs, time to restore birth weight, respiratory support time, cycle support time, antibiotic use level and duration of use) . After determining the optimal infusion time, dose and frequency, a phase III multicenter, randomized, controlled, double-blind clinical study was performed to comprehensively assess the effectiveness of autologous cord blood stem cell infusion in the treatment of preterm infants.
  4. Explore the mechanism of cord blood stem cell therapy in premature infants. Detection of paracrine factor LL-37,ANGPTL7 levels after cord blood stem cell treatment, and its association with therapeutic effects. Further exploration of the mechanism by which the Wnt/Catenine pathway regulates the secretion of stem cells and paracrine factors.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Autologous Umbilical Cord Blood Stem Cells Infusion for Preterm Infants.
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2021

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: 0.9% Sodium-chloride
0.9% Sodium-chloride in control group

Experimental: infusion group1
Autologous Umbilical Cord Blood Stem Cells Therapy
Other: Autologous Umbilical Cord Blood Stem Cells Therapy
Autologous Umbilical Cord Blood Stem Cells Therapy,the dose is 2.5×107cells/kg, 6 hours after birth

Experimental: infusion group2
Autologous Umbilical Cord Blood Stem Cells Therapy
Other: Autologous Umbilical Cord Blood Stem Cells Therapy
Autologous Umbilical Cord Blood Stem Cells Therapy,the dose is 5×107cells/kg, 6 hours after birth

Experimental: infusion group3
Autologous Umbilical Cord Blood Stem Cells Therapy
Other: Autologous Umbilical Cord Blood Stem Cells Therapy
Autologous Umbilical Cord Blood Stem Cells Therapy,the dose is 5×107cells/kg, 24 hours after birth

Experimental: infusion group4
Autologous Umbilical Cord Blood Stem Cells Therapy
Other: Autologous Umbilical Cord Blood Stem Cells Therapy
Autologous Umbilical Cord Blood Stem Cells Therapy,the dose is 5×107cells/kg, 6 and 24 hours after birth




Primary Outcome Measures :
  1. Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants [ Time Frame: during infusion ]
    1. vital signs
    2. blood gas analysis
    3. blood routine
    4. liver and kidney function before and after infusion will be compared with the control group.

  2. Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants [ Time Frame: 6 hours after infusion ]
    1. vital signs
    2. blood gas analysis
    3. blood routine
    4. liver and kidney function before and after infusion will be compared with the control group.

  3. Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants [ Time Frame: 24 hours after infusion ]
    1. vital signs
    2. blood gas analysis
    3. blood routine
    4. liver and kidney function before and after infusion will be compared with the control group.

  4. Long-term safety(2-3 years follow-up after discharge) of autologous umbilical cord blood stem cell infusion for preterm infants [ Time Frame: 2years ]
    1. The growth and development curve will be drawn and compared between infusion and control group.

  5. Long-term safety(2-3 years follow-up after discharge) of autologous umbilical cord blood stem cell infusion for preterm infants [ Time Frame: 3years ]
    2.Assess neuromotor development with BayleyIII,the percent of BayleyIII scores≥85 will be compared between infusion and control group.


Secondary Outcome Measures :
  1. efficacy of autologous cord blood stem cell infusion for preterm infants [ Time Frame: 1 year ]
    Primary1:compare the pre-discharge mortality between infuson group and control group

  2. efficacy of autologous cord blood stem cell infusion for preterm infants [ Time Frame: 1 year ]
    Primary2.compare the incidence of serious complications between infuson group and control group.

  3. efficacy of autologous cord blood stem cell infusion for preterm infants [ Time Frame: 1year ]
    Secondary1:compare the length of hospital stay (days)between infuson group and control group.

  4. efficacy of autologous cord blood stem cell infusion for preterm infants [ Time Frame: 1year ]
    Secondary2:compare the hospitalization costs between infuson group and control group.

  5. efficacy of autologous cord blood stem cell infusion for preterm infants [ Time Frame: 1year ]
    Secondary3:compare the time(days) how long the babies restore birth weight between infuson group and control group.

  6. efficacy of autologous cord blood stem cell infusion for preterm infants [ Time Frame: 1year ]
    Secondary4:compare the respiratory support time(days) between infuson group and control group.

  7. efficacy of autologous cord blood stem cell infusion for preterm infants [ Time Frame: 1year ]
    Secondary1:compare the cycle support time(days) between infuson group and control group.

  8. efficacy of autologous cord blood stem cell infusion for preterm infants [ Time Frame: 1year ]
    Secondary1:compare the antibiotic use level and duration of use(days) between infuson group and control group.



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Ages Eligible for Study:   up to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. gestational age ≤ 28 weeks or birth weight <1500g;
  2. singleton;
  3. umbilical cord blood test and umbilical cord blood mononuclear cell number ≥ 5cells × 107 / kg;
  4. obtain written consent of parents or their guardians;

Exclusion Criteria:

  1. prenatal diagnosis of severe congenital malformations, including complex congenital heart disease, obvious structural abnormalities of the brain;
  2. maternal prenatal examination for sexually transmitted diseases or congenital teratogenic virus infections, including syphilis, AIDS, TORCH infection ;
  3. mother has clinical chorioamnionitis

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): NCT03760900


Contacts
Contact: ZhuXiao Ren, MD +8613538984634 ext +86 renzhx1990@163.com
Contact: jie Yang 39151777 ext 39151777 Jjieyang0830@163.com

Sponsors and Collaborators
Guangdong Women and Children Hospital
Investigators
Principal Investigator: jie Yang, PHD Guangdong Women and Children Hospital and Healthy Institutes

Responsible Party: yangjie, Professor, Guangdong Women and Children Hospital
ClinicalTrials.gov Identifier: NCT03760900     History of Changes
Other Study ID Numbers: Guang dong WCH
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by yangjie, Guangdong Women and Children Hospital:
Autologous Umbilical Cord Blood Stem Cells
Safety
Effect
neonates
Mechanism

Additional relevant MeSH terms:
Perinatal Death
Pregnancy Complications
Death
Pathologic Processes