Intrabone Cord Blood Transplantation | NCT00838019

Studies
Intrabone Cord Blood Transplantation

NCT00838019

Sponsor

Hospital Clinic of Barcelona

Status

Unknown status

Last Update Posted

Feb 6, 2009Estimated

Enrollment

10Estimated

Phase

Phase 4

Conditions

Hematological Malignancies

Interventions

Intrabone administration of umbilical cord blood

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Feb 2011Estimated

Completion Date

Feb 2011Estimated

First Submitted Date

Feb 5, 2009

First Submission Date that Met QC Criteria

Feb 5, 2009

First Posted Date

Feb 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2009

Last Update Posted Date

Feb 6, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cord blood	Experimental		Procedure: Intrabone administration of umbilical cord blood

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intrabone administration of umbilical cord blood	Procedure	Single administration	Cord blood

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Kinetics of hematopoietic engraftment		days 14, 21, 28 after administration

Secondary Outcomes

Measure	Description	Time Frame
Dynamics and chimerism of hematological engraftment		days 14, 21, 28 after administration

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Montserrat Rovira, MD	Contact	+34932275428		mrovira@clinic.ub.es

Overall Officials

Name	Affiliation	Role
Montserrat Rovira, MD	Hospital Clinic of Barcelona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BMT Unit Hematology Department Hospital Clinic	Recruiting	Barcelona	Barcelona	08036	Spain

Condition Browse Module

MeSH Terms

ID	Term
D019337	Hematologic Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided