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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbilical Cord Blood for CTIT Treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment efficacy rate | 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. | 28 days post-infusion |
| Treatment-related adverse events | 28 days post-infusion |
| Measure | Description | Time Frame |
|---|---|---|
| (1)Platelet first response time and maximum and minimum platelet counts; | Platelet first response time: Time to first platelet count ≥100×10^9/L without platelet transfusion and maximum and minimum platelet counts; | 28days post-infusion |
| Incidence of bleeding events after initial infusion; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaolin Yuan | Contact | +86 057188122153 | yuanxiaolinhaha@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology, Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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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.
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| 28 days post-infusion |
| Number of platelet transfusions; | 28 days post-infusion |
| Changes in thrombocytopenia grading; | 28 days post-infusion |
| Incidence and grading of graft-versus-host disease (GVHD) | 100 days post-infusion |