NCT07441720

Safety and Efficacy of Umbilical Cord Blood Therapy for Cancer Therapy-Induced Thrombocytopenia (CTIT)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single-center, open-label, single-arm clinical trial to assess the safety and efficacy of umbilical cord blood in cancer treatment-induced thrombocytopenia (CTIT) patients. It plans to recruit subjects aged 12 to 65 years old with CTIT. The study involves intravenous infusion of umbilical cord blood, with platelet transfusion as supportive therapy if necessary. The trial consists of three phases: screening (baseline assessments and enrollment), treatment (umbilical cord blood infusion), and follow-up (blood routine tests at Days 3, 7, 14, and 28 post-treatment to record platelet counts, first response time, maximum and minimum values, and calculate efficacy rates while observing changes in thrombocytopenia grading). A total of 25 subjects will be enrolled, and they will undergo evaluation for safety and efficacy based on treatment-related adverse events, GVHD incidence, and hematological improvements.

Detailed description

Umbilical cord blood infusion involves cord blood-derived hematopoietic stem cells sourced from the Umbilical Cord Blood Hematopoietic Stem Cell Bank, with HLA typing 0-3/10 matched, total nucleated cells (TNC) \>1×10\^7/kg, and ABO blood type identical to the recipient. Following intravenous infusion, it promotes platelet recovery by providing hematopoietic stem cells, mesenchymal stem cells, endothelial progenitor cells, and growth factors that stimulate bone marrow progenitor cell proliferation in the in vivo environment, thereby elevating platelet levels. The primary endpoint of this study is: Treatment efficacy rate: Post-treatment platelet count ≥100×10\^9/L, or an increase of ≥50×10\^9/L from baseline, or an increase of ≥100% from baseline. Secondary endpoints include: Platelet first response time: Time to first platelet count ≥100×10\^9/L without platelet transfusion; Maximum and minimum platelet counts; Incidence of bleeding events after initial infusion; Number of platelet transfusions; Changes in thrombocytopenia grading; Treatment-related adverse events; Incidence and grading of graft-versus-host disease (GVHD).

Conditions

• Thrombocytopenia
• Cancer Treatment-induced Thrombocytopenia

Interventions

Type	Name	Description
OTHER	umbilical cord blood	Umbilical cord blood will be selected from a public cord blood bank, requiring an HLA match of 0-3/10, a total nucleated cell (TNC) count \>1 × 10⁷/kg, and ABO blood type identical to the recipient. The umbilical cord blood will be intravenously infused into the subject within 30 minutes.

Timeline

• Start date: 2026-02-28
• Primary completion: 2027-06-30
• Completion: 2027-12-30
• First posted: 2026-03-02
• Last updated: 2026-03-02

Locations

1 site across 1 country: China