Autologous CD117+ Progenitor Cell Mobilization for Lung Transplantation

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by University of Colorado, Denver
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01916577
First received: July 29, 2013
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to determine if the drug Plerixafor (Mozobil) can lead to clinically relevant efflux of CD117+ stem cells from the bone marrow to the peripheral blood of normal controls and patients awaiting lung transplantation. The investigator's hypothesis is that Plerixafor (Mozobil) will lead to significant mobilization of CD117+ stem cells to the peripheral blood.


Condition Intervention Phase
COPD
Cystic Fibrosis
Pulmonary Fibrosis
Drug: Plerixafor mobilization of autologous CD117 stem cells
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous CD117+ Progenitor Cell Mobilization for Lung Transplantation

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • The number of circulating CD117+ cells per millilitter (ml) of peripheral blood at baseline and following Plerixafor (Mozobil) treatment (change in peripheral blood CD117+ cells per ml). [ Time Frame: At baseline and at 8 hours post-Plerixafor (Mozobil) treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of Plerixafor (Mozobil) related adverse events (AEs) [ Time Frame: For 30 minutes after administation, at 1 week post-Plerixafor (Mozobil) treatment and up to 1 year post treatment. ] [ Designated as safety issue: Yes ]
  • The number of patients with Plerixafor (Mozobil) related adverse events [ Time Frame: For the first 30 minutes post administration, at 1 week post-Plerixafor (Mozobil) treatment and up to 1 year post treatment ] [ Designated as safety issue: Yes ]
  • The number of Plerixafor (Mozobil) related serious adverse events (SAEs). [ Time Frame: For the first 30 minutes post administration, at 1 week post-Plerixafor (Mozobil) treatment and up to 1 year post treatment ] [ Designated as safety issue: Yes ]
  • The number of patients with Plerixafor (Mozobil) related serious adverse events (SAEs) [ Time Frame: For the first 30 minutes post administration, at 1 week post-Plerixafor (Mozobil) treatment and up to 1 year post treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: August 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Plerixafor (Mozobil) Control Arm
Plerixafor mobilization of autologous CD117 stem cells: Plerixafor will be given at 240mcg/kg subcutaneously once to 5 normal control patients (volunteers) at time zero with blood collected for flow cytometric analysis for CD117+ peripheral blood cells prior to the dose and then again 8 hours after the dose
Drug: Plerixafor mobilization of autologous CD117 stem cells
Peripheral mobilization of autologous CD117+ stem cells from the bone marrow in patients awaiting lung transplantation versus normal controls
Other Name: Mozobil
Experimental: Plerixafor (Mozobil) Experimental Arm
Plerixafor mobilization of autologous CD117 stem cells: Plerixafor will be given at 240mcg/kg subcutaneously once to 5 COPD, 5 Cystic Fibrosis, and 5 Pulmonary Fibrosis patients (awaiting lung transplantation) at time zero with blood collected for flow cytometric analysis for CD117+ peripheral blood cells just prior to the dose and then again 8 hours after the dose
Drug: Plerixafor mobilization of autologous CD117 stem cells
Peripheral mobilization of autologous CD117+ stem cells from the bone marrow in patients awaiting lung transplantation versus normal controls
Other Name: Mozobil

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients on the Univ. of Colorado Lung Transplant Waiting List Age 18 to 70 years old Ability to sign and understand informed consent
  • Patients 18 years or older up to age 70 on the University of Colorado Lung Transplant Waiting List and normal control subjects will be eligible for enrollment. Patients will include those with Chronic Obstructive Lung Disease, Pulmonary Fibrosis and Cystic Fibrosis

Normal control subjects = 5

Lung Transplant waitlist patients = 15 (5 each with COPD, PF or CF to determine whether disease affects mobilization potential)

Exclusion Criteria:

  • Subject has already undergone lung transplantation.
  • Subject has a known or suspected allergy to Plerixafor.
  • Women of child-bearing age who are unwilling to use appropriate birth control to prevent becoming pregnant.
  • Subjects who have received an investigational agent or device within 30 days of administration of the study agent. For the purposes of this trial, an investigational agent or device is any which is implemented under an Investigational New Drug Application (IND).
  • Subjects with a history of Hepatitis B or C.
  • Subjects with significant anemia (HCT < 35),thrombocytopenia (Plt count <100,000/cc), leukocytosis (WBC > 12,000/cc), or leucopenia (WBC < 5,000/cc).
  • Subjects with splenomegaly.
  • Subjects unable to comply with all protocol requirements.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01916577

Contacts
Contact: Jennifer J Scheer 720-848-2255 jennifer.scheer@ucdenver.edu
Contact: Todd J Grazia, M.D. 720-480-4723 Todd.Grazia@ucdenver.edu

Locations
United States, Colorado
University of Colorado Hospital Not yet recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Todd J Grazia, M.D.         
Sub-Investigator: Martin R Zamora, M.D.         
Sponsors and Collaborators
University of Colorado, Denver
Sanofi
Investigators
Study Director: Warren H. Capell, M.D. The University of Colorado Denver - Anschutz Medical Campus
  More Information

Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01916577     History of Changes
Other Study ID Numbers: 12-0388, 11BGF-31, Project #:2565477, MAMO0811-1
Study First Received: July 29, 2013
Last Updated: August 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Stem Cell Mobilization
Stem Cells
Transplantation
Autologous

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pulmonary Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
JM 3100
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014