Trial Information
Pilot Study About Viability and Efficacy of Intrabone Administration of Umbilical Cord Blood for Allogeneic Stem Cell Transplantation
Inclusion Criteria:
- Hematological malignancies
- Indication of allogenic transplantation
- No suitable donor (related/unrelated)
- No suitable cord blood unit with enough cellularity for standard transplant
- Written informed consent
Exclusion Criteria:
- ECOG > 2
- Co-morbidities
- HIV positive serology
- Pregnancy or breastfeeding
- Psychiatric illness
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Kinetics of hematopoietic engraftment
Outcome Time Frame:
days 14, 21, 28 after administration
Safety Issue:
No
Principal Investigator
Montserrat Rovira, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hospital Clinic Barcelona
Authority:
Spain: Ethics Committee
Study ID:
TPH/SCU-IMed 01/08
NCT ID:
NCT00838019
Start Date:
February 2009
Completion Date:
February 2011
Related Keywords:
- Hematological Malignancies
- Neoplasms
- Hematologic Neoplasms