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

NCT01235468 | Withdrawn Phase 1

• 1 other identifier: SHEBA-10-7959-AN-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Umbilical Cord Blood; Stem Cell Transplantation; Hematological Malignancies

Keywords

umbilical cord blood; ex vivo expansion; engraftment; GVHD

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

  Number of patients with acute and chronic GVHD after transplantation

  1 year

Secondary Outcomes (2)

• Immunological reconstruction

  5 years

• relapse

  5 years

Study Arms (1)

CB expnasion

EXPERIMENTAL

ex-vivo expansion of cord blood for transplantation

Biological: ex vivo expansion

Interventions

ex vivo expansion BIOLOGICAL

ex-vivo expansion of cord blood for transplantation

CB expnasion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Dr. Avichai Shimoni MD: lead
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Arnon Nagler, MD

  Chaim Sheba Medical Center

  PRINCIPAL INVESTIGATOR

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 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12