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NCT Number: NCT07201233

Clinical Study on the Safety and Efficacy of Umbilical Cord Blood Infusion in Treating Bone Marrow Suppression .

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

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

umbilical cord blood

Biological

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 outcomes

  1. 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.

    Calculate the percentage of patients with bone marrow suppression grade < II based on recorded hematological parameters.

  2. 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.

    Monitor and record hemoglobin level(g/L), every 2 days in patients, and maintain a record.

  3. 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.

    Monitor and record white blood cell count( 10⁹/L)every 2 days in patients, and maintain a record.

  4. 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.

    Monitor and record platelet count ( 10⁹/L)every 2 days in patients, and maintain a record.

  5. 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.

    Monitor and record neutrophil count ( 10⁹/L)every 2 days in patients, and maintain a record.

Secondary outcomes

  1. Incidence of bleeding

    Time frame: Up to 30 days after umbilical cord blood treatment

    To investigate the efficacy characteristics, percentages will be calculated.

  2. Incidence of infection

    Time frame: Up to 30 days after umbilical cord blood treatment.

    To investigate the efficacy characteristics, percentages will be calculated.

Study contacts

Contact information is provided by the study sponsor or research team.

Huaquan Wang

CONTACT

[email protected]

13920745277

Sponsors and collaborators

Lead sponsor

Shandong Qilu Stem Cells Engineering Co., Ltd.

Industry

Collaborators

  • Tianjin Medical University General Hospital

Registry information

Official study 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) .

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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