CTD-ILDPhase 1NCT06823063
Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cells (IxCell hUC-MSC-P) in the Treatment of CTD-ILD
A Phase 1 study testing MSC in people with CTD-ILD, run by Shanghai IxCell Biotechnology Co., LTD at 1 site in China.
Trial summary
To evaluate the safety and tolerability of IxCell hUC-MSC-P in the treatment of patients with connective tissue disease-related interstitial lung disease. To evaluate the efficacy, pharmacokinetics and immunogenicity of IxCell hUC-MSC-P in the treatment of connective tissue disease-associated interstitial lung disease… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CTD-ILD
- What is being tested?
- MSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Dec 2026
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both sexes, aged 18-80 years;
- SSc diagnosed according to the 2013 American College of Rheumatology and European League Against Rheumatism (ACR/EULA) criteria:
- Pulmonary fibrosis ≥10% was confirmed by high-resolution chest computed tomography (HRCT);
- The diffusion capacity for carbon monoxide (DLco) was 30%-89% of the expected value, and progression of interstitial lung disease was found. Progression was confirmed if one of the following criteria was met:
- A decline of 10% or more in the percentage of predicted forced vital capacity (FVC%p) within 24 months (significant decline in ventilatory function) despite treatment;
- A decline of ≥5% in FVC%p + a decline of ≥15% in DLco (a decline in ventilation function + a decline in diffusion capacity) within 24 months despite treatment;
Show all 13Show fewer
- Within 24 months, high resolution CT (HRCT) showed worsening of pulmonary fibrosis + ≥5% decline in FVC%p (deterioration of lung imaging + decline in ventilatory function), despite treatment.
- Despite the treatment, 24 months reduced FVC % p + 5% or higher clinical symptoms (reduced ventilation function + symptoms);
- Worsening of pulmonary fibrosis on HRCT + worsening of clinical symptoms (worsening of lung imaging + worsening of symptoms) within 24 months despite treatment;
- Forced Vital Capacity (FVC) was greater than 40% of expected vital capacity;
- The patient was able to complete the 6-Minute Walk Test (6MWT);
- Be able to understand and complete pulmonary function test procedures.
- Fully informed experiment purposes, methods, and possible uncomfortable, willing to medicine and follow-up inspection on time, according to the requirements of plan agreed to participate in trials, and sign the informed consent.
Who cannot join
- The patients were diagnosed with other lung diseases other than SSc-ILD, such as COPD, lung abscess, lung cancer and other types of connective tissue disease-related interstitial lung disease.
- Have obvious acute lung infection requiring anti-infection treatment (treatment of 4 weeks prior to the start of the respiratory tract infection and systemic infection);
- History of severe pulmonary hypertension, including right heart failure, cardiac intubation, and parenteral administration of prostaglandin analogues;
- History of myocardial infarction or angina pectoris within 6 months before enrollment;
- Patients with 3 or more fingertip ulcers when signing the informed consent form or unable to accurately observe fingertip ulcers due to other reasons of the hand;
- Allergic to any component of the medication;
Show all 21Show fewer
- Life expectancy of less than 1 year due to diseases other than SSc;
- Planned surgical procedures during the trial;
- Has a history of scleroderma kidney crisis;
- Patients who had used glucocorticoids within 2 weeks before enrollment but could not maintain the dosage ≤10mg/ d equivalent prednisone;
- Patients who had used methotrexate within 2 months before enrollment, or failed to maintain a stable dosage while using other immunosuppressants;
- Into groups of 2 months before used anti fibrosis drug (such as pyrazole ketone, dani, cloth, etc.);
- Patients treated with rituximab, tocilizumab and mesenchymal stem cells within 2 months before enrollment;
- Patients with other systemic diseases and organ dysfunction (ALT>1.5 times upper limit of normal; Cr>1.5 times upper limit of normal; LVEF≤40%; Other progressive or uncontrolled diseases);
- Active hepatitis, tuberculosis, HIV infection;
- Patients with malignant tumors or a history of cancer;
- Pregnant or lactating women or those who have recently planned to have children and cannot take effective contraceptive measures;
- People with a history of alcohol or drug abuse;
- Enrolled in another drug trial within 3 months before enrollment;
- Unable to complete all assessors;
- And anyone who was deemed by the investigator to be ineligible for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety and Tolerability of a Single Dose of Human Umbilical Cord Mesenchymal Stem Cell Injection (IxCell hUC-MSC-P) in Patients With Connective Tissue Disease-associated Interstitial Lung Disease
To evaluate the safety and tolerability of IxCell hUC-MSC-P in the treatment of patients with connective tissue disease-related interstitial lung disease.
To evaluate the efficacy, pharmacokinetics and immunogenicity of IxCell hUC-MSC-P in the treatment of connective tissue disease-associated interstitial lung disease (CTD-ILD).
Read the detailed description
Mesenchymal stem cells (MSCs) are a kind of adult stem cells, which express CD73, CD40 and CD105 on the cell surface, but not CD34, CD45 and HLA-DR. They can self-renew in vitro culture environment and have the ability to differentiate into bone, adipose and chondrocytes.
Because of its anti-inflammatory, immunomodulatory and natural regenerative functions, it has become a potential therapeutic drug to control lung immune dysfunction and inflammatory response. MSCs can regulate the microenvironment of injured tissues by secreting anti-inflammatory factors and exert immunomodulatory ability through cell interaction. Firstly, MSCs can directly inhibit the proliferation of T cells, thereby reducing the number of T cells in the inflammatory site. Secondly, MSCs can also suppress T cell responses through paracrine effects. MSCs can secrete soluble immunosuppressive factors such as prostaglandin E2 (PEG2), transforming growth factor β (TGF-β), indole2, 3-dioxygenase (IDO) and nitric oxide (NO) to inhibit the ongoing T cell inflammatory response and promote T cell apoptosis. Thirdly, MSCs can attenuate the antigen-presenting ability of dendritic cells (DCs) by inhibiting DCS; Fourth, MSC-induced DCs showed a tolerogenic phenotype, which promoted the transformation of inflammatory M1 macrophages into immunosuppressive M2 macrophages. Fifth, in the manner described above, MSCs reduce the production of inflammatory factors (TNF-α, IL-1β, and IL-12) in DC cells and M1 macrophages, promote the production of anti-inflammatory factors IL-10 and TGF-β, and promote tissue repair and regeneration capacity. At the same time, immunotolerant DCs and M2 macrophages induce MSCs to produce human leukocyte antigen (HLA) G5, which promotes MSCS-induced Treg cells to form an anti-immune environment around the injured lung tissue.
The development of CTD-ILD is accompanied by chronic inflammation, and the use of MSCs can alleviate this inflammatory response. Some animal experiments and in vitro culture studies have also shown that MSCs can differentiate into alveolar epithelial cells and have potential regenerative treatment ability for lung diseases. By routine intravenous infusion, MSCs can be captured by the pulmonary vasculature and facilitate the treatment of lung injury. According to the above immunomodulatory and anti-inflammatory functions of MSCs, MSCs therapy can theoretically inhibit the inflammatory response of CTD-ILD and block or even reverse the process of pulmonary fibrosis in patients.
- Conditions
- CTD-ILD
- Being tested
- MSC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCBiological
a single injection dose i.v.
| Study group | Role | What they receive |
|---|---|---|
| hMSCs 5.0×10^7 | Experimental | Human umbilical cord mesenchymal stem cells（hMSCs）5.0×10^7 cells Receives: Biological: MSC |
| hMSCs 10.0×10^7 | Experimental | Human umbilical cord mesenchymal stem cells（hMSCs）10.0×10^7 cells Receives: Biological: MSC |
| hMSCs 20.0×10^7 | Experimental | Human umbilical cord mesenchymal stem cells（hMSCs）20.0×10^7 cells Receives: Biological: MSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE
Adverse events and serious adverse events.
Measured: 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks
Forced Vital Capacity（FVC）
Absolute change in FVC
Measured: 24 weeks
Secondary outcomes (9)
Forced Expiratory Volume in One Second (FEV1)
Forced expiratory volume in 1 second (FEV1)
Measured: 12 weeks, 24 weeks
Diffusing Capacity of the Lung for Carbon Monoxide (DLco)
Absolute change in carbon monoxide diffusing capacity (DLco)
Measured: 12 weeks, 24 weeks
St. George's Respiratory Questionnaire (SGRQ）
Score range: 0-100； Higher scores indicate worse health status, while lower scores indicate better health； Changes in the St George's Respiratory questionnaire (SGRQ)
Measured: 12 weeks, 24 weeks
Short Form Health Survey (SF-36)
Score range: 0-100； Higher scores indicate better health status, while lower scores indicate worse health； Changes in the Short Form Health Survey (SF-36)；
Measured: 12 weeks, 24 weeks
Modified Rodnan Skin Score(MRSS)
Score range: 0-51； Higher scores indicate worse health status, while lower scores indicate better health； Changes in the modified Rodnan Skin Score (MRSS)
Measured: 12 weeks, 24 weeks
High-resolution computed tomography (HRCT)
Pulmonary interstitial fibrosis on high-resolution computed tomography (HRCT)
Measured: 12 weeks, 24 weeks
6-MWT
Changes of oxygen saturation and walking distance in six-minute walk test (6MWT)
Measured: 12 weeks, 24 weeks
Health assessment questionnaire (HAQ)
Score range: 0-3； Higher scores indicate worse health status, while lower scores indicate better health； Changes in health assessment questionnaire (HAQ)
Measured: 12 weeks, 24 weeks
Survival
Disease progression-free survival
Measured: 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Apr 2025 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CTD-ILDStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai IxCell Biotechnology Co., LTD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- tao Ren, Doctor, Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823063
- Sponsor's protocol ID
- LC-MSC-ILD21003
- Status last verified
- Feb 2025
- First submitted
- 14 Jan 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety and Tolerability of a Single Dose of Human Umbilical Cord Mesenchymal Stem Cell Injection (IxCell hUC-MSC-P) in Patients With Connective Tissue Disease-associated Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT06823063
- Acronym / sponsor ID
- LC-MSC-ILD21003
- Conditions
- CTD-ILD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shanghai IxCell Biotechnology Co., LTDUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Feb 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.
To evaluate the safety and tolerability of IxCell hUC-MSC-P in the treatment of patients with connective tissue disease-related interstitial lung disease.
To evaluate the efficacy, pharmacokinetics and immunogenicity of IxCell hUC-MSC-P in the treatment of connective tissue disease-associated interstitial lung disease (CTD-ILD).
Detailed description
Mesenchymal stem cells (MSCs) are a kind of adult stem cells, which express CD73, CD40 and CD105 on the cell surface, but not CD34, CD45 and HLA-DR. They can self-renew in vitro culture environment and have the ability to differentiate into bone, adipose and chondrocytes.
Because of its anti-inflammatory, immunomodulatory and natural regenerative functions, it has become a potential therapeutic drug to control lung immune dysfunction and inflammatory response. MSCs can regulate the microenvironment of injured tissues by secreting anti-inflammatory factors and exert immunomodulatory ability through cell interaction. Firstly, MSCs can directly inhibit the proliferation of T cells, thereby reducing the number of T cells in the inflammatory site. Secondly, MSCs can also suppress T cell responses through paracrine effects. MSCs can secrete soluble immunosuppressive factors such as prostaglandin E2 (PEG2), transforming growth factor β (TGF-β), indole2, 3-dioxygenase (IDO) and nitric oxide (NO) to inhibit the ongoing T cell inflammatory response and promote T cell apoptosis. Thirdly, MSCs can attenuate the antigen-presenting ability of dendritic cells (DCs) by inhibiting DCS; Fourth, MSC-induced DCs showed a tolerogenic phenotype, which promoted the transformation of inflammatory M1 macrophages into immunosuppressive M2 macrophages. Fifth, in the manner described above, MSCs reduce the production of inflammatory factors (TNF-α, IL-1β, and IL-12) in DC cells and M1 macrophages, promote the production of anti-inflammatory factors IL-10 and TGF-β, and promote tissue repair and regeneration capacity. At the same time, immunotolerant DCs and M2 macrophages induce MSCs to produce human leukocyte antigen (HLA) G5, which promotes MSCS-induced Treg cells to form an anti-immune environment around the injured lung tissue.
The development of CTD-ILD is accompanied by chronic inflammation, and the use of MSCs can alleviate this inflammatory response. Some animal experiments and in vitro culture studies have also shown that MSCs can differentiate into alveolar epithelial cells and have potential regenerative treatment ability for lung diseases. By routine intravenous infusion, MSCs can be captured by the pulmonary vasculature and facilitate the treatment of lung injury. According to the above immunomodulatory and anti-inflammatory functions of MSCs, MSCs therapy can theoretically inhibit the inflammatory response of CTD-ILD and block or even reverse the process of pulmonary fibrosis in patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hMSCs 5.0×10^7 | Experimental | Biological: MSCHuman umbilical cord mesenchymal stem cells（hMSCs）5.0×10^7 cells |
| hMSCs 10.0×10^7 | Experimental | Biological: MSCHuman umbilical cord mesenchymal stem cells（hMSCs）10.0×10^7 cells |
| hMSCs 20.0×10^7 | Experimental | Biological: MSCHuman umbilical cord mesenchymal stem cells（hMSCs）20.0×10^7 cells |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Both sexes, aged 18-80 years;
- SSc diagnosed according to the 2013 American College of Rheumatology and European League Against Rheumatism (ACR/EULA) criteria:
- Pulmonary fibrosis ≥10% was confirmed by high-resolution chest computed tomography (HRCT);
- The diffusion capacity for carbon monoxide (DLco) was 30%-89% of the expected value, and progression of interstitial lung disease was found. Progression was confirmed if one of the following criteria was met:
- Forced Vital Capacity (FVC) was greater than 40% of expected vital capacity;
Key exclusion criteria (21 listed)
- The patients were diagnosed with other lung diseases other than SSc-ILD, such as COPD, lung abscess, lung cancer and other types of connective tissue disease-related interstitial lung disease.
- Have obvious acute lung infection requiring anti-infection treatment (treatment of 4 weeks prior to the start of the respiratory tract infection and systemic infection);
- History of severe pulmonary hypertension, including right heart failure, cardiac intubation, and parenteral administration of prostaglandin analogues;
- History of myocardial infarction or angina pectoris within 6 months before enrollment;
- Patients with 3 or more fingertip ulcers when signing the informed consent form or unable to accurately observe fingertip ulcers due to other reasons of the hand;
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 |
|---|---|---|
| MSCa single injection dose i.v. | Biological | hMSCs 10.0×10^7, hMSCs 20.0×10^7, hMSCs 5.0×10^7 |
Primary outcome
AE
Time frame: 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks
Adverse events and serious adverse events.
Forced Vital Capacity（FVC）
Time frame: 24 weeks
Absolute change in FVC
9 secondary outcomes
Forced Expiratory Volume in One Second (FEV1)
Time frame: 12 weeks, 24 weeks
Diffusing Capacity of the Lung for Carbon Monoxide (DLco)
Time frame: 12 weeks, 24 weeks
St. George's Respiratory Questionnaire (SGRQ）
Time frame: 12 weeks, 24 weeks
Short Form Health Survey (SF-36)
Time frame: 12 weeks, 24 weeks
Modified Rodnan Skin Score(MRSS)
Time frame: 12 weeks, 24 weeks
High-resolution computed tomography (HRCT)
Time frame: 12 weeks, 24 weeks
6-MWT
Time frame: 12 weeks, 24 weeks
Health assessment questionnaire (HAQ)
Time frame: 12 weeks, 24 weeks
Survival
Time frame: 12 weeks, 24 weeks
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 14 Feb 2025.
Related trials for CTD-ILD
Active, not recruiting
Optimizing the Follow-Up Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-2 Trial
Interstitial Lung Disease (ILD), Fibrotic Interstitial Lung Disease
RecruitingPhase 3
A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Interstitial Lung Disease (ILD) Associated With Systemic Sclerosis (SSc) and Other Connective Tissue Diseases (CTD) (BLISSconneCTD-OLE)
Connective Tissue Diseases
RecruitingPhase 3
A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease
Lung Diseases, Interstitial
RecruitingPhase 1
A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants
Systemic Lupus Erythematosus
RecruitingPhase 1/2
ADSCs Therapy in Patients With CTD-ILD
Connective Tissue Diseases, Interstitial Lung Disease
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.
tao Ren, Doctor principal investigator
Shanghai 6th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MSC in people with CTD-ILD, run by Shanghai IxCell Biotechnology Co., LTD at 1 site 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 13 inclusion and 21 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: opening soon, as of the sponsor's last update on 14 Feb 2025. 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 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?
Contact tao Ren, Doctor (021-64369181, rentao305@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE (time frame: 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks). The study lists 2 primary outcomes in all. 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 14 Feb 2025.