Allogenic Cord Blood Transfusion in Patients With Cerebral Palsy

NCT ID: NCT03826498

Last Updated: 2023-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-12

Study Completion Date

2024-12-26

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CP CB-MNC injection

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

Group Type EXPERIMENTAL

CP CB-MNC injection

Intervention Type BIOLOGICAL

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

Standard therapy

Intervention Type OTHER

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

Standard therapy

Patients with standard therapy as control group

Group Type OTHER

Standard therapy

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BIOLOGICAL

Standard therapy

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Volchkov Stanislav

Deputy director, Quality assurance director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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STANISLAV VOLCHKOV, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Centre Dinasty

Locations

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Medical Centre Dinasty

Samara, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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STANISLAV VOLCHKOV, MD, PhD

Role: CONTACT

+79608159408

Olga Tyumina, M.D, PhD

Role: CONTACT

Facility Contacts

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Stanislav Volchkov, MD

Role: primary

+78469564455

Pavel Ovchinnikov, MD

Role: backup

+78469564455

Other Identifiers

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12102017

Identifier Type: -

Identifier Source: org_study_id

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