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Could your own lung cells heal COPD? a new stem cell trial aims to find out

NCT ID NCT06946953

Disease control Sponsor: Ruijin Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This study tests an experimental therapy called REGEND001 for people with moderate to severe COPD. The treatment uses a patient's own lung stem cells, collected via a bronchial brush, grown in a lab, and then infused back into the lungs. The goal is to see if it can safely improve the lungs' ability to transfer oxygen and ease symptoms. The trial involves 20 participants and follows them for 24 weeks after treatment.

What this could mean

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

Active substance
a stem cell therapy made from the patient's own lung cells, called REGEND001
What this could lead to
If successful, this could lead to a treatment that repairs lung damage in COPD patients, potentially improving breathing and quality of life beyond current symptom management.
What could go wrong
This is an early-phase trial with only 20 participants, so results may not apply to all COPD patients. The therapy involves invasive procedures and there is a risk of side effects or no benefit.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 20 people

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

Started

Mar 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

40 to 80 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: 1. Diagnosed with COPD according to the 2021 Global Initiative for Chronic Obstructive Lung Disease (GOLD); 2. Post-bronchodilator FEV1/FVC \<70%; 3. DLCO ≥20% and \<80% of predicted value. Exclusion Criteria: 1. Pregnant, breastfeeding, or planning to become pregnant within 1 year after treatment (or male participants planning for their spouse to become pregnant); 2. Positive for syphilis (TP-Ab), HIV, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies; 3. Current or past history of malignancy.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease

As listed by the trial registrant

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

Chronic obstructive pulmonary disease (COPD)

How to take part

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

  1. The places running it

    2 sites. 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

  • Ruijin Hospital Hainan Branch, Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Qionghai, Hainan, 571437, China

  • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

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