Status:
COMPLETED
Autologous CD117+ Progenitor Cell Mobilization for Lung Transplantation
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Sanofi
Conditions:
COPD
Cystic Fibrosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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 a...
Detailed Description
The investigators have developed a new therapy utilizing a stem cell found in the bone marrow that is defined by cell surface expression of the protein "cluster of differentiation antigen 117" (CD117)...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01916577
Start Date
August 1 2013
End Date
December 1 2017
Last Update
February 8 2018
Active Locations (1)
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1
University of Colorado Hospital
Aurora, Colorado, United States, 80045