- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00838019
Intrabone Cord Blood Transplantation
February 5, 2009 updated by: Hospital Clinic of Barcelona
Pilot Study About Viability and Efficacy of Intrabone Administration of Umbilical Cord Blood for Allogeneic Stem Cell Transplantation
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Barcelona, Spain, 08036
- Recruiting
- BMT Unit Hematology Department Hospital Clinic
-
Contact:
- Montserrat Rovira, MD
- Phone Number: +34932275428
- Email: mrovira@clinic.ub.es
-
Principal Investigator:
- Montserrat Rovira, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cord blood
|
Single administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Kinetics of hematopoietic engraftment
Time Frame: days 14, 21, 28 after administration
|
days 14, 21, 28 after administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dynamics and chimerism of hematological engraftment
Time Frame: days 14, 21, 28 after administration
|
days 14, 21, 28 after administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Montserrat Rovira, MD, Hospital Clinic of Barcelona
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Anticipated)
February 1, 2011
Study Completion (Anticipated)
February 1, 2011
Study Registration Dates
First Submitted
February 5, 2009
First Submitted That Met QC Criteria
February 5, 2009
First Posted (Estimate)
February 6, 2009
Study Record Updates
Last Update Posted (Estimate)
February 6, 2009
Last Update Submitted That Met QC Criteria
February 5, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TPH/SCU-IMed 01/08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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