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

NCT07201233 | Not Yet Recruiting

• 1 other identifier: UCB-2025
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Bone Marrow Suppression

Outcome Measures

Primary Outcomes (5)

• Percentage of patients with bone marrow suppression grade < II.

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

  Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.

• hematological parameters like hemoglobin level(Hb)

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

  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)

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

  Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.

• hematological parameters like platelet count(PLT)

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

  Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.

• hematological parameters like neutrophil count(ANC)

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

  Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.

Secondary Outcomes (2)

• Incidence of bleeding

  Up to 30 days after umbilical cord blood treatment

• Incidence of infection

  Up to 30 days after umbilical cord blood treatment.

Study Arms (1)

Umbilical cord blood

EXPERIMENTAL

Biological: Umbilical cord blood

Interventions

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.

Umbilical cord blood

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Ages 60-80 years , gender unlimited;
• \) Patients clinically diagnosed with MDS or AML;
• \) Completed chemotherapy and clinically diagnosed with bone marrow suppression grade 2 or above;
• \) 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);
• \) Normal cardiac function;
• \) Patients with ECOG 0-2;
• \) Patients or their families have been informed and voluntarily signed a written informed consent form.

You may not qualify if:

• \) Other factors that may cause abnormalities in white blood cells and neutrophils, such as concurrent infections, invasive procedures, etc.
• )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.
• \) Any other uncontrolled active diseases that may interfere with participation in the trial;
• \) Concurrent diagnosis of malignant tumors in other organs;
• \) Concurrent diagnosis of other hematological disorders;
• \) Inability to understand or comply with the study protocol;
• \) Individuals deemed unsuitable for participation in this trial by the investigator.

Sponsors & Collaborators

• Shandong Qilu Stem Cells Engineering Co., Ltd.: lead
• Tianjin Medical University General Hospital: collaborator

Central Study Contacts

Huaquan Wang

CONTACT

13920745277; wanghuaquan@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: October 1, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share