MNCs for Bone Marrow Failure After Malignant Diseases Children Chemotherapy

NCT05628272 | Unknown

• 1 other identifier: SDDYYK-KY0913
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cord

Keywords

bone marrow failure; pediatric chemotherapy; mononuclear cells

Outcome Measures

Primary Outcomes (1)

• recovery time of peripheral neutrophils

  Observe the recovery time of peripheral neutrophils

  20days

Secondary Outcomes (1)

• frequency of infection

  20days

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Other: Intravenous infusion of cord blood mononuclear cells; Drug: application of granulocyte stimulating factor

control group

PLACEBO COMPARATOR

granulocyte stimulating factor 5ug/kg/d

Drug: application of granulocyte stimulating factor

Interventions

Intravenous infusion of cord blood mononuclear cells OTHER

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

Experimental group

application of granulocyte stimulating factor DRUG

application of granulocyte stimulating factor

Experimental group; control group

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Those who have received thoracic radiotherapy in the past;

Sponsors & Collaborators

• Qianfoshan Hospital: lead
• Chinese Medical Association: collaborator

Study Sites (1)

Pediatrics, Qianfoshan Hospital

Jinan, Shandong, 251400, China

RECRUITING

MeSH Terms

Conditions

Cone-Rod Dystrophies; Bone Marrow Failure Disorders

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Yan GU, Professor

  Qianfoshan Hospital

  STUDY DIRECTOR

Central Study Contacts

Yan GU, Professor

CONTACT

18053111224; wan009060@163.com

Kai MU, Doctor

CONTACT

15634883957; mkbest@yeah.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: November 28, 2022
• Study Start: October 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)