Lung stem cell infusion shows promise in early IPF trial
NCT ID NCT04262167
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests whether a person's own lung stem cells, grown from a small biopsy and given through an IV, are safe for treating idiopathic pulmonary fibrosis (IPF). Twenty-four adults with IPF will receive either a low or high dose of stem cells or standard care. The main goal is to check for side effects over two years, while also looking at lung function and scarring on CT scans.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2020
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female between the ages of 40 to 80. * Diagnosis of a Progressive Fibrotic Interstitial Lung Disease * Diagnosis of IPF based on the following criteria in accordance with American Thoracic Society (ATS) guidelines for diagnosing IPF: 1. Definite usual interstitial pneumonia (UIP) confirmed on surgical lung biopsy (SLB) with all other etiologies for UIP excluded OR High resolution CT scan (HRCT) showing definite UIP with all other etiologies for UIP excluded. 2. Probable UIP on both imaging and surgical lung biopsy with all other etiologies for UIP excluded. * Forced vital capacity (FVC) greater than 50% of predicted with a ratio of forced expiratory volume in 1 second to FVC (FEV1/FVC) greater than 0.75 (Pulmonary function tests must be completed no more than 90 days before screening). * Diffusing capacity for carbon monoxide (DLCO) greater than 25% of predicted capacity. * Ability to perform a 6-Minute Walk Test (6MWT) at screening. * Competency to understand the information given in the Human Research and Ethics Committee (HREC) approved Informed Consent Form and must sign the form prior to the initiation of any study procedures Exclusion Criteria: * Diagnosis of an interstitial lung disease (ILD) or restrictive lung disease other than IPF or Progressive Fibrotic Interstitial Lung Disease. * Obstructive lung disease as determined by evidence of airflow obstruction on HRCT or physiologic criteria including: FEV1/FVC ratio less than 0.75, Residual volume (RV) greater than 120% by plethysmography or significant (verified by radiologist) emphysema on HRCT or evidence of reactive airway disease by change in FEV1 of greater than 12% following bronchodilator challenge. * Evidence of sustained improvement lung function defined as improvement from pre-therapy pulmonary function tests (PFTs) observed with two or more successive post-therapy PFTs over the year prior to randomization. * Active or recent (less than 60 days prior to enrollment) significant respiratory tract infections, or a history of frequent (greater than 2 per year for the last 2 years) infective exacerbations of IPF. * Hospitalization within 60 days of screening for an acute exacerbation of IPF (AE-IPF). Chronic heart failure (NYHA class III/IV) or known left ventricular ejection fraction less than 45%. * Acute or chronic impairment (other than dyspnea) which limits the ability to comply with study requirements and procedures including the 6MWT. * Subject requires hemodialysis, peritoneal dialysis or hemofiltration. * Infection with HIV * Viral Hepatitis * Resting oxygen requirements or \>4 L of nasal canula oxygen needed with exertion
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of North Carolina as Chapel Hill
Chapel Hill, North Carolina, 27514, United States
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Other studies related to the condition(s) this trial covers.