Clinical Study on the Safety and Efficacy of Umbilical Cord Blood Infusion in Treating Bone Marrow Suppression .
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Umbilical cord blood.
- Who it may be relevant to
- Registry conditions: Bone Marrow Suppression. Basic parameters: 60 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Study on the Safety and Efficacy of Unrelated Umbilical Cord Blood Infusion in Treating Bone Marrow Suppression After Chemotherapy in Elderly Patients With Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) .
Overview
The clinical study aims to evaluate the safety and efficacy of umbilical cord blood transfusion in treating bone marrow suppression after chemotherapy in elderly patients with MDS and AML
Detailed description
The clinical study aims to evaluate the safety and efficacy of umbilical cord blood （HLA typing 0-3/10 match, TNC ≥ 3×10\^7/kg）transfusion in treating bone marrow suppression after chemotherapy in elderly patients with MDS and AML，UCB can be applied in one to multiple doses, and the minimum interval between two cord blood transfusions should be 2 weeks.
Interventions
- Biological Umbilical cord blood
Umbilical cord blood transfusion should be performed 24 hours to 2 weeks after chemotherapy. One to multiple units of cord blood can be applied, and the minimum interval between two cord blood transfusions should be 2 weeks.
Primary outcome measures
- Percentage of patients with bone marrow suppression grade < II. [Time frame: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.]
- hematological parameters like hemoglobin level(Hb) [Time frame: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.]
- hematological parameters like white blood cell count(WBC) [Time frame: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.]
- hematological parameters like platelet count(PLT) [Time frame: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.]
- hematological parameters like neutrophil count(ANC) [Time frame: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.]
Secondary outcome measures (2)
- Incidence of bleeding [Time frame: Up to 30 days after umbilical cord blood treatment]
- Incidence of infection [Time frame: Up to 30 days after umbilical cord blood treatment.]
Eligibility criteria
Inclusion criteria
- 1\) Ages 60-80 years , gender unlimited;
- 2\) Patients clinically diagnosed with MDS or AML;
- 3\) Completed chemotherapy and clinically diagnosed with bone marrow suppression grade 2 or above;
- 4\) Patients with no severe impairment of liver and kidney function (total bilirubin (TBIL): ≤ 1.5×ULN; ALT or AST: ≤ 2.5×ULN; Alkaline phosphatase: ≤ 3×ULN; Serum creatinine: ≤ 1.5×ULN);
- 5\) Normal cardiac function;
- 6\) Patients with ECOG 0-2;
- 7\) Patients or their families have been informed and voluntarily signed a written informed consent form.
Exclusion criteria
- 1\) Other factors that may cause abnormalities in white blood cells and neutrophils, such as concurrent infections, invasive procedures, etc.
- 2)Presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (such as diabetes, hypertension, pulmonary fibrosis, and acute pneumonia, etc.). Any unstable systemic diseases: including but not limited to unstable angina, cerebrovascular accident or transient ischemic attack (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association NYHA classification ≥ III,), severe arrhythmias requiring medication, liver, kidney, or metabolic diseases.
- 3\) Any other uncontrolled active diseases that may interfere with participation in the trial;
- 4\) Concurrent diagnosis of malignant tumors in other organs;
- 5\) Concurrent diagnosis of other hematological disorders;
- 6\) Inability to understand or comply with the study protocol;
- 7\) Individuals deemed unsuitable for participation in this trial by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07201233 · UCB-2025