MedDataX Logo

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

NCT ID: NCT01235468

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Umbilical Cord Blood Stem Cell Transplantation Hematological Malignancies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CB expnasion

ex-vivo expansion of cord blood for transplantation

Group Type EXPERIMENTAL

ex vivo expansion

Intervention Type BIOLOGICAL

ex-vivo expansion of cord blood for transplantation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ex vivo expansion

ex-vivo expansion of cord blood for transplantation

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role collaborator

Dr. Avichai Shimoni MD

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Avichai Shimoni MD

Dr. Avichai Shimoni, hematologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Arnon Nagler, MD

Role: PRINCIPAL_INVESTIGATOR

Chaim Sheba Medical Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SHEBA-10-7959-AN-CTIL

Identifier Type: -

Identifier Source: org_study_id