Bone Marrow SuppressionNCT07201233
Clinical Study on the Safety and Efficacy of Umbilical Cord Blood Infusion in Treating Bone Marrow Suppression .
A study testing Umbilical cord blood in people with Bone Marrow Suppression, run by Shandong Qilu Stem Cells Engineering Co., Ltd..
Trial 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 Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Bone Marrow Suppression
- What is being tested?
- Umbilical cord blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Study on the Safety and Efficacy of Unrelated Umbilical Cord Blood Infusion in Treating Bone Marrow Suppression After Chemotherapy in Elderly Patients With Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) .
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
Read the 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 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.
- Conditions
- Bone Marrow Suppression
- Being tested
- Umbilical cord blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord bloodBiological
Umbilical cord blood transfusion should be performed 24 hours to 2 weeks after chemotherapy. One to multiple units of cord blood can be applied, and the minimum interval between two cord blood transfusions should be 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical cord blood | Experimental | Not described Receives: Biological: Umbilical cord blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with bone marrow suppression grade < II.
Calculate the percentage of patients with bone marrow suppression grade < II based on recorded hematological parameters.
Measured: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.
hematological parameters like hemoglobin level(Hb)
Monitor and record hemoglobin level(g/L), every 2 days in patients, and maintain a record.
Measured: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.
hematological parameters like white blood cell count(WBC)
Monitor and record white blood cell count( 10⁹/L)every 2 days in patients, and maintain a record.
Measured: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.
hematological parameters like platelet count(PLT)
Monitor and record platelet count ( 10⁹/L)every 2 days in patients, and maintain a record.
Measured: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.
hematological parameters like neutrophil count(ANC)
Monitor and record neutrophil count ( 10⁹/L)every 2 days in patients, and maintain a record.
Measured: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.
Secondary outcomes (2)
Incidence of bleeding
To investigate the efficacy characteristics, percentages will be calculated.
Measured: Up to 30 days after umbilical cord blood treatment
Incidence of infection
To investigate the efficacy characteristics, percentages will be calculated.
Measured: Up to 30 days after umbilical cord blood treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow SuppressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Qilu Stem Cells Engineering Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tianjin Medical University General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201233
- Sponsor's protocol ID
- UCB-2025
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of Unrelated Umbilical Cord Blood Infusion in Treating Bone Marrow Suppression After Chemotherapy in Elderly Patients With Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) .
- ClinicalTrials.gov ID
- NCT07201233
- Acronym / sponsor ID
- UCB-2025
- Conditions
- Bone Marrow Suppression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shandong Qilu Stem Cells Engineering Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Tianjin Medical University General Hospital
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Umbilical cord blood | Experimental | Biological: Umbilical cord blood |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical cord bloodUmbilical cord blood transfusion should be performed 24 hours to 2 weeks after chemotherapy. One to multiple units of cord blood can be applied, and the minimum interval between two cord blood transfusions should be 2 weeks. | Biological | Umbilical cord blood |
Primary outcome
Percentage of patients with bone marrow suppression grade < II.
Time frame: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.
Calculate the percentage of patients with bone marrow suppression grade < II based on recorded hematological parameters.
hematological parameters like hemoglobin level(Hb)
Time frame: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.
Monitor and record hemoglobin level(g/L), every 2 days in patients, and maintain a record.
hematological parameters like white blood cell count(WBC)
Time frame: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.
Monitor and record white blood cell count( 10⁹/L)every 2 days in patients, and maintain a record.
hematological parameters like platelet count(PLT)
Time frame: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.
Monitor and record platelet count ( 10⁹/L)every 2 days in patients, and maintain a record.
hematological parameters like neutrophil count(ANC)
Time frame: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.
Monitor and record neutrophil count ( 10⁹/L)every 2 days in patients, and maintain a record.
2 secondary outcomes
Incidence of bleeding
Time frame: Up to 30 days after umbilical cord blood treatment
Incidence of infection
Time frame: Up to 30 days after umbilical cord blood treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical cord blood in people with Bone Marrow Suppression, run by Shandong Qilu Stem Cells Engineering Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huaquan Wang (13920745277, wanghuaquan@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with bone marrow suppression grade < II. (time frame: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.