Clinical Research Directory

Clinical Study of UC-MSC Combined With Immunosuppressive Agents in the Treatment of Pediatric HAAA

The goal of this clinical trial is to evaluate the effectiveness of umbilical cord mesenchymal stem cells combined with standard immunosuppressive therapy in children with HAAA, and to provide a new therapeutic idea for children with HAAA. Whether UC-MSC combined with immunosuppressants can improve outcomes in children with HAAA. Whether UC-MSC is safe in the treatment of children with HAAA. Participants will: 1 Age \< 18 years old, gender is not limited; 2 Diagnosis of hepatitis related aplastic anemia according to the criteria for hepatitis related aplastic anemia; 1. The patient has a history of acute prehepatitis, and the course of hepatitis is generally less than 6 months. The main clinical manifestations are fever, jaundice, anemia, bleeding, generally no liver enlargement. 2. Routine blood test: pancytopenia, HGB \< 100 g/L; Absolute neutrophil count \< 1.5×109/L; PLT \< 100×109/L (PLT reduction must be included in case of two-series reduction). Serum aminotransferase levels were elevated at least 200 U/L and hepatitis autoantibodies were negative. 3. Bone marrow aspiration and biopsy confirmed aplastic anemia. 4. Jaundice caused by other reasons and other pancytopenia diseases (such as congenital AA, clonal diseases and autoimmune diseases, etc.) are excluded. 3 No hematopoietic stem cell transplantation (HSCT); 4 The guardian and the subject will participate voluntarily and sign the informed consent;

Autologous Mesenchymal Stromal Cells and Islet Co-transplantation in TP-IAT

This is a clinical trial for chronic pancreatitis (CP) patients undergoing total pancreatectomy with islet autotransplantation (TP-IAT). Participants will be randomized to either bone marrow-derived mesenchymal stem cells (MSCs) or control with the standard of care. Participants will be followed for one-year post-transplant.

Exploratory Study on the Efficacy and Safety of Nebulized hUC-MSC-Derived Exosomes for Non-Acute CIP

Study Objectives The primary objective of Phase II is to evaluate the percentage of lesion resolution on high-resolution computed tomography (HRCT) as assessed by independent blinded reviewers. Secondary objectives include evaluating effects on pulmonary function, exercise capacity, dyspnea, quality of life, and oxygenation, as well as comprehensively assessing safety and tolerability. Phase I focuses on determining safety, dose-limiting toxicities (DLT), and recommended Phase II dose. Study Population The target population is patients with non-acute CIP aged 18-75 years with histologically confirmed malignancy. Key inclusion criteria include: At least one cycle of immune checkpoint inhibitor (ICI) therapy and development of Grade 3-4 CIP per NCCN Guidelines V1.2025 Standard glucocorticoid treatment for ≥4 weeks, with current dose \<20 mg/day prednisone equivalent or discontinued Persistent residual CIP lesions on HRCT without significant improvement in the past 4 weeks ECOG PS 0-1 and stable primary tumor for ≥6 months Effective contraception during the study and for 360 days after last dosing Key exclusion criteria include: Concomitant use of pirfenidone, nintedanib, or other antifibrotic agents Inability to perform pulmonary function tests or tolerate nebulization Unresolved interstitial lung disease from radiotherapy or targeted therapy Severe cardiac, hepatic, renal, or hematological dysfunction Organ transplantation, severe immunodeficiency, active epilepsy, or severe allergic status Other investigational drug use within 28 days Study Design and Sample Size Phase I: 9-18 subjects, open-label, dose-escalation design to evaluate DLT and safety Phase II: 40 subjects, randomized, double-blind, placebo-controlled design Study Endpoints Phase I Primary Endpoints Incidence of DLT Incidence of adverse events (AE) and serious adverse events (SAE) Phase II Primary Endpoint Percentage of HRCT lesion resolution at Weeks 4, 12, and 24, assessed by independent blinded reviewers Secondary Endpoints Pulmonary function: FVC%, TLC, RV, FRC, DLCO Functional and symptomatic measures: 6MWD, mMRC dyspnea score, SGRQ, LCQ Oxygenation: PaO₂, A-aDO₂, oxygenation index Exploratory Endpoints Dynamic changes in serum biomarkers: KL-6, cytokines (IL-1β, IL-6, IL-10), immune cell subsets (Tregs, Th1/Th17) Safety Assessments Monitoring of AEs/SAEs graded by CTCAE v5.0 and causality assessment Physical examination, vital signs, SpO₂, 12-lead ECG Laboratory tests: CBC, biochemistry, coagulation, urinalysis, CRP, ESR Study Termination Rules Overall Study Termination Successful completion after all 40 subjects finish 24-week follow-up and database lock Occurrence of unexpected serious or unacceptable safety risks Demonstration of overwhelming efficacy or futility Sponsor termination due to slow enrollment, funding, or major protocol deviations Regulatory or ethics committee requirements Individual Subject Discontinuation Development of DLT or severe hypersensitivity Rapid CIP progression (e.g., \>50% radiological worsening) Tumor progression or clinical deterioration Withdrawal of informed consent Poor compliance unresponsive to intervention Loss to follow-up or death Investigator judgment of inappropriateness for continued participation Study Timeline Preparation and initiation: January 2026 - May 2026 Phase I/II enrollment: June 2026 - May 2027 Treatment and follow-up (overlapping with enrollment): through June 2028 Database lock and statistical analysis: July 2028 - August 2028 Study closeout: August 2028 - December 2028

Expanded Access Multi-Patient Experimental Treatment Involving Allogeneic Human Mesenchymal Stem Cells (hMSCs) in Subjects With Acute Ischemic Stroke (EXPAND)

The purpose of this study is to use an intravenous infusion of allogeneic human mesenchymal stem cells (Allo-hMSCs) to treat an acute ischemic stroke condition.

Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in Vitiligo

This study evaluates whether exosomes derived from human umbilical cord mesenchymal stem cells (hUMSCs-Exo) are safe and effective for treating vitiligo in adults. Vitiligo is a skin condition that causes white patches due to loss of pigment-producing cells. Current treatments have limitations, especially for patients with active disease who require oral steroids with significant side effects. This study is a single-center, randomized, controlled trial enrolling 96 adults aged 18 to 65 years with non-segmental vitiligo. Participants are divided into two groups based on disease activity: progressive vitiligo (new patches appearing or existing patches expanding in the past 3 months) and stable vitiligo (no changes in the past year). For progressive vitiligo, participants are randomly assigned to either: Experimental group: hUMSCs-Exo given by intravenous infusion every 2 weeks for 5 sessions, plus tacrolimus ointment and narrowband UVB light therapy, or Control group: oral prednisone (a standard steroid treatment) plus tacrolimus ointment and narrowband UVB light therapy For stable vitiligo, participants are randomly assigned to either: Experimental group: hUMSCs-Exo given by local injection into the white patches every 2 weeks for 5 sessions, plus tacrolimus ointment and narrowband UVB light therapy, or Control group: tacrolimus ointment plus narrowband UVB light therapy alone The treatment period lasts 12 weeks, with follow-up visits continuing to 24 weeks. The main outcome measures include improvement in skin repigmentation measured by the Vitiligo Area Scoring Index (VASI), changes in quality of life, and safety monitoring throughout the study. This study aims to establish a standardized approach for using hUMSCs-Exo in vitiligo treatment and to explore how exosomes may work by reducing oxidative stress and regulating immune responses.

Treatment With Human Umbilical Cord-derived Mesenchymal Stromal Cells in Systemic Sclerosis

The purpose of this study is to test the safety and efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells (UCMSC) for the treatment of Systemic Sclerosis (SSc).

Mesenchymal Stromal Cells in Living Donor Kidney Transplantation

Kidney transplantation is a good treatment option for people with kidney disease. However, there is still much to learn about how to best care for the transplanted kidney and keep it functioning for a long time. Transplant recipients receive induction therapy and immunosuppression (anti-rejection) drugs to prevent their body from rejecting the new kidney. These drugs are used to prevent the immune system from attacking the transplanted kidney. This research study will evaluate the safety and activity of mesenchymal stromal stem cells (MSCs) infusion compared to saline-only infusion in reducing the immune suppression necessary to achieve optimal renal function in renal transplant recipients. All participants will receive routine care: basiliximab, tacrolimus, mycophenolate mofetil, and corticosteroids.

HUC-MSC for Treatment of High-risk HPV Infection

To evaluate the safety and initial effectiveness of human umbilical cord mesenchymal stem cells in HPV clearance.