NCT00838019

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

February 6, 2009

Status Verified

February 1, 2009

Enrollment Period

2 years

First QC Date

February 5, 2009

Last Update Submit

February 5, 2009

Conditions

Hematological Malignancies

Outcome Measures

Primary Outcomes (1)

  • Kinetics of hematopoietic engraftment

    days 14, 21, 28 after administration

Secondary Outcomes (1)

  • Dynamics and chimerism of hematological engraftment

    days 14, 21, 28 after administration

Study Arms (1)

Cord blood

EXPERIMENTAL
Procedure: Intrabone administration of umbilical cord blood

Interventions

Intrabone administration of umbilical cord bloodPROCEDURE

Single administration

Cord blood

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • ECOG \> 2
  • Co-morbidities
  • HIV positive serology
  • Pregnancy or breastfeeding
  • Psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BMT Unit Hematology Department Hospital Clinic

Barcelona, Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Montserrat Rovira, MD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Montserrat Rovira, MD

CONTACT

+34932275428mrovira@clinic.ub.es

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 5, 2009

First Posted

February 6, 2009

Study Start

February 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

February 6, 2009

Record last verified: 2009-02

Locations

ES(1)