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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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: