Allogenic Cord Blood Transfusion in Patients With Cerebral Palsy

January 17, 2023 updated by: Volchkov Stanislav, State-Financed Health Facility "Samara Regional Medical Center Dinasty"

Efficiency Evaluation of Allogenic Umbilical Cord Blood Mononuclear Cells (UCB-MNC) Transfusion in Patients With Autism

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cerebral palsy (CP) is a group of neurodevelopmental conditions with abnormal movement and posture resulted from a non-progressive cerebral disturbance. It is the most common cause of motor disability in childhood. Most therapies are palliative rather than restorative. Umbilical cord blood (UCB) may be used as restorative approach for children with CP.

Many experimental animal studies have revealed that UCB is beneficial to improve and repair neurological injuries, this effect achieved due to immune regulation and angiogenesis as well as the neuroprotective effect.

Based on animal studies and some clinical trials, UCB is suggested as a potential therapy for children with CP.

This study is prospective, non randomized (open label) with control group.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: STANISLAV VOLCHKOV, MD, PhD
  • Phone Number: +79608159408
  • Email: bioen07@gmail.com

Study Contact Backup

Study Locations

  • Russian Federation
      • Samara, Russian Federation, 443095
        • Recruiting
        • Medical Centre Dinasty
        • Contact:
        • Contact:
          • Pavel Ovchinnikov, MD
          • Phone Number: +78469564455
        • Principal Investigator:
          • Stanislav Volchkov
        • Sub-Investigator:
          • Pavel Ovchinnikov
        • Sub-Investigator:
          • Alexander Bugakov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Confirmed diagnosis: Cerebral Palsy.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CP CB-MNC injection
CP CB-MNC injection from different donors and standard therapy.
Biological: CP CB-MNC injection
CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.
Other: Standard therapy
The standard therapy can include drugs, special psychology training etc.
Other: Standard therapy
Patients with standard therapy as control group
Other: Standard therapy
The standard therapy can include drugs, special psychology training etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with non-serious and serious adverse events
Time Frame: 6 month
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.
Time Frame: 1, 3, 6 month
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
Time Frame: 1, 3, 6 month
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.
Time Frame: 1, 3, 6 month
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.
Time Frame: 1, 3, 6 month

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Chimerism (longevity) of infused cell
Time Frame: 6 month
Chimerism study to detect the longevity of infused donor cells and predict effectiveness of treatment. This study measure DNA of donor cells will in patients blood at the end of protocol. Absence of donor DNA suggest no chimerism.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2018

Primary Completion (Anticipated)

January 26, 2024

Study Completion (Anticipated)

December 26, 2024

Study Registration Dates

First Submitted

January 22, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

February 1, 2019

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12102017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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