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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
No Placebo-Only Group
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 belowSelect...
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:Select...
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
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,569 Previous Clinical Trials
4,319,560 Total Patients Enrolled
Leonard Lobo, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your lung function test shows that your ability to transfer carbon monoxide is greater than 25% of what is expected.My lung function tests have shown improvement over the last year.I have a health issue that makes it hard for me to do certain physical tests.I was hospitalized for a sudden worsening of my lung condition within the last 2 months.My lung function tests show I breathe well enough.My lung condition is confirmed as UIP without other causes.I can walk for 6 minutes without assistance.I have been diagnosed with IPF according to ATS guidelines.I can understand and have signed the consent form.I am between 50 and 80 years old.I can walk for 6 minutes without assistance.I have severe heart failure or my heart pumps less blood than normal.I have a lung condition that blocks airflow, confirmed by a special lung scan.I have viral hepatitis.I am HIV positive.I need extra oxygen when resting or more than 4L with activity.I need dialysis or hemofiltration.I have a lung condition that is not IPF but restricts my breathing.I haven't had serious lung infections or frequent IPF flare-ups in the last 2 years.I am between 50 and 80 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Low Dose LSCs (cohort 1) n = 4 planned
- Group 2: Usual Care (Cohort 1) n = 2 planned
- Group 3: High Dose LSCs (Cohort 2) n = 12 planned
- Group 4: Usual Care (Cohort 2) n = 6 planned
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Pulmonary fibrosis Patient Testimony for trial: Trial Name: NCT04262167 — Phase 1