Intrabone Cord Blood Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Hospital Clinic of Barcelona.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00838019
First received: February 5, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dynamics and chimerism of hematological engraftment [ Time Frame: days 14, 21, 28 after administration ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 5, 2009
Last Updated: February 5, 2009
Health Authority: Spain: Ethics Committee

ClinicalTrials.gov processed this record on October 30, 2014