Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Systemic Sclerosis (NCT07535931) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Systemic Sclerosis
21 participantsStarted 2026-04-10
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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:
✕. 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:
✕. 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: