Intrabone Cord Blood Transplantation

Phase 4

• Conditions: Hematological Malignancies
• Interventions: Procedure: Intrabone administration of umbilical cord blood

• Registration Number: NCT00838019
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

The purpose of this study is to evaluate the viability of intrabone administration of umbilical cord blood as allogenic transplantation for the treatment of hematologic malignancies.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-02
• Study Start: 2009-02
• Study First Submitted: 2009-02-05
• Study First Submitted QC: 2009-02-05
• Last Update Submitted: 2009-02-05
• Study First Posted: 2009-02-06
• Last Update Posted: 2009-02-06
• Primary Completion: 2011-02
• Study Completion: 2011-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cord blood	Intrabone administration of umbilical cord blood	-

Primary Outcome Measures

Name	Time	Method
Kinetics of hematopoietic engraftment	days 14, 21, 28 after administration

Secondary Outcome Measures

Name	Time	Method
Dynamics and chimerism of hematological engraftment	days 14, 21, 28 after administration

Trial Locations

Locations (1)

BMT Unit Hematology Department Hospital Clinic; 🇪🇸 Barcelona, Spain