Autologous CD117+ Progenitor Cell Mobilization for Lung Transplantation

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: Sanofi
• Treatments: JM 3100; Plerixafor

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.