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

Shandong Qilu Stem Cells Engineering

Status

Not yet enrolling

Conditions

Bone Marrow Suppression

Treatments

Biological: Umbilical cord blood

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07201233

UCB-2025

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

60 to 80 years old

Volunteers

No Healthy Volunteers

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.