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MNCs for Bone Marrow Failure After Malignant Diseases Children Chemotherapy

Primary Purpose

Cord

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intravenous infusion of cord blood mononuclear cells
application of granulocyte stimulating factor
Sponsored by
Qianfoshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cord focused on measuring bone marrow failure, pediatric chemotherapy, mononuclear cells

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: Those who have received thoracic radiotherapy in the past; Those who do not meet the above inclusion criteria.

Sites / Locations

  • Pediatrics, Qianfoshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

control group

Arm Description

granulocyte stimulating factor(5ug/kg/d) +infusion of umbilical cord blood mononuclear cells, each infusion ≥1×10^8, once a week

granulocyte stimulating factor 5ug/kg/d

Outcomes

Primary Outcome Measures

recovery time of peripheral neutrophils
Observe the recovery time of peripheral neutrophils

Secondary Outcome Measures

frequency of infection
frequency of infection

Full Information

First Posted
September 15, 2022
Last Updated
November 25, 2022
Sponsor
Qianfoshan Hospital
Collaborators
Chinese Medical Association
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1. Study Identification

Unique Protocol Identification Number
NCT05628272
Brief Title
MNCs for Bone Marrow Failure After Malignant Diseases Children Chemotherapy
Official Title
Clinical Study of Cord Blood MNCs in the Treatment of Bone Marrow Failure After Chemotherapy in Children With Malignant Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qianfoshan Hospital
Collaborators
Chinese Medical Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cord
Keywords
bone marrow failure, pediatric chemotherapy, mononuclear cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
granulocyte stimulating factor(5ug/kg/d) +infusion of umbilical cord blood mononuclear cells, each infusion ≥1×10^8, once a week
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
granulocyte stimulating factor 5ug/kg/d
Intervention Type
Other
Intervention Name(s)
Intravenous infusion of cord blood mononuclear cells
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
application of granulocyte stimulating factor
Intervention Description
application of granulocyte stimulating factor
Primary Outcome Measure Information:
Title
recovery time of peripheral neutrophils
Description
Observe the recovery time of peripheral neutrophils
Time Frame
20days
Secondary Outcome Measure Information:
Title
frequency of infection
Description
frequency of infection
Time Frame
20days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Those who have received thoracic radiotherapy in the past; Those who do not meet the above inclusion criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan GU, Professor
Phone
18053111224
Email
wan009060@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kai MU, Doctor
Phone
15634883957
Email
mkbest@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan GU, Professor
Organizational Affiliation
Qianfoshan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Pediatrics, Qianfoshan Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
251400
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan GU, Professor
Phone
18053111224

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
To be published in an appropriate form at the complete conclusion of the study

Learn more about this trial

MNCs for Bone Marrow Failure After Malignant Diseases Children Chemotherapy

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