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Stem Cell Therapy

Lung Stem Cell Transplant for Pulmonary Fibrosis (HALT-IPF Trial)

Phase 1

Recruiting

Led By Leonard Lobo, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Probable UIP on both imaging and surgical lung biopsy with all other etiologies for UIP excluded.

Ability to perform a 6-Minute Walk Test (6MWT) at screening

Must not have

Evidence of sustained improvement of IPF condition 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

Acute or chronic impairment (other than dyspnea) which limits the ability to comply with study requirements and procedures including the 6MWT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, 24 months

Awards & highlights

Summary

This trial is testing whether autologous (self) lung stem cells are safe and effective in treating idiopathic pulmonary fibrosis.

Who is the study for?

This trial is for adults aged 50-80 with Idiopathic Pulmonary Fibrosis (IPF), able to perform a walking test, and have specific lung function measures. Excluded are those with other significant health issues like chronic heart failure, obstructive lung disease, certain infections or recent hospitalization due to IPF.

What is being tested?

The trial tests the safety and effectiveness of two doses of autologous Lung Spheroid Stem Cells (LSCs) in treating IPF. Patients' own cells will be used to grow LSCs which are then given back via IV infusion. Participants will either receive stem cells or standard care and will be monitored over two years.

What are the potential side effects?

Potential side effects aren't specified but may include reactions related to IV infusions such as discomfort at the injection site, infection risk from biopsies needed to harvest cells, and immune responses against reintroduced stem cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung condition is confirmed as UIP without other causes.

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I can walk for 6 minutes without assistance.

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I have been diagnosed with IPF according to ATS guidelines.

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I can understand and have signed the consent form.

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I am between 50 and 80 years old.

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I can walk for 6 minutes without assistance.

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I am between 50 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lung function tests have shown improvement over the last year.

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I have a health issue that makes it hard for me to do certain physical tests.

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I have severe heart failure or my heart pumps less blood than normal.

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I have a lung condition that blocks airflow, confirmed by a special lung scan.

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I have viral hepatitis.

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I am HIV positive.

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I need extra oxygen when resting or more than 4L with activity.

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I need dialysis or hemofiltration.

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I have a lung condition that is not IPF but restricts my breathing.

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I haven't had serious lung infections or frequent IPF flare-ups in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance

Number of Participants With Hematological Parameters of Potential Clinical Importance

Secondary study objectives

Change from Baseline in High Resolution CT scan Fibrosis Score (0-50)

Change from baseline in 6 minute walk test distance (meters)

Change from baseline in Diffusion capacity of the lung for carbon monoxide (DLCO)

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Low Dose LSCs (cohort 1) n = 4 plannedExperimental Treatment1 Intervention

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

Group II: High Dose LSCs (Cohort 2) n = 12 plannedExperimental Treatment1 Intervention

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

Group III: Usual Care (Cohort 1) n = 2 plannedActive Control1 Intervention

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

Group IV: Usual Care (Cohort 2) n = 6 plannedActive Control1 Intervention

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

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,543 Previous Clinical Trials

4,249,018 Total Patients Enrolled

Leonard Lobo, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Media Library

Autologous Lung Stem Cell Transplant (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04262167 — Phase 1

Pulmonary fibrosis Research Study Groups: Low Dose LSCs (cohort 1) n = 4 planned, Usual Care (Cohort 1) n = 2 planned, High Dose LSCs (Cohort 2) n = 12 planned, Usual Care (Cohort 2) n = 6 planned

Pulmonary fibrosis Clinical Trial 2023: Autologous Lung Stem Cell Transplant Highlights & Side Effects. Trial Name: NCT04262167 — Phase 1

Autologous Lung Stem Cell Transplant (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04262167 — Phase 1

Pulmonary fibrosis Patient Testimony for trial: Trial Name: NCT04262167 — Phase 1

~6 spots leftby Mar 2026

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