MNCs for Bone Marrow Failure After Malignant Diseases Children Chemotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Cord
• Intervention / Treatment: Other: Intravenous infusion of cord blood mononuclear cells; Drug: application of granulocyte stimulating factor

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Safety evaluation: Children under treatment who meet any one or more of the following, the study will be terminated or withdrawn: (1) Within 6 hours after the treatment with venous cord blood mononuclear cells, the clinical symptoms that cannot be explained by known causes are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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan GU, Professor; Phone Number: 18053111224; Email: wan009060@163.com
• Study Contact Backup: Name: Kai MU, Doctor; Phone Number: 15634883957; Email: mkbest@yeah.net

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 251400
      • Recruiting
      • Pediatrics, Qianfoshan Hospital
      • Contact: Yan GU, Professor; Phone Number: 18053111224

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≤ 17 years old;
2. Treated in pediatric hematology department from September 2021 to September 2024, patients with bone marrow failure after transplantation;
3. Eastern Cooperative Oncology Group(ECOG) score ≤ 2;
4. 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:

1. Those who have received thoracic radiotherapy in the past;
2. Those who do not meet the above inclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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; 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; Drug: application of granulocyte stimulating factor; application of granulocyte stimulating factor
Placebo Comparator: control group; granulocyte stimulating factor 5ug/kg/d	Drug: application of granulocyte stimulating factor; application of granulocyte stimulating factor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recovery time of peripheral neutrophils	Observe the recovery time of peripheral neutrophils	20days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of infection	frequency of infection	20days

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital
• Collaborators: Chinese Medical Association
• Investigators: Study Director: Yan GU, Professor, Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: November 25, 2022
• First Posted (Actual): November 28, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 25, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: bone marrow failure; pediatric chemotherapy; mononuclear cells
• Additional Relevant MeSH Terms: Bone Marrow Diseases; Hematologic Diseases; Bone Marrow Failure Disorders; Pancytopenia
• Other Study ID Numbers: SDDYYK-KY0913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: To be published in an appropriate form at the complete conclusion of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No