Allogenic Cord Blood Transfusion in Patients With Cerebral Palsy

NCT03826498 | Unknown Phase 2

• 1 other identifier: 12102017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 brain. On the basis of many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy.

Conditions

Cerebral Palsy

Keywords

Cerebral palsy; CP; Cord Blood; Stem cells

Outcome Measures

Primary Outcomes (5)

• Number of participants with non-serious and serious adverse events

  Safety assessment such as adverse events will be registered. Adverse events will be monitored during all trial.

  6 month

• Changes in Standardized Gross Motor Function 66 (GMFM-66) Score for all child.

  GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying \& rolling, sitting, crawling \& kneeling, standing, walking, running \& jumping (range: 0\~100 , Higher value means better gross motor function). We reported changes of GMFM between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones. This test will be acquired for all child.

  1, 3, 6 month

• Changes in Cognitive Neurodevelopmental Outcome for child before 3yrs

  Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (higher value means better mental function: 0 - worst, 178 - best). We reported changes of BSID-II Mental Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.This test will be acquired for child before 3yrs.

  1, 3, 6 month

• Changes in The Infant Toddler Quality of Life Questionnaire for child above 3yrs.

  ITQOL - the 47-item short-form (ITQOL-SF47) developed for use in infants and toddlers from 2-months-to-5 years of age. Form scores physical, mental and social well being/ For each concept, item responses are scored, summed, and transformed on a scale from 0 (worst health) to 100 (best health). Changes in completed questionnaire will be assessed. This test will be acquired for child above 3yrs.

  1, 3, 6 month

• Changes in Ashworth scale score for all child.

  The Ashworth scale (AS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity scoring, where: 0 No increase in tone; 1. Slight increase in tone giving catch when the limb is moved in flexion and extension; 2. More marked increase in tone, but limb is easily flexed; 3. Considerable increases in tone, passive movement difficult; 4. Limb rigid in flexion or extension. This test will be acquired for child above 3yrs.

  1, 3, 6 month

Secondary Outcomes (1)

• Number of Participants with Chimerism (longevity) of infused cell

  6 month

Study Arms (2)

CP CB-MNC injection

EXPERIMENTAL

CP CB-MNC injection from different donors and standard therapy.

Biological: CP CB-MNC injection; Other: Standard therapy

Standard therapy

OTHER

Patients with standard therapy as control group

Other: Standard therapy

Interventions

CP CB-MNC injection BIOLOGICAL

CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.

CP CB-MNC injection

Standard therapy OTHER

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

CP CB-MNC injection; Standard therapy

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- Confirmed diagnosis: Cerebral Palsy.

You may not qualify if:

• the presence of the following diseases in history: heart failure in the stage of decompensation, stroke in history less than 1 year ago, blood diseases;
• decompensation of chronic and endocrinological diseases;
• acute respiratory viral and bacterial infections, period less than 1 month after the acute phase.
• HIV infection, hepatitis B and C.
• oncological diseases, chemotherapy in the anamnesis;
• tuberculosis.

Sponsors & Collaborators

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

Study Sites (1)

Medical Centre Dinasty

Samara, 443095, Russia

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• STANISLAV VOLCHKOV, MD, PhD

  Medical Centre Dinasty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

STANISLAV VOLCHKOV, MD, PhD

CONTACT

+79608159408; bioen07@gmail.com

Olga Tyumina, M.D, PhD

CONTACT

centr123@bk.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director, Quality assurance director

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: February 1, 2019
• Study Start: January 12, 2018
• Primary Completion: January 26, 2024
• Study Completion: December 26, 2024
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

RU (1)