Intrabone Cord Blood Transplantation

Hematological Malignancies Clinical Trial

Official title:

Pilot Study About Viability and Efficacy of Intrabone Administration of Umbilical Cord Blood for Allogeneic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00838019
• Other study ID #: TPH/SCU-IMed 01/08
• Status: Recruiting
• Phase: Phase 4
• First received: February 5, 2009
• Last updated: February 5, 2009
• Start date: February 2009
• Est. completion date: February 2011

Study information

• Verified date: February 2009
• Source: Hospital Clinic of Barcelona
• Contact: Montserrat Rovira, MD
• Phone: +34932275428
• Email: mrovira[@]clinic.ub.es
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematological Malignancies

Intervention

Procedure:
• Intrabone administration of umbilical cord blood
Single administration

Locations

Country	Name	City	State
Spain	BMT Unit Hematology Department Hospital Clinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinetics of hematopoietic engraftment		days 14, 21, 28 after administration	No
Secondary	Dynamics and chimerism of hematological engraftment		days 14, 21, 28 after administration	No