Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02999373
Other study ID # Guangdong M And C
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 1, 2018
Est. completion date January 1, 2020

Study information

Verified date October 2021
Source Guangdong Women and Children Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Rationale: Pre-clinical animal studies provide robust evidence regarding the beneficial effect of cord blood-derived mononuclear cells (MNCs) for experimental bronchopulmonary dysplasia (BPD). This single-center, non-randomized, controlled, blinded trial assessed the effect of a single intravenous infusion of autologous cord blood MNCs (ACBMNCs) in preventing BPD in very preterm neonates, a high-risk population.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date January 1, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 32 Weeks
Eligibility Inclusion Criteria: (1) born at the study hospital; (2) singleton birth; (3) GA <32 weeks; (4) free of severe congenital anomalies or genetic syndromes; (5) without clinical chorioamnionitis; (6) the mother was negative 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; (7) consent was obtained from the parents or guardians; and (8) after processing, UCB cells were available.

Study Design


Intervention

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

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 (9)

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

Ho MS, Mei SH, Stewart DJ. The Immunomodulatory and Therapeutic Effects of Mesenchymal Stromal Cells for Acute Lung Injury and Sepsis. J Cell Physiol. 2015 Nov;230(11):2606-17. doi: 10.1002/jcp.25028. Review. — View Citation

Lam HS, Cheung HM, Poon TC, Wong RP, Leung KT, Li K, Ng PC. Neutrophil CD64 for daily surveillance of systemic infection and necrotizing enterocolitis in preterm infants. Clin Chem. 2013 Dec;59(12):1753-60. doi: 10.1373/clinchem.2013.209536. Epub 2013 Sep 17. — View Citation

Lam HS, Wong SP, Liu FY, Wong HL, Fok TF, Ng PC. Attitudes toward neonatal intensive care treatment of preterm infants with a high risk of developing long-term disabilities. Pediatrics. 2009 Jun;123(6):1501-8. doi: 10.1542/peds.2008-2061. — View Citation

Leung, Kam Tong; Lam, Hugh Simon; Chan, Kathy Yuen Yee, Decreased Frequency of Circulating CD34+Hematopoietic Stem/Progenitor Cells in Preterm Infants with Late-Onset Systemic Bacterial Infection,Blood,2014.124.21

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

Strunk T, Inder T, Wang X, Burgner D, Mallard C, Levy O. Infection-induced inflammation and cerebral injury in preterm infants. Lancet Infect Dis. 2014 Aug;14(8):751-762. doi: 10.1016/S1473-3099(14)70710-8. Epub 2014 May 28. Review. — View Citation

van den Berg JP, van Zwieteren N, Westerbeek EA, Garssen J, van Elburg RM. Neonatal modulation of serum cytokine profiles by a specific mixture of anti-inflammatory neutral and acidic oligosaccharides in preterm infants. Cytokine. 2013 Oct;64(1):188-95. doi: 10.1016/j.cyto.2013.07.002. Epub 2013 Aug 2. — View Citation

Wannemuehler TJ, Manukyan MC, Brewster BD, Rouch J, Poynter JA, Wang Y, Meldrum DR. Advances in mesenchymal stem cell research in sepsis. J Surg Res. 2012 Mar;173(1):113-26. doi: 10.1016/j.jss.2011.09.053. Epub 2011 Oct 24. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary bronchopulmonary dysplasia at 36 weeks of postmenstrual age or the discharge home bronchopulmonary dysplasia rate 36 weeks of postmenstrual age or the discharge
Secondary number of patients with severe BPD in survivors severe BPD in survivors 36 weeks of postmenstrual age or the discharge
Secondary number of patients died before discharge from hospital mortality before discharge from hospital before discharge from hospital
Secondary the duration of mechanical ventilation Other outcomes before discharge from hospital
See also
  Status Clinical Trial Phase
Terminated NCT04506619 - Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
Completed NCT04936477 - Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants N/A
Recruiting NCT05285345 - Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
Completed NCT03649932 - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing Phase 1
Terminated NCT02524249 - Early Versus Late Caffeine for ELBW Newborns N/A
Completed NCT02249143 - Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants N/A
Active, not recruiting NCT01632475 - Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
Completed NCT01460576 - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt N/A
Completed NCT00419588 - Growth of Airways and Lung Tissues in Premature and Healthy Infants
Unknown status NCT00254176 - Cysteine Supplementation in Critically Ill Neonates Phase 2/Phase 3
Completed NCT00208039 - Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates N/A
Completed NCT00319956 - Trial II of Lung Protection With Azithromycin in the Preterm Infant Phase 2
Completed NCT00006401 - Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants Phase 3
Terminated NCT05030012 - Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants N/A
Completed NCT00006058 - Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns N/A
Completed NCT00005376 - Premature Birth and Its Sequelae in Women N/A
Completed NCT00011362 - Dexamethasone Therapy in VLBW Infants at Risk of CLD Phase 3
Completed NCT00004805 - Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death N/A
Completed NCT05152316 - The Baby Lung Study
Recruiting NCT04821453 - NAVA vs. CMV Crossover in Severe BPD N/A