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Clinical Trial Finder

Human Autologous Lung Stem Cell Transplant for Idiopathic Pulmonary Fibrosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 40 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04262167
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of North Carolina, Chapel Hill
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Leonard Lobo, MD
Principal Investigator Affiliation University of North Carolina, Chapel Hill
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Idiopathic Pulmonary Fibrosis and Progressive Fibrotic Interstitial Lung Disease
Arms & Interventions

Arms

Experimental: Low Dose LSCs (cohort 1) n = 4 planned

4-8 weeks following transbronchial biopsy, participants in this arm will receive 100 million Lung Spheroid Stem Cell (LSC) infusion.

No Intervention: Usual Care (Cohort 1) n = 2 planned

Patients will receive standard of care with no biopsy and no infusion. Placebo will not be used.

Experimental: High Dose LSCs (Cohort 2) n = 12 planned

4-8 weeks following transbronchial biopsy, participants in this arm will receive 200 million LSC infusion.

No Intervention: Usual Care (Cohort 2) n = 6 planned

Patients will receive standard of care with no biopsy and no infusion. Placebo will not be used.

Interventions

Biological: - Lung Spheroid Stem Cells 100 million

LSCs grown from autologous trans-bronchial biopsy specimens

Biological: - Lung Spheroid Stem Cells 200 million

LSCs grown from autologous trans-bronchial biopsy specimens

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Chapel Hill, North Carolina

Status

Recruiting

Address

University of North Carolina as Chapel Hill

Chapel Hill, North Carolina, 27514

Site Contact

Caleb Hemphill

[email protected]

984-974-2963

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