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Intrabone Cord Blood Transplantation

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ClinicalTrials.gov Identifier: NCT00838019
Recruitment Status : Unknown
Verified February 2009 by Hospital Clinic of Barcelona.
Recruitment status was:  Recruiting
First Posted : February 6, 2009
Last Update Posted : February 6, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hematological Malignancies Procedure: Intrabone administration of umbilical cord blood Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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
Study Start Date : February 2009
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : February 2011

Arm Intervention/treatment
Experimental: Cord blood Procedure: Intrabone administration of umbilical cord blood
Single administration



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

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


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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

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

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 Posted: February 6, 2009    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: February 2009