Safety of Autologous Cord Blood Cells for Preterm Infants.

NCT03760900 | Completed Early Phase 1 DMC

• 1 other identifier: Guang dong WCH
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.

Conditions

Safety Issues; Effect of Drugs; Neonatal Death

Keywords

Autologous Umbilical Cord Blood Stem Cells; Safety; Effect; neonates; Mechanism

Outcome Measures

Primary Outcomes (3)

• Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants

  1. vital signs 2. blood gas analysis 3. blood routine 4. liver and kidney function before and after infusion will be compared

  during infusion

• Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants

  1. vital signs 2. blood gas analysis 3. blood routine 4. liver and kidney function before and after infusion will be compared

  6 hours after infusion

• Long-term safety(2-3 years follow-up after discharge) of autologous umbilical cord blood stem cell infusion for preterm infants

  1\. The growth and development curve will be drawn and compared

  2years

Study Arms (1)

infusion group

EXPERIMENTAL

Autologous Umbilical Cord Blood Stem Cells Therapy

Combination Product: Autologous Umbilical Cord Blood Stem Cells Therapy

Interventions

Autologous Umbilical Cord Blood Stem Cells Therapy COMBINATION_PRODUCT

Autologous Umbilical Cord Blood Stem Cells Therapy,the dose is 5×107cells/kg, within 24 hours after birth

infusion group

Eligibility Criteria

• Age: Up to 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Inborn Infants admitted to the Neonatal Intensive Care Unit (NICU) of Guang Dong Women and Children's Hospital were eligible if they were: 1. Preterm: \<37 weeks gestation 2. Without congenital abnormalities; 3. Without maternal chorioamnionitis 4. had available UCB. 5.the mother was negative for hepatitis B (HBsAg and/or HBeAg) and C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) and IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Guangdong Women and Children Hospital: lead

MeSH Terms

Conditions

Perinatal Death

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• jie Yang, PHD

  Guangdong Women and Children Hospital and Healthy Institutes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: November 30, 2018
• Study Start: January 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: June 5, 2016
• Last Updated: June 2, 2020

Record last verified: 2020-05