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NCT04262167 · ClinicalTrials.gov registry record · Phase 1
Human Autologous Lung Stem Cell Transplant for Idiopathic Pulmonary Fibrosis
A Phase 1 study of Idiopathic Pulmonary Fibrosis and Progressive Fibrotic Interstitial Lung Disease, sponsored by University of North Carolina, Chapel Hill.
- Active
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04262167 is a Phase 1 study of Idiopathic Pulmonary Fibrosis and Progressive Fibrotic Interstitial Lung Disease that is active but no longer recruiting, run by University of North Carolina, Chapel Hill. The registered enrollment target is 24 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04262167, a Phase 1 study of Idiopathic Pulmonary Fibrosis and Progressive Fibrotic Interstitial Lung Disease, is active but no longer recruiting, sponsored by University of North Carolina, Chapel Hill.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Purpose: To demonstrate the safety and efficacy of autologous Lung Spheroid Stem Cells (LSCs) administered by intravenous infusion in patients with idiopathic pulmonary fibrosis Progressive Fibrotic Interstitial Lung Disease. Participants: Patients with Idiopathic Pulmonary Fibrosis (IPF) and Progressive Fibrotic Interstitial Lung Disease Procedures (methods): 24 patients previously diagnosed with idiopathic pulmonary fibrosis or Progressive Fibrotic Interstitial Lung Disease meeting all inclusion/exclusion criteria will be evaluated at baseline. LSCs will be grown from autologous trans-bronchial pulmonary biopsy specimens. The first group, consisting of 6 patients will be randomized after completion of the screening procedures to either a treatment group of 100 million LSCs administered via intravenous infusion or to a control group (standard care) in a 2:1 LSC to control group ratio. The second group of 18 patients will be randomized after completion of the screening procedures to either a treatment group of 200 million LSCs administered via intravenous infusion or to a control group (standard care) in a 2:1 LSC to control group ratio. Patients will be randomized using permuted blocks in a 2:1 LSC to control group ratio, providing a distribution of 8:4:12 patients among the control, low dose, and high dose groups, respectively. If the patient is randomized and 100 million LSCs are not achieved, then the patient will be analyzed separately and another patient enrolled. Intravenous infusion of LSCs will take place 4-8 weeks after the pulmonary biopsies are obtained. All patients will be followed up at months 0.5, 1, 3, 6, 9, 12, 18, and 24 after infusion to complete the safety and efficacy assessments listed herein. All patients will receive standard of care for their IPF.
Interventions
- BIOLOGICAL Lung Spheroid Stem Cells 100 million
- BIOLOGICAL Lung Spheroid Stem Cells 200 million
Study Locations (1)
North Carolina
- University of North Carolina as Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-10-22 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04262167
The ClinicalTrials.gov registry entry for NCT04262167 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Idiopathic Pulmonary Fibrosis and Progressive Fibrotic Interstitial Lung Disease appearing as the primary indexed condition, and to 2 interventions - of which Lung Spheroid Stem Cells 100 million is the first listed.
NCT04262167 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT04262167 about?
NCT04262167 is a clinical study titled "Human Autologous Lung Stem Cell Transplant for Idiopathic Pulmonary Fibrosis". Purpose: To demonstrate the safety and efficacy of autologous Lung Spheroid Stem Cells (LSCs) administered by intravenous infusion in patients with idiopathic pulmonary fibrosis Progressive Fibrotic Interstitial Lung Disease. Participants: Patients with Idiopathic Pulmonary Fibrosis (IPF) and Pro...
What is the current status of trial NCT04262167?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-10-22. Estimated completion is 2027-12.
What conditions does trial NCT04262167 study?
This clinical trial studies the following conditions: Idiopathic Pulmonary Fibrosis and Progressive Fibrotic Interstitial Lung Disease.
What interventions are being tested in trial NCT04262167?
The interventions under investigation include: Lung Spheroid Stem Cells 100 million (BIOLOGICAL), Lung Spheroid Stem Cells 200 million (BIOLOGICAL).
Who is sponsoring clinical trial NCT04262167?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04262167 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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