Interstitial Lung Disease (ILD)Phase 1NCT06998706
REGEND001 Autologous Basal Layer Stem Cell Transplantation for Interstitial Lung Disease (ILD): A Translational Application Study
A Phase 1 study testing REGEND001 Autologous Basal Layer Stem Cell Suspension in people with Interstitial Lung Disease (ILD), run by Ruijin Hospital at 2 sites in China.
Trial summary
This clinical trial evaluates the safety and efficacy of REGEND001, an autologous bronchial basal layer stem cell therapy, in patients with interstitial lung disease (ILD). The treatment involves harvesting the patient's own stem cells (expressing KRT5/P63 markers), expanding them ex vivo, and administering them via… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Interstitial Lung Disease (ILD)
- What is being tested?
- REGEND001 Autologous Basal Layer Stem Cell Suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesChina
- Study dates
- 19 Jun 2025to 30 Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-75 years.
- Confirmed diagnosis of ILD (e.g., IPF, connective tissue disease-associated ILD).
- DLCO ≥30% and <80% predicted.
Who cannot join
- Pregnancy, lactation, or plans for pregnancy within 1 year.
- Active malignancy or history of malignancy.
- Positive serology for HIV, HBV, HCV, or syphilis.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Ruijin Hospital Hainan Branch, Shanghai Jiao Tong University School of Medicine
Qionghai, Hainan, 571437
Wen Su, 0898-62621907, sw11831@rjh.com
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jiayang Yan, Ph.D, 86-21-64370045, yjy19960816@163.com
About this study
This clinical trial evaluates the safety and efficacy of REGEND001, an autologous bronchial basal layer stem cell therapy, in patients with interstitial lung disease (ILD). The treatment involves harvesting the patient's own stem cells (expressing KRT5/P63 markers), expanding them ex vivo, and administering them via bronchoscopic infusion to regenerate damaged lung tissue.
- Conditions
- Interstitial Lung Disease (ILD)
- Being tested
- REGEND001 Autologous Basal Layer Stem Cell Suspension
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGEND001 Autologous Basal Layer Stem Cell SuspensionBiological
REGEND001 Autologous Basal Layer Stem Cell Suspension is an innovative cell therapy product designed for chronic structural lung diseases, such as bronchiectasis. This treatment involves harvesting regenerative stem cells (expressing KRT5/P63 markers) from the patient's own bronchial basal layer via fiberoptic bronchoscopy. After isolation, purification, and ex vivo expansion, the cells are administered as a suspension through bronchoscopic infusion into damaged lung segments.
| Study group | Role | What they receive |
|---|---|---|
| ICD patients | Experimental | Not described Receives: Biological: REGEND001 Autologous Basal Layer Stem Cell Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DLCO from baseline.
The diffusing capacity of the lungs for carbon monoxide (DLCO) is a measurement of the gas transfer capacity of lung.
Measured: Baseline, 4 weeks post treatment, 24 weeks post treatment
Secondary outcomes (4)
Change in FVC from baseline
The forced vital capacity (FVC) is a measurement of the airflow capacity.
Measured: Baseline, 4 weeks post treatment, 24 weeks post treatment
Incidence of adverse events and serious adverse events.
Measured: Through study completion, an average of 6 months
High-resolution CT (HRCT) imaging scores
Measured: Baseline, 4 weeks post treatment, 24 weeks post treatment
Quality of life (QoL) assessment via validated respiratory questionnaires
Score range: 0 to 100. Higher scores indicate a worse outcome
Measured: Baseline, 4 weeks post treatment, 24 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start19 Jun 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung Disease (ILD)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jieming QU, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998706
- Sponsor's protocol ID
- 20250515
- Status last verified
- Jul 2026
- First submitted
- 15 May 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REGEND001 Autologous Basal Layer Stem Cell Transplantation for Interstitial Lung Disease (ILD): A Translational Application Study
- ClinicalTrials.gov ID
- NCT06998706
- Acronym / sponsor ID
- 20250515
- Conditions
- Interstitial Lung Disease (ILD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial evaluates the safety and efficacy of REGEND001, an autologous bronchial basal layer stem cell therapy, in patients with interstitial lung disease (ILD). The treatment involves harvesting the patient's own stem cells (expressing KRT5/P63 markers), expanding them ex vivo, and administering them via bronchoscopic infusion to regenerate damaged lung tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICD patients | Experimental | Biological: REGEND001 Autologous Basal Layer Stem Cell Suspension |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 40-75 years.
- Confirmed diagnosis of ILD (e.g., IPF, connective tissue disease-associated ILD).
- DLCO ≥30% and <80% predicted.
Key exclusion criteria (3 listed)
- Pregnancy, lactation, or plans for pregnancy within 1 year.
- Active malignancy or history of malignancy.
- Positive serology for HIV, HBV, HCV, or syphilis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGEND001 Autologous Basal Layer Stem Cell SuspensionREGEND001 Autologous Basal Layer Stem Cell Suspension is an innovative cell therapy product designed for chronic structural lung diseases, such as bronchiectasis. This treatment involves harvesting regenerative stem cells (expressing KRT5/P63 markers) from the patient's own bronchial basal layer via fiberoptic bronchoscopy. After isolation, purification, and ex vivo expansion, the cells are administered as a suspension through bronchoscopic infusion into damaged lung segments. | Biological | ICD patients |
Primary outcome
Change in DLCO from baseline.
Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment
The diffusing capacity of the lungs for carbon monoxide (DLCO) is a measurement of the gas transfer capacity of lung.
4 secondary outcomes
Change in FVC from baseline
Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment
Incidence of adverse events and serious adverse events.
Time frame: Through study completion, an average of 6 months
High-resolution CT (HRCT) imaging scores
Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment
Quality of life (QoL) assessment via validated respiratory questionnaires
Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruijin Hospital Hainan Branch, Shanghai Jiao Tong University School of Medicine
Qionghai, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing REGEND001 Autologous Basal Layer Stem Cell Suspension in people with Interstitial Lung Disease (ILD), run by Ruijin Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in DLCO from baseline. (time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.