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Trial record 19 of 19 for:    stem cells and autism

Allogenic Cord Blood Transfusion in Patients With Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826498
Recruitment Status : Enrolling by invitation
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Volchkov Stanislav, State-Financed Health Facility "Samara Regional Medical Center Dinasty"

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.


Condition or disease Intervention/treatment Phase
Cerebral Palsy Biological: CP CB-MNC injection Other: Standard therapy Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficiency Evaluation of Allogenic Umbilical Cord Blood Mononuclear Cells (UCB-MNC) Transfusion in Patients With Autism
Actual Study Start Date : January 12, 2018
Estimated Primary Completion Date : December 26, 2020
Estimated Study Completion Date : January 26, 2021

Resource links provided by the National Library of Medicine


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.

Standard therapy
Patients with standard therapy as control group
Other: Standard therapy
The standard therapy can include drugs, special psychology training etc.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826498


Locations
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Russian Federation
Medical Centre Dinasty
Samara, Russian Federation, 443095
Sponsors and Collaborators
State-Financed Health Facility "Samara Regional Medical Center Dinasty"
Investigators
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Principal Investigator: STANISLAV VOLCHKOV, MD, PhD Medical Centre Dinasty

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Responsible Party: Volchkov Stanislav, Deputy director, Quality assurance director, State-Financed Health Facility "Samara Regional Medical Center Dinasty"
ClinicalTrials.gov Identifier: NCT03826498     History of Changes
Other Study ID Numbers: 12102017
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Volchkov Stanislav, State-Financed Health Facility "Samara Regional Medical Center Dinasty":
Cerebral palsy
CP
Cord Blood
Stem cells
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases