An interventional study of umbilical cord blood in Pediatric Cancer and Solid Tumor Cancer, sponsored by Tianjin Medical University Cancer Institute and Hospital. Not yet recruiting. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Not applicable, Interventional, and Treatment
Pediatric malignant solid tumors (including neuroblastoma, Wilms tumor, hepatoblastoma, rhabdomyosarcoma, osteosarcoma, Ewing sarcoma, and germ cell tumors) account for approximately 60% of childhood malignancies. Despite multimodal therapy, children with relapsed or refractory disease have poor outcomes. Repeated lines of intensive salvage chemotherapy cause cumulative damage to the hematopoietic system, resulting in profound and prolonged myelosuppression (absolute neutrophil count \<0.5×10\^9/L or platelet count \<20×10\^9/L) that often fails to recover despite standard supportive care with short-acting recombinant human granulocyte colony-stimulating factor (rhG-CSF) and recombinant human thrombopoietin (rhTPO). This leads to chemotherapy delays that compromise treatment continuity and intensity.
Umbilical cord blood (UCB) contains hematopoietic progenitor cells, NK cells, T lymphocytes, and various hematopoietic and immunomodulatory factors. UCB infusion has been shown to accelerate hematopoietic recovery after chemotherapy and may enhance anti-tumor immune function.
This is a single-center, single-arm, prospective exploratory study. Approximately 10 children (aged 1-18 years) with relapsed or refractory malignant solid tumors who develop severe post-chemotherapy myelosuppression with delayed hematopoietic recovery (persistent ANC \<1.0×10\^9/L and platelets \<50×10\^9/L despite ≥7 days of rhG-CSF/rhTPO support, resulting in chemotherapy delay) will receive UCB infusion in addition to continuing background anti-tumor therapy and standardized hematopoietic supportive care. Each patient may receive up to 3 UCB infusions. The follow-up period is 12 weeks from the first infusion.
The study aims to: (1) evaluate the effect of UCB infusion on promoting hematopoietic recovery and on-schedule chemotherapy completion (compared with institutional historical controls); (2) evaluate immune reconstitution after UCB infusion, including dynamics of T-lymphocyte subsets, NK cells, B cells, and serum cytokines; (3) assess the safety of UCB infusion; and (4) explore differences in hematopoietic recovery and immune reconstitution across tumor types and treatment backgrounds.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's planned enrollment of 10 is below the median of 50 across 7,429 interventional studies indexed under Neoplasms.
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Exclusion Criteria:
Other: umbilical cord blood
Cryopreserved umbilical cord blood unit(s) selected by Tianjin Cord Blood Hematopoietic Stem Cell Bank (HLA-A, -B, -C, -DRB1, -DQB1 ≤5/10 match acceptable; ABO and Rh(D) compatible; TNC ≥1.5×10\^7/kg body weight). The unit is thawed in a 37-40°C water bath and infused intravenously over approximately 30 minutes with premedication (diphenhydramine and acetaminophen; dexamethasone if indicated) and continuous vital-sign monitoring. Each patient may receive up to 3 infusions, with an interval of ≥21 days between infusions.
Composite Primary Endpoint Achievement Rate
Proportion of UCB infusions for which all three of the following criteria are met: (1) on-schedule completion of the next chemotherapy cycle (delay ≤3 days); (2) ANC recovery to ≥1.0×10\^9/L sustained for ≥3 days within 21 days after infusion; (3) platelet recovery to ≥50×10\^9/L with platelet-transfusion independence for ≥7 days within 21 days after infusion. Each infusion is evaluated as an independent event, and the best response per patient is recorded. Results are described in comparison with institutional historical controls (on-schedule chemotherapy completion rate approximately 30%-40%).
Time frame: Within 21 days after each UCB infusion (up to 12 weeks from first infusion)
On-schedule Chemotherapy Completion Rate
Proportion of UCB infusions after which the patient successfully receives the next chemotherapy cycle on the scheduled date (per the background regimen); the actual interval (days) from UCB infusion to the next chemotherapy cycle is recorded.
Time frame: From each UCB infusion to the next scheduled chemotherapy cycle (up to 12 weeks from first infusion)
Time to ANC Recovery
Number of days from each UCB infusion to ANC ≥1.0×10\^9/L sustained for ≥3 days.
Time frame: Up to 21 days after each UCB infusion (up to 12 weeks from first infusion)
Time to Platelet Recovery
Number of days from each UCB infusion to platelet count ≥50×10\^9/L with platelet-transfusion independence for ≥7 days.
Time frame: Up to 21 days after each UCB infusion (up to 12 weeks from first infusion)
Number of participants with Grade ≥3 hematologic laboratory abnormalities, assessed by NCI-CTCAE v5.0
WBC, ANC, hemoglobin, and platelet results collected at baseline and on Days 1, 3, 5, 7, 10, and 14 after each infusion will be graded according to NCI-CTCAE v5.0. The number and percentage of participants with Grade ≥3 hematologic laboratory abnormalities will be reported.
Time frame: Baseline and Days 1, 3, 5, 7, 10, 14 after each infusion
Absolute counts and percentages of lymphocyte subsets (CD3+, CD4+, CD8+ T cells, CD16+CD56+ NK cells, CD19+ B cells, and CD4+CD25+FoxP3+ regulatory T cells), measured by multiparameter flow cytometry
Peripheral blood will be collected at baseline (before each cord blood infusion) and on Days 14 and 28 after each infusion. Lymphocyte subsets will be identified and quantified by multiparameter flow cytometry, including CD3+, CD4+, and CD8+ T cells (with the CD4+/CD8+ ratio), NK cells (CD16+CD56+), B cells (CD19+), and regulatory T cells (CD4+CD25+FoxP3+). Each subset will be reported separately: absolute counts (cells/µL) and percentages among lymphocytes (%) will be summarized at each time point using descriptive statistics (mean ± SD or median \[IQR\]), and changes from baseline will be compared by paired t-test or Wilcoxon signed-rank test.
Time frame: Baseline, Day 14, and Day 28 after each infusion
Serum Cytokine Levels
Time frame: Baseline, Day 14, and Day 28 after each infusion
Number of units of red blood cells transfused after cord blood infusion
Red blood cell transfusion records will be reviewed within 2 weeks after each cord blood infusion. The volume of red blood cell transfusion (in units) will be recorded for each infusion and summarized per participant using descriptive statistics (mean ± SD or median \[IQR\]). Post-infusion transfusion requirements will be compared with the participant's own pre-infusion/historical data using Wilcoxon signed-rank test.
Time frame: 2 weeks after each infusion
Number of platelet concentrate transfusions after cord blood infusion
Platelet transfusion records will be reviewed within 2 weeks after each cord blood infusion. The number of platelet concentrate transfusions (in bags) will be recorded for each infusion and summarized per participant using descriptive statistics (mean ± SD or median \[IQR\]). Post-infusion transfusion requirements will be compared with the participant's own pre-infusion/historical data using Wilcoxon signed-rank test.
Time frame: 2 weeks after each infusion
Infection Incidence
Time frame: 2 weeks after each infusion
Percentage of donor chimerism, assessed by short tandem repeat (STR) analysis
Peripheral blood will be collected on Day 14 after each cord blood infusion, and donor chimerism will be quantified by short tandem repeat (STR) analysis against the pre-infusion recipient baseline STR profile and the cord blood donor reference profile. The percentage of donor-derived cells will be reported for each infusion. If donor chimerism exceeds 5%, chimerism testing will be repeated on Days 28 and 56 after that infusion. Results will be summarized per participant using descriptive statistics (median \[range\]).
Time frame: Day 14 after each infusion (plus Days 28 and 56 if chimerism >5%)
Incidence and Severity of Adverse Events (Cumulative Safety of Up to 3 Infusions)
Time frame: From first infusion through 12 weeks of follow-up
Use of Hematopoietic Growth Factors (rhG-CSF/rhTPO)
Time frame: Up to 12 weeks from first infusion
Time to lymphocyte recovery (ALC ≥1.0×10⁹/L), NK cell recovery (≥100 cells/µL), and CD4+ T cell recovery (≥200 cells/µL), measured by automated hematology analyzer and multiparameter flow cytometry
Within 12 weeks from the first cord blood infusion, the time to recovery will be assessed for three parameters, each reported separately in days as median (range): (1) time to absolute lymphocyte count (ALC) recovery, defined as ALC ≥1.0×10⁹/L, measured by automated hematology analyzer; (2) time to NK cell recovery, defined as absolute NK cell count (CD16+CD56+) ≥100 cells/µL, measured by multiparameter flow cytometry; (3) time to CD4+ T cell recovery, defined as absolute CD4+ T cell count ≥200 cells/µL, measured by multiparameter flow cytometry. As an exploratory analysis, the correlation between each time-to-recovery endpoint and hematologic recovery time (ANC and platelet recovery time) will be evaluated by Spearman correlation analysis.
Time frame: Up to 12 weeks from first infusion
Time to ANC recovery, compared between neuroblastoma and other pediatric solid tumor subgroups
Participants will be stratified by tumor type (neuroblastoma versus other pediatric malignant solid tumors). Time from first cord blood infusion to ANC recovery (days) will be summarized within each stratum as median \[range\] and compared between strata by Mann-Whitney U test. This comparison is exploratory; no additional measurements are collected for this analysis.
Time frame: Up to 12 weeks from first infusion
Time to platelet recovery, compared between neuroblastoma and other pediatric solid tumor subgroups
Participants will be stratified by tumor type (neuroblastoma versus other pediatric malignant solid tumors). Time from first cord blood infusion to platelet recovery time (days) will be summarized within each stratum as median \[range\] and compared between strata by Mann-Whitney U test. This comparison is exploratory; no additional measurements are collected for this analysis.
Time frame: Up to 12 weeks from first infusion
Lymphocyte subset counts, compared between neuroblastoma and other pediatric solid tumor subgroups
Participants will be stratified by tumor type... Absolute counts of lymphocyte subsets (cells/μL) will be summarized within each stratum as mean ± SD or median \[IQR\] and compared between strata by Mann-Whitney U test. This comparison is exploratory; no additional measurements are collected for this analysis.
Time frame: Up to 12 weeks from first infusion
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data may be made available upon reasonable request to the principal investigator after publication of the study results, subject to approval by the Ethics Committee of Tianjin Medical University Cancer Institute and Hospital.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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