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Can a Patient's own airway stem cells repair damaged lungs in COPD?

NCT ID NCT07828353

Disease control Sponsor: Regend Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing REGEND001, a therapy made from a patient's own airway basal stem cells, to see if it can improve lung function in people with chronic obstructive pulmonary disease (COPD) and emphysema. The trial enrolls adults aged 40 to 75 with moderate to severe COPD. Participants undergo a bronchoscopy to collect cells, then receive either REGEND001 or a placebo through a bronchoscopy, and are followed for one year to measure changes in lung function and symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
REGEND001, a cell therapy made from a patient's own airway basal stem cells
What this could lead to
If it works, this could offer a new way to repair lung damage in COPD and slow the decline in breathing function.
What could go wrong
The approach is still experimental, and it is not yet known whether the cells will survive, engraft, or improve lung function. The bronchoscopy procedure carries small risks like bleeding or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 102 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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, aged 40-75 years； * Diagnosed with COPD; * Post-bronchodilator FEV1/FVC \<0.7 * Emphysematous lesions demonstrated by HRCT; * Hemoglobin-corrected DLCO%predicted ≥20% and \<70%; * Post-bronchodilator FEV1%predicted ≤80%; * COPD Assessment Test (CAT) score ≥3; Exclusion Criteria: * History of ≥2 COPD exacerbations leading to hospitalization within 1 year prior to screening, or a COPD exacerbation leading to hospitalization within 2 months prior to screening; * Current or previous history of malignancy; * An assessed life expectancy of \<1 year; * Respiratory tract infection or systemic infection requiring treatment, or severe localized infection within 4 weeks prior to screening; * History of invasive or non-invasive mechanical ventilation within 4 weeks prior to screening; * Diagnosis of pneumonia within 3 months prior to screening; * Abnormal coagulation function affecting the safety of fiberoptic bronchoscopy procedures at screening; * Subjects requiring long-term maintenance anticoagulant therapy or antiplatelet therapy, who are unable to discontinue such medications for at least 1 week prior to cell collection and cell infusion;

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COPD (chronic obstructive pulmonary disease)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, China

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