Cord blood therapy in premature babies: a safety and feasibility study
Phase 1
Recruiting
- Conditions
- preterm brain injurycerebral palsyReproductive Health and Childbirth - Complications of newbornNeurological - Other neurological disorders
- Registration Number
- ACTRN12619001637134
- Lead Sponsor
- Monash Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Extreme premature infants (<28 weeks gestation)
Exclusion Criteria
Severe preterm brain injury (severe intraventricular haemorrhage, cystic periventricular leukomalacia)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety<br><br>Baby vital parameters, examinations and any adverse events in the first 48 hours after cell administration will be recorded on a specific case report form. <br><br>Adverse events could include a significant change in temperature, HR, RR, BP or a combination of these in first 24 hours of adminstration. Also, culture proven infection within first 48 hours of adminstration [Safety of autologous cell transplantation as evidenced by lack of adverse events in first 48 hours after transplantation ];Feasibility[Feasibility of access to enough cord blood in extreme premature infants and enough cord blood cells after processing ]
- Secondary Outcome Measures
Name Time Method Composite neurological and neurodevelopmental outcomes till 2 years of age<br>Standardised assessment tools (General movements, Hammersmith infant neurological examination, and Bayley's Scale of Infant Development-IV)[Continuous, till 2 years of age.<br>Regular follow up at 6,12,18, and 24 months corrected age. ];Characteristics of cord blood cells will be studied by flow cytometry, accounting for CD counts of cells. eg: CD1a, CD3, CD4, CD8, CD11b, CD11c, CD13, CD14, CD19, CD20, CD34, CD41a, CD41b, CD83, CD90, CD105 and CD133. This is a composite outcome[Once, at cord blood collection];Immune response to cell therapy based on blood tests done before and after transplantation <br>(namely IL-1b, IL-6, TNF-a and IL-10). This is a composite outcome[Day 1 post cell transplantation and 36 weeks post conceptional age]