A Randomized Controlled, Open, Single-center Clinical Study Evaluating the Efficacy and Safety of Umbilical Cord Blood Mononuclear Cells in Patients with Refractory Immune Effector Cell-related Hemocytopenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Umbilical cord blood mononuclear cells, Conventional hematopoietic recovery therapy.
- Who it may be relevant to
- Registry conditions: Refractory Immune Effector Cell-related Hemocytopenia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this study was to evaluate the safety and efficacy of umbilical cord blood mononuclear cell in the treatment of refractory immune effector cell-related hemocytopenia by observing the efficacy related factors and adverse reactions.
Interventions
- Biological Umbilical cord blood mononuclear cells
Intravenous infusion of UCB-MNCs (3×10\^8/ time, once a week, four times in total) - Combination product Conventional hematopoietic recovery therapy
Including but not limited to G-CSF, TPO, TPO receptor agonists, transfusions of red blood cells, platelets, etc.
Primary outcome measures
- The recovery time of neutrophils [Time frame: 1 year]
- The recovery time of platelet [Time frame: 1 year]
- Safety of infusion [Time frame: 1 year]
Secondary outcome measures (3)
- Recovery of hemoglobin levels after infusion [Time frame: 1 year]
- Immune function reconstruction indicators at 1, 3, 6, and 12 months after transfusion [Time frame: 1, 3, 6, and 12 months]
- Overall survival rate [Time frame: 2 and 5 year]
Eligibility criteria
Inclusion criteria
- Age ≥18 years old (including boundary values), gender is not limited
- ECOG score 0-2 points
- Expected survival ≥6 months
- Patients who have received immune effector cell therapy (marketed CAR-T cell therapy or dual antibody therapy) (no target), have grade 3-4 hemocytopenia after treatment, and do not recover to grade 2 within 3 weeks after conventional treatment. Defined as follows:
1\) The neutrophils again decreased to grade ≥3 within 1 week after G-CSF discontinuation, or 2) Unable to detach from red blood cell or platelet transfusion (infusion time less than one week requires re-infusion) (5) Understand the research protocol and sign the informed consent voluntarily
Exclusion criteria
- Patients who intend to undergo autologous hematopoietic stem cell transfusion or have undergone autologous hematopoietic stem cell transfusion
- Significant lack of compliance to complete the study plan (such as suffering from uncontrolled mental illness, etc.)
- Allergy or known allergy to any drug active ingredients, excipients, and blood products or preparations included in this study
- Pregnancy, breastfeeding, planning pregnancy, or unwillingness to use effective contraception as required by research
- There are other conditions that researchers believe are not suitable for inclusion
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing GoBroad Hospital — Beijing
Identifiers
NCT: NCT06729320 · UCB-MNCs-2024