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Tests treatment safety and results for Poor Graft Function
Official title The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Patients With Secondary Poor Graft Function After Hematopoietic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT06792682
What this study is testing
What is Dose escalation?
Dose escalation is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for poor graft function.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age≥18 years old; gender is not limited.
- Meet the diagnostic criteria for secondary poor graft function: After 28 days of transplantation, patients who had achieved hematopoietic...
- Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 2 points.
- people sign informed consent.
You likely can't join if
- Serious infection not controlled.
- Active bleeding.
- Patients with cardiac insufficiency (ejection fraction\<50%), or suffering from serious heart disease, including myocardial infarction, cardiac...
- Patients with hepatic and renal insufficiency (total bilirubin\>35µmol/L, ALT and AST\>2 times of the upper limit of normal; serum...
- Pregnant or lactating women.
- Concurrent malignant tumors of other organs.
See the full eligibility criteria
- Age≥18 years old; gender is not limited.
- Meet the diagnostic criteria for secondary poor graft function: After 28 days of transplantation, patients who had achieved hematopoietic reestablishment (ANC ≥ 0.5×10\^9/L for 3 consecutive days without G-CSF...
- Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 2 points.
- people sign informed consent.
- Serious infection not controlled.
- Active bleeding.
- Patients with cardiac insufficiency (ejection fraction\<50%), or suffering from serious heart disease, including myocardial infarction, cardiac insufficiency, etc.
- Patients with hepatic and renal insufficiency (total bilirubin\>35µmol/L, ALT and AST\>2 times of the upper limit of normal; serum creatinine\>130µmol/L).
- Pregnant or lactating women.
- Concurrent malignant tumors of other organs.
- Failure to understand or follow the research protocol.
- Patients participating in other clinical investigations.
- Other conditions that the investigators consider inappropriate to participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.