Allogenic Transplantation of Ex-vivo Expanded Cord Blood... | NCT01235468

Studies
Allogenic Transplantation of Ex-vivo Expanded Cord Blood (CB)

NCT01235468

Sponsor

Dr. Avichai Shimoni MD

Status

Withdrawn

Last Update Posted

Dec 3, 2015Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Umbilical Cord Blood
Stem Cell Transplantation
Hematological Malignancies

Interventions

ex vivo expansion

Countries

Not provided

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

Dec 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

loss of support

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Nov 2015Estimated

Completion Date

Nov 2015Estimated

First Submitted Date

Nov 2, 2010

First Submission Date that Met QC Criteria

Nov 4, 2010

First Posted Date

Nov 5, 2010Estimated

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

Dec 1, 2015

Last Update Posted Date

Dec 3, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Avichai Shimoni MD, Dr. Avichai Shimoni, hematologist, Sheba Medical CenterSponsor-Investigator

Lead Sponsor

Dr. Avichai Shimoni MDOTHER_GOV

Collaborators

Name	Class
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	OTHER

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 aim of this study is to evaluate the safety profile and tolerability of infusion of cord blood cells expanded in the lab and to evaluated whether through the infusion of expanded cells it is possible to expedite engraftment time after transplantation.

Detailed Description

Stem cell transplantation is a curative approach for patients with hematological malignancies. Umbilical cord blood is a source of stem cells for transplantation in patients with no related donor. However, in adults, the number of stem cells in a single unit, may be too low to allow engraftment, and the time to engraftment may be prolonged, increasing the risks of the transplant. In this study, we expand part of the cord blood unit, in the lab, trying to increase unit size, such that it would be suitable for adults, and would allow safe engraftment.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CB expnasion	Experimental	ex-vivo expansion of cord blood for transplantation	Biological: ex vivo expansion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ex vivo expansion	Biological	ex-vivo expansion of cord blood for transplantation	CB expnasion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety	Number of patients with adverse events during infusion	1 month
engraftment	Time to engraftment	3 months
treatment-related toxicity	Type and severity of adverse events after transplantation using the NCI CTC scale	3 months
GVHD	Number of patients with acute and chronic GVHD after transplantation	1 year

Secondary Outcomes

Measure	Description	Time Frame
Immunological reconstruction	immunological reconstruction after transplantation measured by lymphocyte number and function	5 years
relapse	rate of disease recurrence

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age > 18 years
hematological malignancy
standard indication for allogeneic transplantation
expected survival time over 12 weeks
no related or unrelated donor
availability of a cord blood unit of compatible placental blood cryopreserved in at least 2 different bags; one of the two units should have a cellular content at least equal to the minimum dose of 2 x 107 nucleated cells per kilogram of body weight

Exclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status >2
Prior allogeneic transplantation
Pregnant or nursing women
Positive serology for hepatitis B or C
HIV positive
Left ventricular ejection fraction < 50%
DLCO < 50%
Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study
Treatment with other investigational drugs within 4 weeks of enrolling in this protocol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Arnon Nagler, MD	Chaim Sheba Medical Center	Principal Investigator

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

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Browse Branches

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