NCT01235468

WithdrawnPhase 1

Allogenic Transplantation of Ex-vivo Expanded Cord Blood (CB...

Dr. Avichai Shimoni MD Source

Dr. Avichai Shimoni MD

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

SHEBA-10-7959-AN-CTIL

Study Type

interventional

Actual enrollment (reported)

0

Locations

0 countries

Sites

N/A

Timeline

Study Start

June 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2015

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

November 2015

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: withdrawn
Actual enrollment (reported): 0 participants
Study completion date: November 2015
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
November 2, 2010
Actual (reported)
First Posted
November 5, 2010
Actual (reported)
Study Start
June 2012
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
November 2015
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2015
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: December 3, 2015
Status Verified: December 2015
Last Update Submitted: December 1, 2015

Conditions

Hematological Malignancies Stem Cell Transplantation Umbilical Cord Blood

Keywords

umbilical cord bloodex vivo expansionengraftmentGVHD

Outcome Measures

Primary Outcomes (4)

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

Study Arms (1)

CB expnasion

EXPERIMENTAL

ex-vivo expansion of cord blood for transplantation

Biological: ex vivo expansion

Interventions

ex vivo expansionBiological

ex-vivo expansion of cord blood for transplantation

CB expnasion

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

age \> 18 years
hematological malignancy

Sponsors & Collaborators

Dr. Avichai Shimoni MD
Governmentlead
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Othercollaborator

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

Arnon Nagler, MD
Chaim Sheba Medical Center
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER GOV
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Dr. Avichai Shimoni, hematologist

Study Record Dates

First Submitted

November 2, 2010

First Posted

November 5, 2010

Study Start

June 2012

Date type not reported

This date has not been verified as actual or estimated.

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Number of patients with acute and chronic GVHD after transplantation

1 year

Secondary Outcomes (2)

Immunological reconstruction
5 years
relapse
5 years

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

November 2015

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

November 2015

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

December 3, 2015

Record last verified: 2015-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01235468
Data provider: ClinicalTrials.gov
Source updated: 2015-12-03
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:10 UTC

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (1)

CB expnasion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (2)

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (1)

CB expnasion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (2)

You may not qualify if:

Source record