CordNCT05628272
MNCs for Bone Marrow Failure After Malignant Diseases Children Chemotherapy
A study testing Intravenous infusion of cord blood mononuclear cells and application of granulocyte stimulating factor in people with Cord, run by Qianfoshan Hospital at 1 site in China.
Trial summary
This project aims to investigate the therapeutic and repair effects of cord blood mononuclear cells (MNCs) on bone marrow failure after chemotherapy in children with malignant diseases. It is planned to collect 20 malignant children with bone marrow failure after chemotherapy and randomly divide them into two groups. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Cord
- What is being tested?
- Intravenous infusion of cord blood mononuclear cells and application of granulocyte stimulating factor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≤ 17 years old;
- Treated in pediatric hematology department from September 2021 to September 2024, patients with bone marrow failure after transplantation;
- Eastern Cooperative Oncology Group(ECOG) score ≤ 2;
- Sign the informed consent form (< 10 years old, signed by the guardian; ≥ 10 The children and their guardians signed the informed consent form before the selection.
Who cannot join
- Those who have received thoracic radiotherapy in the past;
- Those who do not meet the above inclusion criteria.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Pediatrics, Qianfoshan Hospital
Jinan, Shandong, 251400
Yan GU, Professor, 18053111224
About this study
Official title: Clinical Study of Cord Blood MNCs in the Treatment of Bone Marrow Failure After Chemotherapy in Children With Malignant Diseases
This project aims to investigate the therapeutic and repair effects of cord blood mononuclear cells (MNCs) on bone marrow failure after chemotherapy in children with malignant diseases. It is planned to collect 20 malignant children with bone marrow failure after chemotherapy and randomly divide them into two groups. The umbilical cord blood mononuclear cells were injected, ≥1×10^8 per infusion, once a week, and the recovery time of peripheral blood leukocytes, neutrophils, platelets and hemoglobin was observed. According to the recovery of myelosuppression, stop when the peripheral blood reaches leukocytes>1×10^9/L, neutrophils>0.5×10^9/L, platelets>25×10^9/L, and hemoglobin>60g/L at the same time. Use, share 1-4 times.
Statistical software was used to compare the changes of peripheral blood leukocytes, neutrophils, platelets and hemoglobin before the start of the test (0d) and 1d, 3d, 5d, 7d, 10d, and 14d after the start of the test, as well as the severity of concurrent infections and antibiotic use Time, number of infusions of blood products.
Read the detailed description
The standard of bone marrow failure after chemotherapy is based on theWorld Health Organization(WHO) grade IV myelosuppression standard, that is, peripheral blood white blood cells (WBC) < 1 × 10^9/L, neutrophils (N) <0.5 × 10^9/L, platelets (PLT) <25×10^9/L, hemoglobin (Hb) <60g/L, for more than 2 weeks. It is planned to collect 20 malignant children with bone marrow failure after chemotherapy and randomly divide them into two groups. The umbilical cord blood mononuclear cells were injected, ≥1×10^8 per infusion, once a week, and the recovery time of peripheral blood leukocytes, neutrophils, platelets and hemoglobin was observed. According to the recovery of myelosuppression, when the peripheral blood reaches WBC>1×10^9/L, N>0.5×10^9/L, PLT>25×10^9/L, and Hb>60g/L at the same time, it should be discontinued and used together. 1-4 times.
Safety evaluation: Children under treatment who meet any one or more of the following, the study will be terminated or withdrawn: (1) Within 6 hours after the treatment with venous cord blood mononuclear cells, the clinical symptoms that cannot be explained by known causes are significantly aggravated or In case of deterioration, the trial should be terminated, and appropriate treatment should be carried out. The withdrawn cases should be included in the clinical efficacy evaluation, and the count is invalid; (2) During the treatment and within 6 hours after the treatment, the following conditions that cannot be explained by the known causes occur: severe hypotension, contraction Blood pressure drops ≥20mmHg or systolic blood pressure <70mmHg; severe hypertension, systolic blood pressure rises ≥20mmHg or systolic blood pressure>140mmHg, the test should be terminated; (3) During treatment and within 6 hours after treatment, chills, Patients with fever (body temperature ≥39°C), rash, headache, low back pain and other symptoms should stop the test; (4) If serious adverse events occur, the test should be stopped.
Efficacy evaluation: compare the changes of peripheral blood leukocytes, neutrophils, platelets and hemoglobin before the start of the test (0d) and 1d, 3d, 5d, 7d, 10d, and 14d after the start of the test, as well as the severity of concurrent infection and antibiotic use Time, number of infusions of blood products.
- Conditions
- Cord
- Being tested
- Intravenous infusion of cord blood mononuclear cells, application of granulocyte stimulating factor
- Keywords
- bone marrow failure, pediatric chemotherapy, mononuclear cells
- Medical subject headings
- Cone-Rod Dystrophies, Bone Marrow Failure Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous infusion of cord blood mononuclear cellsOther
On the basis of the application of granulocyte stimulating factor, the research group was given intravenous infusion of umbilical cord blood mononuclear cells, each infusion ≥1×10^8, once a week
application of granulocyte stimulating factorDrug
application of granulocyte stimulating factor
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | granulocyte stimulating factor(5ug/kg/d) +infusion of umbilical cord blood mononuclear cells, each infusion ≥1×10^8, once a week Receives: Other: Intravenous infusion of cord blood mononuclear cells; Drug: application of granulocyte stimulating factor |
| control group | Placebo comparator | granulocyte stimulating factor 5ug/kg/d Receives: Drug: application of granulocyte stimulating factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
recovery time of peripheral neutrophils
Observe the recovery time of peripheral neutrophils
Measured: 20days
Secondary outcomes (1)
frequency of infection
frequency of infection
Measured: 20days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start1 Oct 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CordStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Medical Association
- Responsible party
- Principal investigator, Gu Yan, Qianfoshan Hospital
- Investigators
- Yan GU, Professor, Study director, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628272
- Sponsor's protocol ID
- SDDYYK-KY0913
- Status last verified
- Nov 2022
- First submitted
- 15 Sep 2022
- Last updated
- 28 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be published in an appropriate form at the complete conclusion of the study
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Cord Blood MNCs in the Treatment of Bone Marrow Failure After Chemotherapy in Children With Malignant Diseases
- ClinicalTrials.gov ID
- NCT05628272
- Acronym / sponsor ID
- SDDYYK-KY0913
- Conditions
- Cord
- Keywords
- bone marrow failure, pediatric chemotherapy, mononuclear cells
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Collaborators
- Chinese Medical Association
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 28 Nov 2022 (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.
This project aims to investigate the therapeutic and repair effects of cord blood mononuclear cells (MNCs) on bone marrow failure after chemotherapy in children with malignant diseases. It is planned to collect 20 malignant children with bone marrow failure after chemotherapy and randomly divide them into two groups. The umbilical cord blood mononuclear cells were injected, ≥1×10^8 per infusion, once a week, and the recovery time of peripheral blood leukocytes, neutrophils, platelets and hemoglobin was observed. According to the recovery of myelosuppression, stop when the peripheral blood reaches leukocytes>1×10^9/L, neutrophils>0.5×10^9/L, platelets>25×10^9/L, and hemoglobin>60g/L at the same time. Use, share 1-4 times.
Statistical software was used to compare the changes of peripheral blood leukocytes, neutrophils, platelets and hemoglobin before the start of the test (0d) and 1d, 3d, 5d, 7d, 10d, and 14d after the start of the test, as well as the severity of concurrent infections and antibiotic use Time, number of infusions of blood products.
Detailed description
The standard of bone marrow failure after chemotherapy is based on theWorld Health Organization(WHO) grade IV myelosuppression standard, that is, peripheral blood white blood cells (WBC) < 1 × 10^9/L, neutrophils (N) <0.5 × 10^9/L, platelets (PLT) <25×10^9/L, hemoglobin (Hb) <60g/L, for more than 2 weeks. It is planned to collect 20 malignant children with bone marrow failure after chemotherapy and randomly divide them into two groups. The umbilical cord blood mononuclear cells were injected, ≥1×10^8 per infusion, once a week, and the recovery time of peripheral blood leukocytes, neutrophils, platelets and hemoglobin was observed. According to the recovery of myelosuppression, when the peripheral blood reaches WBC>1×10^9/L, N>0.5×10^9/L, PLT>25×10^9/L, and Hb>60g/L at the same time, it should be discontinued and used together. 1-4 times.
Safety evaluation: Children under treatment who meet any one or more of the following, the study will be terminated or withdrawn: (1) Within 6 hours after the treatment with venous cord blood mononuclear cells, the clinical symptoms that cannot be explained by known causes are significantly aggravated or In case of deterioration, the trial should be terminated, and appropriate treatment should be carried out. The withdrawn cases should be included in the clinical efficacy evaluation, and the count is invalid; (2) During the treatment and within 6 hours after the treatment, the following conditions that cannot be explained by the known causes occur: severe hypotension, contraction Blood pressure drops ≥20mmHg or systolic blood pressure <70mmHg; severe hypertension, systolic blood pressure rises ≥20mmHg or systolic blood pressure>140mmHg, the test should be terminated; (3) During treatment and within 6 hours after treatment, chills, Patients with fever (body temperature ≥39°C), rash, headache, low back pain and other symptoms should stop the test; (4) If serious adverse events occur, the test should be stopped.
Efficacy evaluation: compare the changes of peripheral blood leukocytes, neutrophils, platelets and hemoglobin before the start of the test (0d) and 1d, 3d, 5d, 7d, 10d, and 14d after the start of the test, as well as the severity of concurrent infection and antibiotic use Time, number of infusions of blood products.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Intravenous infusion of cord blood mononuclear cells, Drug: application of granulocyte stimulating factorgranulocyte stimulating factor(5ug/kg/d) +infusion of umbilical cord blood mononuclear cells, each infusion ≥1×10^8, once a week |
| control group | Placebo comparator | Drug: application of granulocyte stimulating factorgranulocyte stimulating factor 5ug/kg/d |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age ≤ 17 years old;
- Treated in pediatric hematology department from September 2021 to September 2024, patients with bone marrow failure after transplantation;
- Eastern Cooperative Oncology Group(ECOG) score ≤ 2;
- Sign the informed consent form (< 10 years old, signed by the guardian; ≥ 10 The children and their guardians signed the informed consent form before the selection.
Key exclusion criteria (2 listed)
- Those who have received thoracic radiotherapy in the past;
- Those who do not meet the above inclusion criteria.
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 |
|---|---|---|
| Intravenous infusion of cord blood mononuclear cellsOn the basis of the application of granulocyte stimulating factor, the research group was given intravenous infusion of umbilical cord blood mononuclear cells, each infusion ≥1×10^8, once a week | Other | Experimental group |
| application of granulocyte stimulating factorapplication of granulocyte stimulating factor | Drug | Experimental group, control group |
Primary outcome
recovery time of peripheral neutrophils
Time frame: 20days
Observe the recovery time of peripheral neutrophils
1 secondary outcome
frequency of infection
Time frame: 20days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- Individual participant dataSharing planned: No. To be published in an appropriate form at the complete conclusion of the study
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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. This study is not recruiting at the moment.
Yan GU, Professor study director
Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous infusion of cord blood mononuclear cells and application of granulocyte stimulating factor in people with Cord, run by Qianfoshan Hospital at 1 site in China.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan GU, Professor (18053111224, wan009060@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recovery time of peripheral neutrophils (time frame: 20days). 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 28 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.