Phase 1 Interstitial Lung Disease Trial, Recruiting NCT07372989 Sponsor: Maule Stem Cell Research Institute, Inc. Condition: Interstitial Lung Disease
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Phase 1 Interstitial Lung Disease Trial, Recruiting

NCT07372989
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are willing and able to provide written consent to participate.
  • People who are older than 40 and younger than 90 years old at the time of signing the consent form.
  • People who have been clinically diagnosed with interstitial lung disease (ILD) before the screening stage, based on established international guidelines.
  • People whose lung function test results meet specific minimum thresholds — FVC at or above 45% of the predicted value, and DLCO at or above 30% (confirm with trial site for exact testing details).
  • People whose blood oxygen level at rest is 92% or higher, while using no more than 3 litres per minute of supplemental oxygen.
  • People whose right-sided heart pressure reading (RVSP) is below 50 mmHg, as confirmed by an ultrasound of the heart or a heart catheter procedure.
  • Women who have either had a surgical procedure that prevents pregnancy or have been through menopause for more than one year.

Who may not be able to join:

  • People whose CT scan or lung biopsy results do not match a diagnosis of IPF (a specific type of Ilung disease).
  • People who are unable to complete the required study assessments, such as breathing tests, CT scans, blood draws, or written questionnaires.
  • People who are currently taking, or have taken within the past four weeks, any medication, treatment, or experimental therapy for ILD — except for oxygen therapy or pulmonary rehabilitation.
  • People who are currently listed, or expected to be listed in the future, for any organ transplant.
  • People whose screening blood test results fall outside acceptable ranges, including low red blood cell levels, low white blood cell count, low platelet count, or abnormal liver or clotting markers (confirm with trial site for specific values).
  • People with serious other health conditions that, in the treating doctor's judgement, could affect their safety or ability to complete the study — including but not limited to HIV, advanced liver or kidney failure, severe heart failure, recent heart attack, unstable chest pain, heart bypass surgery within the last six months, or severe airflow obstruction in the lungs.
  • People with any other condition that, in the treating doctor's judgement, could affect safety or the ability to complete the study.
  • People who have previously received an organ transplant.
  • People who have had a cancer diagnosis within the past two and a half years — although people treated for certain skin cancers (basal cell, squamous cell) or cervical cancer may still be considered eligible (confirm with trial site).
  • People with a non-lung condition that is expected to limit life expectancy to less than one year.
  • People with a history of drug or alcohol misuse within the past 24 months.
  • People whose blood tests show the presence of HIV, hepatitis B, or active hepatitis C infection.
  • People who are currently participating, or have participated within the past 30 days, in another clinical trial of an investigational treatment or device.
  • Women who are pregnant, breastfeeding, or capable of becoming pregnant and not using effective contraception. A pregnancy blood or urine test is required at screening and within 36 hours before any injection.
  • Women whose FSH hormone level is 25.8 IU/L or higher (a hormone measurement related to reproductive status).
  • People who have a known allergy or sensitivity to a substance called dimethyl sulfoxide (DMSO).
  • People whose resting blood oxygen level is below 93% when breathing normal air at or near sea level, or below 88% when at elevations above 5,000 feet (approximately 1,524 metres).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Cynthia S. Maule, M.D., Maule Stem Cell Research Institute

Phone: 941-949-2474

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Maule Stem Cell Research Institute, Inc.
Registry
ClinicalTrials.gov
Start date
1 February 2026
Est. completion
1 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of Treatment-Emergent Adverse Events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov