Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Systemic Sclerosis

NCT07535931 | Not Yet Recruiting Phase 1

• 1 other identifier: HS_SW01-SSc
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Systemic Sclerosis (SSc)

Keywords

systemic sclerosis; MSC

Outcome Measures

Primary Outcomes (1)

• The incidence of DLT

  Incidence of dose-limiting toxicities (DLTs) within 28 days following study drug administration.

  Within 28 Days

Secondary Outcomes (2)

• Changes of the modified Rodnan Skin Score (mRSS) from baseline.

  Baseline, Week 4, Week12

• Changes of the HAQ-DI from baseline.

  baseline , Week 4 , Week 12

Study Arms (3)

Low dose group

EXPERIMENTAL

intravenous inject MSCs

Drug: HS_SW01 cells injection

Medium dose group

EXPERIMENTAL

intravenous inject MSCs

Drug: HS_SW01 cells injection

High dose group

EXPERIMENTAL

intravenous inject MSCs

Drug: HS_SW01 cells injection

Interventions

HS_SW01 cells injection DRUG

A single dose of 0.5×10⁶ cells/kg of HS\_SW01 cells injection will be given by intravenous infusion.

Also known as: HS_SW01

Low dose group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shenzhen Huishan Biotechnology Co., Ltd.: lead
• Southern Medical University, China: collaborator

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 17, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share