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Intrabone Cord Blood Transplantation

Primary Purpose

Hematological Malignancies

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Intrabone administration of umbilical cord blood

About this trial

This is an interventional treatment trial for Hematological Malignancies

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

BMT Unit Hematology Department Hospital ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cord blood

Arm Description

Outcomes

Primary Outcome Measures

Kinetics of hematopoietic engraftment

Secondary Outcome Measures

Dynamics and chimerism of hematological engraftment

Full Information

NCT ID

NCT00838019

First Posted

February 5, 2009

Last Updated

February 5, 2009

Sponsor

Hospital Clinic of Barcelona

1. Study Identification

Unique Protocol Identification Number

NCT00838019

Brief Title

Intrabone Cord Blood Transplantation

Official Title

Pilot Study About Viability and Efficacy of Intrabone Administration of Umbilical Cord Blood for Allogeneic Stem Cell Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Unknown status

Study Start Date

February 2009 (undefined)

Primary Completion Date

February 2011 (Anticipated)

Study Completion Date

February 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematological Malignancies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cord blood

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Intrabone administration of umbilical cord blood

Intervention Description

Single administration

Primary Outcome Measure Information:

Title

Kinetics of hematopoietic engraftment

Time Frame

days 14, 21, 28 after administration

Secondary Outcome Measure Information:

Title

Dynamics and chimerism of hematological engraftment

Time Frame

days 14, 21, 28 after administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Montserrat Rovira, MD

Phone

+34932275428

mrovira@clinic.ub.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Montserrat Rovira, MD

Organizational Affiliation

Hospital Clinic of Barcelona

Official's Role

Principal Investigator

Facility Information:

Facility Name

BMT Unit Hematology Department Hospital Clinic

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Montserrat Rovira, MD

Phone

+34932275428

mrovira@clinic.ub.es

First Name & Middle Initial & Last Name & Degree

Montserrat Rovira, MD

12. IPD Sharing Statement

Learn more about this trial

Intrabone Cord Blood Transplantation

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