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

NCT ID: NCT07201233

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-12-31

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

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.

Conditions

Bone Marrow Suppression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Umbilical cord blood

Group Type: EXPERIMENTAL

Umbilical cord blood

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University General Hospital

OTHER

Sponsor Role: collaborator

Shandong Qilu Stem Cells Engineering Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Huaquan Wang

Role: CONTACT

wanghuaquan@tmu.edu.cn

13920745277

Other Identifiers

UCB-2025

Identifier Type: -

Identifier Source: org_study_id