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Estimation of the Safety and Efficiency Transfusion of HLA Matched CBU in Patients With CP

NCT04098029 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-01-18

No results posted yet for this study

Summary

Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion or injury of the immature brain. It is a leading cause of childhood-onset disability.

Many experimental animal studies have revealed that umbilical cord blood is useful to repair neurological injury in the brain.

Based on many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy.

This protocol was developed based on the results of the previously approved protocol of the center NCT03826498 (Allogeneic cord blood transfusion in patients with infantile cerebral palsy), which showed high efficiency in the rehabilitation of patients. The present protocol is intended for revealing the dependence of the clinical effect on the degree of tissue compatibility of umbilical cord blood samples and the recipient

Conditions

  • Cerebral Palsy

Interventions

BIOLOGICAL

Low HLA group CBU infusion

CB-MNC (Cord Blood Mononuclear Cells) infusion from different donors. One dose consists of 2-15х10\^7 cells per 1 kg of patient weight for each infusion. The protocol includes 2 infusions with an interval of 6-x months. HLA compatibility of CB is 3 or fewer by A, B, DRB1 loci.

BIOLOGICAL

High HLA group CBU infusion

CB-MNC (Cord Blood Mononuclear Cells) infusion from different donors. One dose consists of 2-15х10\^7 cells per 1 kg of patient weight for each infusion. The protocol includes 2 infusions with an interval of 6-x months. HLA compatibility of CB is 4 or more by A, B, DRB1 loci.

OTHER

Standard therapy

The standard therapy can include drugs, special psychology training, etc.

Sponsors & Collaborators

  • INBIO, LLC

    collaborator UNKNOWN

  • State-Financed Health Facility "Samara Regional Medical Center Dinasty"

    lead OTHER

Principal Investigators

  • STANISLAV VOLCHKOV, MD, PhD · Medical Centre Dinasty

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2023-12-26
Completion
2024-05-26

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04098029 on ClinicalTrials.gov