Autologous CD117+ Progenitor Cell Mobilization for Lung Transplantation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01916577
• Date of registration: 29/07/2013
• Prospective Registration: Yes
• Primary sponsor: University of Colorado, Denver
• Public title: Autologous CD117+ Progenitor Cell Mobilization for Lung Transplantation
• Scientific title: Autologous CD117+ Progenitor Cell Mobilization for Lung Transplantation
• Date of first enrolment: August 2013
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01916577
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Todd Grazia, M.D.
• Affiliation: The University of Colorado Denver - Anschutz Medical Campus

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Fibrosis

COPD

Cystic Fibrosis

Intervention(s)

Drug: Plerixafor mobilization of autologous CD117 stem cells

Primary Outcome(s)

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]

Secondary Outcome(s)

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 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 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 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]

Secondary ID(s)

11BGF-31, Project #:2565477

MAMO0811-1

12-0388

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi