Intrabone Cord Blood Transplantation

NCT ID: NCT00838019

Last Updated: 2009-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Hematological Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cord blood

Group Type EXPERIMENTAL

Intrabone administration of umbilical cord blood

Intervention Type PROCEDURE

Single administration

Interventions

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Intrabone administration of umbilical cord blood

Single administration

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Hospital Clinic.University of Barcelona

Principal Investigators

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Montserrat Rovira, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

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BMT Unit Hematology Department Hospital Clinic

Barcelona, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Montserrat Rovira, MD

Role: CONTACT

+34932275428

Facility Contacts

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Montserrat Rovira, MD

Role: primary

+34932275428

Other Identifiers

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TPH/SCU-IMed 01/08

Identifier Type: -

Identifier Source: org_study_id

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