Autologous CD117+ Progenitor Cell Mobilization for Lung Transplantation
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ClinicalTrials.gov Identifier: NCT01916577 |
Recruitment Status :
Completed
First Posted : August 5, 2013
Last Update Posted : February 8, 2018
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Condition or disease | Intervention/treatment | Phase |
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COPD Cystic Fibrosis Pulmonary Fibrosis | Drug: Plerixafor mobilization of autologous CD117 stem cells | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Autologous CD117+ Progenitor Cell Mobilization for Lung Transplantation |
Study Start Date : | August 2013 |
Actual Primary Completion Date : | October 2017 |
Actual Study Completion Date : | December 2017 |

Arm | Intervention/treatment |
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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
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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
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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 |
- The number of circulating CD117+ cells per milliliter (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 ]
- The number of Plerixafor (Mozobil) related adverse events (AEs) [ Time Frame: For 30 minutes after administration, at 1 week post-Plerixafor (Mozobil) treatment and up to 1 year post treatment. ]
- 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 ]
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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): NCT01916577
United States, Colorado | |
University of Colorado Hospital | |
Aurora, Colorado, United States, 80045 |
Principal Investigator: | Todd Grazia, M.D. | The University of Colorado Denver - Anschutz Medical Campus |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT01916577 |
Other Study ID Numbers: |
12-0388 11BGF-31, Project #:2565477 ( Other Grant/Funding Number: Colorado State BDEG Grant #: 11BGF-31, Project #:2565477 ) MAMO0811-1 ( Other Identifier: Sanofi ) |
First Posted: | August 5, 2013 Key Record Dates |
Last Update Posted: | February 8, 2018 |
Last Verified: | February 2018 |
Stem Cell Mobilization Stem Cells Transplantation Autologous |
Cystic Fibrosis Pulmonary Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases |
Genetic Diseases, Inborn Infant, Newborn, Diseases Plerixafor Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |