Status:
NOT_YET_RECRUITING
Clinical Study on the Safety and Efficacy of Umbilical Cord Blood Infusion in Treating Bone Marrow Suppression .
Lead Sponsor:
Shandong Qilu Stem Cells Engineering Co., Ltd.
Collaborating Sponsors:
Tianjin Medical University General Hospital
Conditions:
Bone Marrow Suppression
Eligibility:
All Genders
60-80 years
Phase:
NA
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 eld...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07201233
Start Date
November 1 2025
End Date
December 31 2027
Last Update
October 1 2025
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