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.
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).
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 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.
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.
Parallel
HS_SW01 cells injection
DrugA single dose of 0.5×10⁶ cells/kg of HS\_SW01 cells injection will be given by intravenous infusion.
HS_SW01 cells injection
DrugA single dose of 1×10⁶ cells/kg of HS\_SW01 cells injection will be given by intravenous infusion.
HS_SW01 cells injection
DrugA single dose of 2×10⁶ cells/kg of HS\_SW01 cells injection will be given by intravenous infusion.
The incidence of DLT
Incidence of dose-limiting toxicities (DLTs) within 28 days following study drug administration.
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.
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.
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Shenzhen Huishan Biotechnology Co., Ltd.
Lead sponsor
Southern Medical University, China
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
