Clinical trial · Interventional
Safety and Efficacy of Umbilical Cord Blood Therapy for Cancer Therapy-Induced Thrombocytopenia (CTIT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Treatment-induced Thrombocytopenia | — | UNRESOLVED | — |
| Thrombocytopenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| umbilical cord blood | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Umbilical Cord Blood for CTIT Treatment
- description
- 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.
- interventionNames
- Other: umbilical cord blood
Primary outcomes (2)
- measure
- Treatment efficacy rate
- timeFrame
- 28 days post-infusion
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 12 to 65 years at the time of signing the informed consent, regardless of gender. 2. Meets the diagnostic criteria for cancer treatment-induced thrombocytopenia (CTIT):Peripheral blood platelet count \< 100 × 10⁹/L; Prior definite exposure to a chemotherapy agent (or tumor-targeted therapy, immunotherapy, or other anti-tumor drugs) known to cause thrombocytopenia, with gradual improvement of thrombocytopenia-related symptoms/signs or normalization of platelet count after discontinuation of the offending drug; Presence or absence of bleeding tendency, such as petechiae, purpura, unexplained epistaxis, or even severe organ/tissue hemorrhage; 3. No significant hepatic or renal impairment: ALT and AST ≤ 2.5 × upper limit of normal (ULN), serum creatinine (Cr) and blood urea nitrogen (BUN) ≤ 1.25 × ULN; 4. Karnofsky Performance Status (KPS) score ≥ 60 (see Appendix 1), Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix 2); 5. Estimated life expectancy of more than 3 months. Exclusion Criteria: 1. Other causes of thrombocytopenia, in particular exclusion of underlying diseases or comorbidities such as aplastic anemia, acute leukemia, radiation sickness, immune thrombocytopenia (ITP), hypersplenism, or bone marrow infiltration by tumor cells; 2. Use of non-anti-tumor medications known to cause thrombocytopenia (including but not limited to sulfonamides and other drugs); 3. Pseudothrombocytopenia induced by ethylenediaminetetraacetic acid (EDTA) anticoagulant; 4. Uncontrolled malignant tumor, hypertension, or diabetes mellitus; 5. Active infection, including but not limited to known HIV positivity, active hepatitis B or C, or syphilis; 6. Poor compliance; 7. Known allergy or hypersensitivity to any component of the study intervention (umbilical cord blood or related products); 8. Participation in another clinical trial within 1 month prior to enrollment or current participation in another clinical trial; 9. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this clinical study.
References
Publications (0)
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