mbilical cord blood transplantation in high-risk hematological patients using stemregenin-1 expanded hematopoietic stem cells.A feasibility study focusing on engraftment and hematopoietic recovery.
- Conditions
- single cord blood transplantationstemregenin-1 expanded hematopoietic stem cellsengraftment
- Registration Number
- NL-OMON26058
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Age 18-70 years inclusive
- Diagnosis of poor-risk hematological malignancy and meeting the criteria for a MUD allo SCT
Exclusion Criteria
- Bilirubin and/or transaminases > 2.5 x normal value
- Creatinine clearance < 40 ml/min
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility as defined by, and to be achieved in ≥ 80% of (evaluable) patients:<br /><br>1. SR-1 mediated expansion, resulting in > 20-fold expansion of CD34+ cells, and<br /><br>2. effective hematopoietic (neutrophils > 0.5 x 109/L) engraftment within 30 days upon transplantation
- Secondary Outcome Measures
Name Time Method