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Intrabone Cord Blood Transplantation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Hospital Clinic of Barcelona.
Recruitment status was:  Recruiting
Information provided by:
Hospital Clinic of Barcelona Identifier:
First received: February 5, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
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.

Condition Intervention Phase
Hematological Malignancies Procedure: Intrabone administration of umbilical cord blood Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study About Viability and Efficacy of Intrabone Administration of Umbilical Cord Blood for Allogeneic Stem Cell Transplantation

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Kinetics of hematopoietic engraftment [ Time Frame: days 14, 21, 28 after administration ]

Secondary Outcome Measures:
  • Dynamics and chimerism of hematological engraftment [ Time Frame: days 14, 21, 28 after administration ]

Estimated Enrollment: 10
Study Start Date: February 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cord blood Procedure: Intrabone administration of umbilical cord blood
Single administration


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00838019

Contact: Montserrat Rovira, MD +34932275428

BMT Unit Hematology Department Hospital Clinic Recruiting
Barcelona, Spain, 08036
Contact: Montserrat Rovira, MD    +34932275428   
Principal Investigator: Montserrat Rovira, MD         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Principal Investigator: Montserrat Rovira, MD Hospital Clinic of Barcelona
  More Information

Responsible Party: Dr. Raimundo Belenes, Chief Executive Officer, Hospital Clinic.University of Barcelona Identifier: NCT00838019     History of Changes
Other Study ID Numbers: TPH/SCU-IMed 01/08
Study First Received: February 5, 2009
Last Updated: February 5, 2009 processed this record on August 17, 2017