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Connective Tissue DiseasesPhase 1/2NCT06574581

ADSCs Therapy in Patients With CTD-ILD

A Phase 1/2 study testing ADSC01 in people with Connective Tissue Diseases and Interstitial Lung Disease, run by China Medical University Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Connective tissue disease (CTD), an autoimmune and inflammatory disease, usually accompanied by lung interstitial/alveolar inflammation and fibrosis (so called interstitial lung disease, ILD). The prevalence and mortality rate of CTD-ILD increase in recent several years. Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
ADSC01
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteTaiwan
Study dates
20 Aug 2024to 30 Nov 2027
Phase
Phase 1/2
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult subjects aged between 20 and 80 years who meet the diagnostic criteria for connective tissue diseases such as dermatomyositis, polymyositis, scleroderma, systemic lupus erythematosus, rheumatoid arthritis, or Sjogren's syndrome.
  • Subjects with refractory or progressive fibrotic interstitial lung disease: Subjects have been treated with steroids and potent immunosuppressants for more than 24 months with continued deterioration of lung function or lung lesions on CT scan (defined as a forced vital capacity (FVC) decline of more than 10% from baseline, an FVC decline of 5-10% with a diffusing capacity for carbon monoxide (DLCO) decline of more than 15% from baseline, or enlargement of lung lesions on CT scan) ; Or subjects with rapidly progressive interstitial lung disease: treated with high-dose steroids (above 0.8 mg/kg/day) and potent immunosuppressants for more than 3 months with continued deterioration of lung function or lung lesions on CT scan (defined as an FVC decline of more than 5% from baseline, a DLCO decline of more than 10% from baseline, or enlargement of lung lesions on CT scan); subjects with rapidly worsening condition: Onset of pulmonary symptoms within one month, gradual worsening of dyspnea and decreased blood oxygen levels, or enlargement of lung lesions.
  • Subjects must have a well-established family support system confirmed by interviews with the principal investigator and social worker.
  • Negative high-sensitivity urine pregnancy test before the trial.
  • Agree to use effective contraceptive measures during the trial (e.g., taking contraceptive pills or using intrauterine devices one month before the trial).

Who cannot join

  • Subjects who are unwilling to sign the informed consent form after detailed explanation by the physician.
  • Patients younger than 20 or older than 80 years who show improvement in lung function or lung lesions on CT scan after 6 months of treatment with steroids and immunosuppressants.
  • Women who are pregnant or breastfeeding, and women of childbearing age who do not use contraception.
  • Subjects with abnormal liver function (serum GOT and GPT levels more than twice the upper limit of 40 units, except those caused by inflammatory myopathy) or poor kidney function (serum creatinine levels exceeding 1.4 units).
  • Subjects with immune deficiencies such as HIV/AIDS or other specific conditions (e.g., those diagnosed with notifiable infectious diseases as per Ministry of Health announcements).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Der-Yuan Chen, M.D.;Ph.D contact

886-4-22052121 ext. 2031

dychen1957@gmail.com

Taiwan1 site, 1 recruiting

  • China Medical University Hospital

    Taichung, 404327

    Der-Yuan Chen, Doctor, 886-4-22052121 ext. 2031, dychen1957@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: Allogenic Adipose Tissue Derived-MSCs Therapy in Patients With Connective Tissue Diseases-associated Interstitial Lung Disease(CTD-ILD): Phase I/IIa Clinical Trial

Connective tissue disease (CTD), an autoimmune and inflammatory disease, usually accompanied by lung interstitial/alveolar inflammation and fibrosis (so called interstitial lung disease, ILD). The prevalence and mortality rate of CTD-ILD increase in recent several years. Although the use of corticosteroids and strong immunosuppressants can improve ILD in some patients with CTD, progressive lung fibrosis which needs lung transplantation and results in respiratory failure, even with mortality is observed. Currently, stem cell therapy is a breakthrough in the treatment of CTD-ILD, and the effective therapy with stem cells for patients with ILD have been reported.

Read the detailed description

Mesenchymal stem cells (MSCs) are adult multipotent cells with self-renewal capacity, and have immunomodulatory function. By virtue of these properties, they have an ability of tissues repairing as well as regeneration, and have immunomodulatory function through an interaction with immune cells. Compared with other MSCs, adipose tissue derived-MSC (AD-MSC) are attainable by a less invasive method, grow robustly, and have a high proliferation capacity and a low immunogenicity. Recently, AD-MSC is widely employed in the field of cardiovascular diseases and autoimmune diseases without the emergence of serious adverse events.

This is a Phase I/IIa, open-labelled (without placebo group) clinical trial to treat refractory or rapidly progressive ILD in 10 patients with CTD by intravenous transfusion with allogenic AD-MSC. After signing the informed consent, CTD-ILD patients will be enrolled in this trial, including pre-treatment evaluation, admission for intravenous transfusion with AD-MSC, and post-infusion follow-up. The initial 3 subjects will receive low-dose AD-MSC (1x10E6 cells/kg) infusion therapy only once; if no adverse events after 4 weeks, the next 4-7 subjects will receive AD-MSC (1x10E6 cells/kg) infusion therapy twice; if no adverse events after 4 weeks of the last infusion, the next 8-10 subjects will receive AD-MSC (1x10E6 cells/kg) infusion therapy three times. The major aims of this trial are to improve the outcome of CTD patients with refractory ILD or rapidly progressive ILD, and identify an optimal dose of the used AD-MSC

Being tested
ADSC01
Medical subject headings
Connective Tissue Diseases, Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADSC01Biological

    The initial 3 subjects will receive low-dose AD-MSC (1x10E6 cells/kg) infusion therapy only once; if no adverse events after 4 weeks, the next 4-7 subjects will receive medium-dose AD-MSC (1x10E6 cells/kg) infusion therapy twice; if no adverse events after 4 weeks of the last infusion, the next 8-10 subjects will receive high-dose AD-MSC (1x10E6 cells/kg) infusion therapy three times.

Study groups in NCT06574581
Study groupRoleWhat they receive
ADSC01Experimental1. Low-dose AD-MSC (1x10E6 cells/kg); 2. Medium-dose AD-MSC (2x10E6 cells/kg) 3. High-dose AD-MSC (3x10E6 cells/kg)
Receives: Biological: ADSC01

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety profile (between the first infusion of AD-MSCs and 48 weeks after the last infusion of AD-MSCs)

    1. Stable blood pressure: systolic pressure 90-120mmHg and diastolic pressure 60-80mmHg measured after resting for 10 minutes
    2. Stable pulse rate: ranges 60-100/minute after resting for 10 minutes
    3. Stable respiratory rate: ranges 12-20/minute after resting for 10 minutes
    4. Normal body temperature 35.7℃-37.9℃.
    5. Resting oxygen saturation≧90% without oxygen use.
    6. Absence of AD-MSCs infusion-related serious adverse event.

    Measured: 48 weeks

Secondary outcomes (1)

  1. Efficacy profile (between the first infusion of AD-MSCs and 48 weeks after the last infusion of AD-MSCs)

    1. Change of six-minute walking distance(6MWD): Increase of 6MWD≧5% from baseline at week 12, 8% at week 24, 10% at week 48.
    2. St. George's Respiratory Questionnaire: Change of score≧5% from baseline at week 12, 10% at week 24, 15% at week 48.
    3. Quality of life (SF-36): Increase of score≧5% from baseline at week 12, 8% at week 24, 10% at week 48.
    4. Forced vital capacity (FVC): Decrement of FVC<5% at week 12, increment ≧5% at week 24, increment ≧10% at week 48.
    5. Diffusing capacity for carbon monoxide (DLco): Decrement of DLco <5% at week 12, increment≧5% at week 24, increment≧10% at week 48
    6. The extent of ILD (interstitial lung disease) lesion in HRCT: Decrement of ILD extent≧5% at week 24, and decrement of ILD extent≧10% at week 48.

    Measured: week 48.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2024
  2. Study start20 Aug 2024
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06574581
Sponsor's protocol ID
CMUH110-REC1-042
Status last verified
May 2026
First submitted
1 Aug 2024
Last updated
13 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ADSC01 in people with Connective Tissue Diseases and Interstitial Lung Disease, run by China Medical University Hospital at 1 site in Taiwan.

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 5 inclusion and 5 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 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Der-Yuan Chen, M.D.;Ph.D (886-4-22052121 ext. 2031, dychen1957@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety profile (between the first infusion of AD-MSCs and 48 weeks after the last infusion of AD-MSCs) (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06574581.

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 13 May 2026.

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