Actively Recruiting
The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Patients With Secondary Poor Graft Function After Hematopoietic Stem Cell Transplantation
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-03-13
15
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is conducted in a prospective, single-center clinical design and is divided into two stages: dose escalation and dose extension. Patients meeting the diagnostic criteria of secondary poor graft function are selected as the study objects. The safety data of umbilical cord blood mononuclear cells in the treatment of secondary poor graft function are obtained through dose escalation stage, and then one dose is selected for dose extension stage to explore the efficacy of umbilical cord blood mononuclear cells in treating secondary poor graft function.
CONDITIONS
Official Title
The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Patients With Secondary Poor Graft Function After Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with secondary poor graft function after hematopoietic stem cell transplantation, defined as cytopenia lasting more than 2 weeks after initial hematopoietic recovery
- Eastern Cooperative Oncology Group (ECOG) physical status score of 2 or less
- Signed informed consent to participate in the study
You will not qualify if you...
- Serious uncontrolled infection
- Active bleeding
- Cardiac insufficiency with ejection fraction less than 50% or serious heart disease including myocardial infarction
- Liver or kidney dysfunction defined as total bilirubin over 35 �b5mol/L, ALT or AST more than twice the upper normal limit, or serum creatinine over 130 �b5mol/L
- Pregnant or breastfeeding women
- Presence of malignant tumors in other organs
- Inability to understand or comply with the study protocol
- Participation in other clinical trials
- Any other condition deemed inappropriate by the investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital, China
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
E
erlie EL Jiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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