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

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT07441720
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • umbilical cord blood — OTHER
    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.

Study Details

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.

Key Dates

Start date
Feb 28, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Umbilical Cord Blood for CTIT Treatment
    Participants receive intravenous infusion of allogeneic umbilical cord blood (HLA matching 0-3/10 loci, total nucleated cells \[TNC\] \>1×10\^7/kg, ABO blood type identical/compatible). Infusions are administered 2-4 times as needed based on clinical response. Platelet transfusions are permitted as supportive therapy if required. The intervention aims to promote platelet recovery through hematopoietic stem cells, mesenchymal stem cells, endothelial progenitor cells, and associated growth factors in patients with cancer treatment-induced thrombocytopenia (CTIT). No comparator or control arm is included in this single-arm design.

Primary Outcome Measure

Treatment efficacy rate [ Time Frame: 28 days post-infusion ]

Central Contacts

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