Systemic Sclerosis (SSc)Phase 1/2HS_SW01NCT07535931
Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Systemic Sclerosis
A Phase 1/2 study testing HS_SW01 cells injection in people with Systemic Sclerosis (SSc), run by Shenzhen Huishan Biotechnology Co., Ltd..
Trial summary
The goal of this clinical trial is to evaluate the safety and tolerability of human umbilical cord mesenchymal stem cell injection(HS_SW01 Cells injection) in patients with systemic sclerosis, and to further explore its pharmacokinetics(PK), immunological profile and preliminary efficacy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Sclerosis (SSc)
- What is being tested?
- HS_SW01 cells injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2026to 31 Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signed informed consent form.
- Age 18 to 65 years, inclusive, male or female.
- Diagnosis of systemic sclerosis (SSc) according to the 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria.
- Diagnosis of diffuse cutaneous systemic sclerosis at screening, with disease duration ≤5 years (disease onset defined as the time of initial SSc diagnosis).
- Prior treatment with at least two of the following: corticosteroids, immunosuppressants, or biologic agents, and a modified Rodnan skin score (mRSS) between 10 and 30, inclusive.
- Female subjects must meet one of the following:
- Of non-childbearing potential, defined as at least one year postmenopausal or surgically sterilized; or
- Of childbearing potential and agree to use effective contraception from the signing of informed consent through at least 6 months after the last dose of study drug, with a negative serum pregnancy test at screening.
Who cannot join
- At screening, the patient's percent predicted forced vital capacity (FVC) is <50%.
- Previously diagnosed with moderate or severe pulmonary arterial hypertension, or systolic pulmonary artery pressure >45 mmHg measured by echocardiography at screening.
- Presence of newly onset or worsening of pre-existing clinical symptoms requiring hospitalization as judged by the investigator prior to screening, including the following:
- ① Myocardial infarction, stroke, scleroderma renal crisis, severe intestinal disease, or uncontrolled severe hypertension (≥160/100 mmHg) with newly onset or worsening of pre-existing clinical symptoms within 6 months.
- ② Unstable ischemic heart disease, uncontrolled cardiac arrhythmia, heart failure (New York Heart Association Class III/IV), left ventricular ejection fraction <50% by echocardiography, renal insufficiency, or renovascular hypertension within 3 months.
- Presence of other autoimmune connective tissue diseases other than systemic sclerosis at screening, except for patients with secondary Sjögren's syndrome who are permitted to participate in this trial.
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- Any of the following laboratory abnormalities at screening:
- ① Hematologic abnormalities: hemoglobin <90 g/L; white blood cell count <3.0×10^9 /L; absolute neutrophil count <1.5×10^9 /L; platelet count <90×10^9 /L.
- ② Hepatic abnormalities: ALT or AST >3× upper limit of normal (ULN); total bilirubin >3× ULN.
- ③ Renal abnormalities: estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m², or any uncontrolled, clinically significant laboratory abnormality that may interfere with data interpretation or subject participation.
- Positive test for human immunodeficiency virus antibody (anti-HIV-Ab), active syphilis, active hepatitis C (positive for HCV antibody with detectable HCV-RNA), or positive for HBsAg with detectable HBV-DNA at screening; or history of severe active or recurrent bacterial, viral, fungal, parasitic, or other infections at screening.
- Receipt of inactivated or live-attenuated vaccine within 2 months prior to enrollment.
- Any of the following within 3 months prior to enrollment:
- ① Major trauma or major surgery (including joint surgery), or need for major surgery during the study period that, in the investigator's opinion, would pose an unacceptable risk to the subject.
- ② Treatment with plasmapheresis or extracorporeal photopheresis.
- ③ Participation in any other interventional clinical trial.
- Prior treatment with stem cell-based therapy less than 3 months before enrollment.
- History of any malignancy within 5 years prior to enrollment, except for adequately treated or resected basal cell carcinoma or squamous cell carcinoma of the skin, or cervical carcinoma in situ.
- Intolerance or contraindication to the study treatment, including any of the following:
- ① Allergy to albumin contained in the excipients of the investigational product.
- ② Absence of peripheral venous access.
- Heavy smoking, heavy drinking, or drug abuse within 12 months prior to screening or during the screening period:
- ① Heavy smoking defined as an average of ≥5 cigarettes per day within 3 months prior to screening.
- ② Heavy drinking defined as consumption of more than 14 units of alcohol per week within 3 months prior to screening (1 unit = 350 mL of beer, 45 mL of liquor, or 150 mL of wine).
- ③ Drug abuse defined as a history of drug addiction or drug abuse.
- Plan to father or bear children within at least 6 months following the last dose, or unwilling to use effective contraception with their partner, or plan to donate sperm or eggs.
- Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.
About this study
Official title: A Phase I/Ⅱ Clinical Trial for HS_SW01 Cells Injection in the Treatment of Systemic Sclerosis
The goal of this clinical trial is to evaluate the safety and tolerability of human umbilical cord mesenchymal stem cell injection(HS_SW01 Cells injection) in patients with systemic sclerosis, and to further explore its pharmacokinetics(PK), immunological profile and preliminary efficacy.
Participants will be required to sign the informed consent form and will only be assigned to the study and enrolled after undergoing a series of tests and meeting the inclusion and exclusion criteria of the protocol.
Read the detailed description
Systemic sclerosis (SSc) is a multisystem connective tissue disease involving the skin and internal organs. It is primarily characterized by chronic inflammation of affected tissues with varying degrees of collagen deposition (fibrosis), as well as peripheral and visceral obliterative vasculopathy. SSc is associated with high morbidity and mortality, particularly in patients with involvement of the lungs, heart, gastrointestinal tract, and kidneys. Scleroderma renal crisis, pulmonary arterial hypertension, and interstitial lung disease are the leading causes of death. Current treatments for SSc primarily focus on delaying disease progression and alleviating symptoms, however, their therapeutic effects are limited. As SSc significantly threatens patients' quality of life and survival, there is an urgent need to explore new therapeutic strategies.
Mesenchymal stem cell (MSC) therapy is a novel therapeutic approach that leverages the self-renewal and multidirectional differentiation capabilities of MSCs. When administered to specific sites of tissue injury, MSCs can differentiate into various cell types, thereby exerting therapeutic effects. Human umbilical cord mesenchymal stem cells (hUC-MSCs), a type of multipotent mesenchymal stem cells found in neonatal umbilical cord tissue, exhibit immunomodulatory and immunosuppressive properties, making them an effective and promising potential treatment for systemic sclerosis.
This clinical trial is a multicenter Phase I/II clinical trial, which includes two stages: Phase I dose-escalation and Phase II dose-expansion. The Phase I stage is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety and tolerability of HS_SW01 cells injection in patients with systemic sclerosis, to further explore its PK, immunogenicity profiles and preliminary efficacy. The Phase II dose-expansion stage is a randomized, double-blind, controlled study designed to evaluate the safety, efficacy, and changes in disease-related biomarkers of HS_SW01 cells injection in patients with systemic sclerosis.
During the Phase I, the trial includes three dose groups: 0.5×10^6 cells/kg, 1.0×10^6 cells/kg, and 2.0×10^6 cells/kg. Using a "3+3" dose-escalation design, each dose group will enroll 4 to 7 subjects in sequential order from the lowest to the highest dose level.
Eligible participants are patients with systemic sclerosis between 18 and 65 years of age inclusive, who satisfy all the inclusion criteria and do not meet any of the exclusion criteria.
- Conditions
- Systemic Sclerosis (SSc)
- Being tested
- HS_SW01 cells injection
- Keywords
- systemic sclerosis, MSC
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS_SW01 cells injectionDrug
Also called HS_SW01
A single dose of 0.5×10⁶ cells/kg of HS_SW01 cells injection will be given by intravenous infusion.
HS_SW01 cells injectionDrug
Also called HS_SW01
A single dose of 1×10⁶ cells/kg of HS_SW01 cells injection will be given by intravenous infusion.
HS_SW01 cells injectionDrug
Also called HS_SW01
A single dose of 2×10⁶ cells/kg of HS_SW01 cells injection will be given by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Low dose group | Experimental | intravenous inject MSCs Receives: Drug: HS_SW01 cells injection |
| Medium dose group | Experimental | intravenous inject MSCs Receives: Drug: HS_SW01 cells injection |
| High dose group | Experimental | intravenous inject MSCs Receives: Drug: HS_SW01 cells injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of DLT
Incidence of dose-limiting toxicities (DLTs) within 28 days following study drug administration.
Measured: Within 28 Days
Secondary outcomes (2)
Changes of the modified Rodnan Skin Score (mRSS) from baseline.
The modified Rodnan Skin Score (mRSS) is a standardized scale used to assess skin involvement in systemic sclerosis. In this study, mRSS will evaluate skin thickness in 17 body regions, with each region scored as follows: 0 = normal thickness; 1 = mild thickening; 2 = moderate thickening; 3 = severe thickening. The individual region scores are summed to obtain a total score ranging from 0 to 51 (higher scores indicate greater skin thickness). The change from baseline in total mRSS will be assessed at Week 4 and Week 12 after administration.
Measured: Baseline, Week 4, Week12
Changes of the HAQ-DI from baseline.
The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a widely used self-reported questionnaire assessing physical dysfunction and disability. The scale consists of 20 questions across 8 domains, with each question scored on a 4-point scale: 0 = without any difficulty; 1 = with some difficulty/aids or devices; 2 = with help from another person; 3 = unable to do. Higher scores indicate greater disability. In this study, the HAQ-DI will be used to assess change from baseline in total score at Week 4 and Week 12 after administration.
Measured: baseline , Week 4 , Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start10 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis (SSc)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Huishan Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Southern Medical University, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535931
- Sponsor's protocol ID
- HS_SW01-SSc
- Other IDs
- HS_SW01-SSc
- Acronym
- HS_SW01
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 21 Apr 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/Ⅱ Clinical Trial for HS_SW01 Cells Injection in the Treatment of Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT07535931
- Acronym / sponsor ID
- HS_SW01 / HS_SW01-SSc
- Conditions
- Systemic Sclerosis (SSc)
- Keywords
- systemic sclerosis, MSC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Shenzhen Huishan Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Southern Medical University, China
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Apr 2026 (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.
The goal of this clinical trial is to evaluate the safety and tolerability of human umbilical cord mesenchymal stem cell injection(HS_SW01 Cells injection) in patients with systemic sclerosis, and to further explore its pharmacokinetics(PK), immunological profile and preliminary efficacy.
Participants will be required to sign the informed consent form and will only be assigned to the study and enrolled after undergoing a series of tests and meeting the inclusion and exclusion criteria of the protocol.
Detailed description
Systemic sclerosis (SSc) is a multisystem connective tissue disease involving the skin and internal organs. It is primarily characterized by chronic inflammation of affected tissues with varying degrees of collagen deposition (fibrosis), as well as peripheral and visceral obliterative vasculopathy. SSc is associated with high morbidity and mortality, particularly in patients with involvement of the lungs, heart, gastrointestinal tract, and kidneys. Scleroderma renal crisis, pulmonary arterial hypertension, and interstitial lung disease are the leading causes of death. Current treatments for SSc primarily focus on delaying disease progression and alleviating symptoms, however, their therapeutic effects are limited. As SSc significantly threatens patients' quality of life and survival, there is an urgent need to explore new therapeutic strategies.
Mesenchymal stem cell (MSC) therapy is a novel therapeutic approach that leverages the self-renewal and multidirectional differentiation capabilities of MSCs. When administered to specific sites of tissue injury, MSCs can differentiate into various cell types, thereby exerting therapeutic effects. Human umbilical cord mesenchymal stem cells (hUC-MSCs), a type of multipotent mesenchymal stem cells found in neonatal umbilical cord tissue, exhibit immunomodulatory and immunosuppressive properties, making them an effective and promising potential treatment for systemic sclerosis.
This clinical trial is a multicenter Phase I/II clinical trial, which includes two stages: Phase I dose-escalation and Phase II dose-expansion. The Phase I stage is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety and tolerability of HS_SW01 cells injection in patients with systemic sclerosis, to further explore its PK, immunogenicity profiles and preliminary efficacy. The Phase II dose-expansion stage is a randomized, double-blind, controlled study designed to evaluate the safety, efficacy, and changes in disease-related biomarkers of HS_SW01 cells injection in patients with systemic sclerosis.
During the Phase I, the trial includes three dose groups: 0.5×10^6 cells/kg, 1.0×10^6 cells/kg, and 2.0×10^6 cells/kg. Using a "3+3" dose-escalation design, each dose group will enroll 4 to 7 subjects in sequential order from the lowest to the highest dose level.
Eligible participants are patients with systemic sclerosis between 18 and 65 years of age inclusive, who satisfy all the inclusion criteria and do not meet any of the exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose group | Experimental | Drug: HS_SW01 cells injectionintravenous inject MSCs |
| Medium dose group | Experimental | Drug: HS_SW01 cells injectionintravenous inject MSCs |
| High dose group | Experimental | Drug: HS_SW01 cells injectionintravenous inject MSCs |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily signed informed consent form.
- Age 18 to 65 years, inclusive, male or female.
- Diagnosis of systemic sclerosis (SSc) according to the 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria.
- Diagnosis of diffuse cutaneous systemic sclerosis at screening, with disease duration ≤5 years (disease onset defined as the time of initial SSc diagnosis).
- Prior treatment with at least two of the following: corticosteroids, immunosuppressants, or biologic agents, and a modified Rodnan skin score (mRSS) between 10 and 30, inclusive.
Key exclusion criteria (27 listed)
- At screening, the patient's percent predicted forced vital capacity (FVC) is <50%.
- Previously diagnosed with moderate or severe pulmonary arterial hypertension, or systolic pulmonary artery pressure >45 mmHg measured by echocardiography at screening.
- Presence of newly onset or worsening of pre-existing clinical symptoms requiring hospitalization as judged by the investigator prior to screening, including the following:
- ① Myocardial infarction, stroke, scleroderma renal crisis, severe intestinal disease, or uncontrolled severe hypertension (≥160/100 mmHg) with newly onset or worsening of pre-existing clinical symptoms within 6 months.
- ② Unstable ischemic heart disease, uncontrolled cardiac arrhythmia, heart failure (New York Heart Association Class III/IV), left ventricular ejection fraction <50% by echocardiography, renal insufficiency, or renovascular hypertension within 3 months.
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 |
|---|---|---|
| HS_SW01 cells injectionAlso: HS_SW01A single dose of 0.5×10⁶ cells/kg of HS_SW01 cells injection will be given by intravenous infusion. | Drug | Low dose group |
| HS_SW01 cells injectionAlso: HS_SW01A single dose of 1×10⁶ cells/kg of HS_SW01 cells injection will be given by intravenous infusion. | Drug | Medium dose group |
| HS_SW01 cells injectionAlso: HS_SW01A single dose of 2×10⁶ cells/kg of HS_SW01 cells injection will be given by intravenous infusion. | Drug | High dose group |
Primary outcome
The incidence of DLT
Time frame: Within 28 Days
Incidence of dose-limiting toxicities (DLTs) within 28 days following study drug administration.
2 secondary outcomes
Changes of the modified Rodnan Skin Score (mRSS) from baseline.
Time frame: Baseline, Week 4, Week12
Changes of the HAQ-DI from baseline.
Time frame: baseline , Week 4 , Week 12
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 21 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HS_SW01 cells injection in people with Systemic Sclerosis (SSc), run by Shenzhen Huishan Biotechnology Co., Ltd..
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 8 inclusion and 27 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 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of DLT (time frame: Within 28 Days). 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 21 Apr 2026.