Allogenic Cord Blood Transfusion in Patients With Cerebral Palsy
NCT ID: NCT03826498
Last Updated: 2023-01-18
Study Results
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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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2018-01-12
2024-12-26
Brief Summary
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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.
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Detailed Description
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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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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CP CB-MNC injection
CP CB-MNC injection from different donors and standard therapy.
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.
Standard therapy
The standard therapy can include drugs, special psychology training etc.
Standard therapy
Patients with standard therapy as control group
Standard therapy
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.
Standard therapy
The standard therapy can include drugs, special psychology training etc.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
1 Year
10 Years
ALL
No
Sponsors
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State-Financed Health Facility "Samara Regional Medical Center Dinasty"
OTHER
Responsible Party
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Volchkov Stanislav
Deputy director, Quality assurance director
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
Countries
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Central Contacts
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Facility Contacts
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Pavel Ovchinnikov, MD
Role: backup
Other Identifiers
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12102017
Identifier Type: -
Identifier Source: org_study_id
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