Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Long Term Follow Up Protocol for NiCord®/CordIn™ Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02039557
Recruitment Status : Recruiting
First Posted : January 17, 2014
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Gamida Cell ltd

Brief Summary:
This is an observational study that will monitor clinical outcomes of patients who have received a NiCord®/CordIn™ transplant as part of a GC clinical interventional study and meet the eligibility criteria for this Long Term Follow Up study.

Condition or disease Intervention/treatment
Patients Transplanted With NiCord/CordIn Genetic: NiCord®/CordIn™

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long Term Follow Up for Patients Who Have Received Allogeneic Stem Cell Transplantation of NiCord®/CordIn™, Umbilical Cord Blood-derived Ex Vivo Expanded Stem and Progenitor Cells
Study Start Date : March 2014
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Group/Cohort Intervention/treatment
NiCord®/CordIn™ transplanted
Anyone who signed the consent for this study received a NiCord®/CordIn™ infusion as part of a GC clinical interventional study, and completed the interventional study Day 365 status assessment.
Genetic: NiCord®/CordIn™



Primary Outcome Measures :
  1. long term sustained chimerism of NiCord®/CordIn™ transplantation [ Time Frame: 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
NiCord® (ages 12-65)/CordIn™ (ages 2-25) transplanted patients
Criteria

Inclusion Criteria

  • Anyone who has received a NiCord®/CordIn™ transplant, completed study specific follow up, and has signed the consent for this study.

Exclusion Criteria

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039557


Contacts
Layout table for location contacts
Contact: Kelly Myers +972-2-659-5631 clinicaltrials@gamida-cell.com

Locations
Layout table for location information
United States, California
UCSF Benioff Children's Hospital Recruiting
Oakland, California, United States, 94609
Contact: Mark Walters, MD         
Principal Investigator: Mark Walters, MD         
United States, Illinois
Loyola University, Cardinal Bernardin Cancer Center Not yet recruiting
Maywood, Illinois, United States, 60153
Contact: Patrick Stiff, MD    708-327-3216    pstiff@lumc.edu   
Principal Investigator: Patrick Stiff, MD         
United States, Kansas
University of Kansas Cancer Center Not yet recruiting
Westwood, Kansas, United States, 66205
Contact: Joseph McGuirk, MD    913-945-6591    jmcguirk@kumc.edu   
Principal Investigator: Joseph McGuirk, MD         
United States, Massachusetts
Dana-Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Corey Cutler, MD    617-851-2852    cscutler@partners.org   
Principal Investigator: Corey Cutler, MD         
United States, Minnesota
University of Minnesota Masonic Cancer Center Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: John Wagner, MD    612-626-2961    wagne002@umn.edu   
Principal Investigator: John Wagner, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Mitch Horwitz, MD    919-668-1045    mitchell.horwitz@duke.edu   
Principal Investigator: Mitch Horwitz, MD         
United States, Ohio
Cleveland Clinic Children's Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Rabi Hanna, MD    216-444-0663    Hannar2@ccf.org   
Principal Investigator: Rabi Hanna, MD         
United States, Tennessee
Vanderbilt Recruiting
Nashville, Tennessee, United States, 37240
Contact: Madan Jagasia, MD    615-936-8422      
Principal Investigator: Madan Jagasia, MD         
Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3503 AB
Contact: Jaap Jan Boelens, MD    +31-88-7554003      
Principal Investigator: Jaap Jan Boelens, MD         
Singapore
National University Cancer Institute Not yet recruiting
Singapore, Singapore, 119074
Contact: Liang Piu Koh, MD    (65) 6779 5555    liang_piu_koh@nuhs.edu.sg   
Principal Investigator: Liang Piu Koh, MD         
Singapore General Hospital Not yet recruiting
Singapore, Singapore, 169608
Contact: William Hwang Ying Khee, MD    6222 3322    william.hwang.y.k@singhealth.com.sg   
Principal Investigator: William Hwang Ying Khee, MD         
Spain
University Hospital Vall D'Hebron Recruiting
Barcelona, Spain, 08035
Contact: David Valcárcel, MD    +34-93-489-30-00 ext 6417    dvalcarcel.vhebron@me.com   
Principal Investigator: David Valcárcel, MD         
Hospital Universitario La Fe Recruiting
Valencia, Spain, 46009
Contact: Guillermo Sanz, MD    +34 (96) 386-2709      
Principal Investigator: Guillermo Sanz, MD         
Sponsors and Collaborators
Gamida Cell ltd

Layout table for additonal information
Responsible Party: Gamida Cell ltd
ClinicalTrials.gov Identifier: NCT02039557     History of Changes
Other Study ID Numbers: GC P# 04.01.020/030
First Posted: January 17, 2014    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: April 2018