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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00838019
First Posted: February 6, 2009
Last Update Posted: February 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Clinic of Barcelona
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838019


Contacts
Contact: Montserrat Rovira, MD +34932275428 mrovira@clinic.ub.es

Locations
Spain
BMT Unit Hematology Department Hospital Clinic Recruiting
Barcelona, Spain, 08036
Contact: Montserrat Rovira, MD    +34932275428    mrovira@clinic.ub.es   
Principal Investigator: Montserrat Rovira, MD         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Montserrat Rovira, MD Hospital Clinic of Barcelona
  More Information

Responsible Party: Dr. Raimundo Belenes, Chief Executive Officer, Hospital Clinic.University of Barcelona
ClinicalTrials.gov Identifier: NCT00838019     History of Changes
Other Study ID Numbers: TPH/SCU-IMed 01/08
First Submitted: February 5, 2009
First Posted: February 6, 2009
Last Update Posted: February 6, 2009
Last Verified: February 2009