Pediatric CancerNCT07866534
Umbilical Cord Blood Infusion to Promote Hematopoietic and Immune Reconstitution in Children With Relapsed or Refractory Malignant Solid Tumors
A study testing umbilical cord blood in people with Pediatric Cancer and Solid Tumor Cancer, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Pediatric Cancer, Solid Tumor Cancer
- What is being tested?
- umbilical cord blood
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 1-18 years, any sex;
- Histopathologically confirmed pediatric malignant solid tumor (including but not limited to neuroblastoma, Wilms tumor, hepatoblastoma, rhabdomyosarcoma, osteosarcoma, Ewing sarcoma, and germ cell tumors), assessed by the investigator as high-risk, relapsed, or refractory;
- In relapsed or refractory status requiring salvage chemotherapy;
- Severe myelosuppression after the most recent chemotherapy cycle, meeting at least one of the following: ANC <0.5×10^9/L or platelet count <20×10^9/L; AND persistent ANC <1.0×10^9/L and platelets <50×10^9/L despite ≥7 days of standard supportive care (short-acting rhG-CSF 5 μg/kg/day and rhTPO 300 U/kg/day), resulting in a delay of ≥3 days of the next chemotherapy cycle;
- During the chemotherapy delay period, platelet count ≥20×10^9/L (transfusion permitted) and hemoglobin ≥60 g/L (transfusion permitted) after standard supportive care;
- Adequate major organ function: liver function (ALT/AST ≤2.5× ULN, total bilirubin ≤1.5× ULN); renal function (creatinine clearance ≥60 mL/min/1.73 m²); cardiac function (echocardiographic shortening fraction ≥28%);
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- ECOG performance status ≤2 (or Lansky play-performance score ≥50%);
- Expected survival ≥12 weeks;
- The guardian fully understands the study and voluntarily signs the informed consent form, agreeing to the patient's completion of immune function monitoring (peripheral blood lymphocyte subsets, NK cells, and serum cytokines); age-appropriate assent is obtained from the child (oral assent with an illustrated assent form for ages 8-12 years; written assent with an adolescent assent form for ages 12-18 years);
- For repeat infusions: the patient remains in relapsed/refractory status requiring continued chemotherapy and again meets the myelosuppression criterion in item 4.
Who cannot join
- Progressive disease (PD) with investigator judgment that the patient is not suitable for continued chemotherapy;
- Concurrent second primary malignancy or prior history of other malignancies;
- Any active autoimmune disease or history of autoimmune disease;
- Current use of immunosuppressants, or systemic glucocorticoid therapy for immunosuppressive purposes (physiologic replacement therapy excepted), continued within 2 weeks before enrollment;
- Known allergy to umbilical cord blood components or history of severe transfusion-related adverse reactions;
- Active, uncontrolled infection requiring intravenous anti-infective therapy for more than 72 hours without control;
- Known history of psychotropic drug abuse;
- Any other condition judged by the investigator that could lead to forced early termination of the study, such as other serious diseases (including psychiatric disorders) requiring concomitant treatment, severe laboratory abnormalities, or family/social factors affecting the safety of the participant or the integrity of study data.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Exploratory Study of Umbilical Cord Blood Infusion to Promote Hematopoietic and Immune System Reconstitution in Pediatric Patients With Relapsed or Refractory Malignant Solid Tumors
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.
Read more
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.
- Conditions
- Pediatric Cancer, Solid Tumor Cancer
- Being tested
- umbilical cord blood
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord bloodOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical Cord Blood Infusion | Experimental | Not described Receives: Other: umbilical cord blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 21 days after each UCB infusion (up to 12 weeks from first infusion)
Secondary outcomes (9)
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.
Measured: 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.
Measured: Baseline, Day 14, and Day 28 after each infusion
Serum Cytokine Levels
Measured: 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.
Measured: 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.
Measured: 2 weeks after each infusion
Infection Incidence
Measured: 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]).
Measured: 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)
Measured: From first infusion through 12 weeks of follow-up
Use of Hematopoietic Growth Factors (rhG-CSF/rhTPO)
Measured: Up to 12 weeks from first infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Hematology & Blood Diseases Hospital, China, Union Stem Cell & Gene Engineering Co
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866534
- Sponsor's protocol ID
- E20261132
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Umbilical Cord Blood Infusion to Promote Hematopoietic and Immune System Reconstitution in Pediatric Patients With Relapsed or Refractory Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07866534
- Acronym / sponsor ID
- E20261132
- Conditions
- Pediatric Cancer, Solid Tumor Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Institute of Hematology & Blood Diseases Hospital, China, Union Stem Cell & Gene Engineering Co
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Blood Infusion | Experimental | Other: umbilical cord blood |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Age 1-18 years, any sex;
- Histopathologically confirmed pediatric malignant solid tumor (including but not limited to neuroblastoma, Wilms tumor, hepatoblastoma, rhabdomyosarcoma, osteosarcoma, Ewing sarcoma, and germ cell tumors), assessed by the investigator as high-risk, relapsed, or refractory;
- In relapsed or refractory status requiring salvage chemotherapy;
- Severe myelosuppression after the most recent chemotherapy cycle, meeting at least one of the following: ANC <0.5×10^9/L or platelet count <20×10^9/L; AND persistent ANC <1.0×10^9/L and platelets <50×10^9/L despite ≥7 days of standard supportive care (short-acting rhG-CSF 5 μg/kg/day and rhTPO 300 U/kg/day), resulting in a delay of ≥3 days of the next chemotherapy cycle;
- During the chemotherapy delay period, platelet count ≥20×10^9/L (transfusion permitted) and hemoglobin ≥60 g/L (transfusion permitted) after standard supportive care;
Key exclusion criteria (8 listed)
- Progressive disease (PD) with investigator judgment that the patient is not suitable for continued chemotherapy;
- Concurrent second primary malignancy or prior history of other malignancies;
- Any active autoimmune disease or history of autoimmune disease;
- Current use of immunosuppressants, or systemic glucocorticoid therapy for immunosuppressive purposes (physiologic replacement therapy excepted), continued within 2 weeks before enrollment;
- Known allergy to umbilical cord blood components or history of severe transfusion-related adverse reactions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| umbilical cord bloodCryopreserved 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. | Other | Umbilical Cord Blood Infusion |
Primary outcome
Composite Primary Endpoint Achievement Rate
Time frame: Within 21 days after each UCB infusion (up to 12 weeks from first infusion)
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%).
On-schedule Chemotherapy Completion Rate
Time frame: From each UCB infusion to the next scheduled chemotherapy cycle (up to 12 weeks from first infusion)
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 to ANC Recovery
Time frame: Up to 21 days after each UCB infusion (up to 12 weeks from first infusion)
Number of days from each UCB infusion to ANC ≥1.0×10^9/L sustained for ≥3 days.
Time to Platelet Recovery
Time frame: Up to 21 days after each UCB infusion (up to 12 weeks from first infusion)
Number of days from each UCB infusion to platelet count ≥50×10^9/L with platelet-transfusion independence for ≥7 days.
9 secondary outcomes
Number of participants with Grade ≥3 hematologic laboratory abnormalities, assessed by NCI-CTCAE v5.0
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
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
Time frame: 2 weeks after each infusion
Number of platelet concentrate transfusions after cord blood infusion
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing umbilical cord blood in people with Pediatric Cancer and Solid Tumor Cancer, run by Tianjin Medical University Cancer Institute and Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Jin (+8613212163398, jinyan0713@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Primary Endpoint Achievement Rate (time frame: Within 21 days after each UCB infusion (up to 12 weeks from first infusion)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.