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

• Status: Not yet recruiting
• Trial end date: 2021-03-01
• Target enrollment: 300
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong Women and Children Hospital

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