Estimation of the Safety and Efficiency Transfusion of HLA Matched CBU in Patients With CP
NCT ID: NCT04098029
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
150 participants
INTERVENTIONAL
2019-09-01
2024-05-26
Brief Summary
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Many experimental animal studies have revealed that umbilical cord blood is useful to repair neurological injury in the brain.
Based on many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy.
This protocol was developed based on the results of the previously approved protocol of the center NCT03826498 (Allogeneic cord blood transfusion in patients with infantile cerebral palsy), which showed high efficiency in the rehabilitation of patients. The present protocol is intended for revealing the dependence of the clinical effect on the degree of tissue compatibility of umbilical cord blood samples and the recipient
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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
СLINICAL PURPOSES Estimation of the efficiency of the method of transfusion of umbilical blood hematopoietic cells to patients with diagnosed infantile cerebral palsy depending on the degrees of compatibility of donor and recipient.
RESEARCH PURPOSES
1. To develop an algorithm of using the method of transfusion of hematopoietic cells of umbilical cord blood at complex therapy of patients with children's cerebral palsy.
2. Formulate criteria for selecting patients for this method.
3. To analyze the safety and efficacy of umbilical cord blood hematopoietic cells transfusion in patients with cerebral palsy using evaluation scales.
4. To compare the efficacy of treatment of patients depending on the degree of tissue compatibility of the donor and recipient and other laboratory indications.
5. To implement the method of transfusion of umbilical cord blood hematopoietic cells in the complex therapy of patients with cerebral palsy.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
The third group will be the control group. In the control group, 50 patients with similar pathology will be examined, comparable in age, sex and degree of disorder of the type of "paracopies" against the background of standard therapy.
TREATMENT
NONE
Study Groups
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Group 1 Low HLA compatibility
The patients in the first group will receive two CBU of low-level HLA matched infusions within a 6-month interval. The low-level match is 3 or less HLA compatibility degree by A, B, DRB1 loci.
Low HLA group CBU infusion
CB-MNC (Cord Blood Mononuclear Cells) infusion from different donors. One dose consists of 2-15х10\^7 cells per 1 kg of patient weight for each infusion. The protocol includes 2 infusions with an interval of 6-x months. HLA compatibility of CB is 3 or fewer by A, B, DRB1 loci.
Group 2 High HLA compatibility
The patients in the second group will receive two CBU of high-level HLA matched infusions within a 6-month interval. The high-level match is 4 or more HLA compatibility degree by A, B, DRB1 loci.
High HLA group CBU infusion
CB-MNC (Cord Blood Mononuclear Cells) infusion from different donors. One dose consists of 2-15х10\^7 cells per 1 kg of patient weight for each infusion. The protocol includes 2 infusions with an interval of 6-x months. HLA compatibility of CB is 4 or more by A, B, DRB1 loci.
Standard therapy
Patients with standard therapy as a control group
Standard therapy
The standard therapy can include drugs, special psychology training, etc.
Interventions
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Low HLA group CBU infusion
CB-MNC (Cord Blood Mononuclear Cells) infusion from different donors. One dose consists of 2-15х10\^7 cells per 1 kg of patient weight for each infusion. The protocol includes 2 infusions with an interval of 6-x months. HLA compatibility of CB is 3 or fewer by A, B, DRB1 loci.
High HLA group CBU infusion
CB-MNC (Cord Blood Mononuclear Cells) infusion from different donors. One dose consists of 2-15х10\^7 cells per 1 kg of patient weight for each infusion. The protocol includes 2 infusions with an interval of 6-x months. HLA compatibility of CB is 4 or more by A, B, DRB1 loci.
Standard therapy
The standard therapy can include drugs, special psychology training, etc.
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* The presence of the following diseases in history: heart failure in the stage of decompensation, anemia and other blood diseases;
* Decompensation of chronic and endocrinological diseases;
* Acute viral and bacterial infections during the acute clinical phase of the disease;
* HIV infection, hepatitis of B and C types;
* Oncological diseases, chemotherapy in the anamnesis;
* Tuberculosis;
* Confirmed genetic disorders;
* A severe form of intellectual disability as a concomitant disease (diagnosis can be ignored, according to the decision of the Medical Committee of the Center);
* Epileptic seizures with or without medication in the last 6 months before inclusion in the protocol.
1 Year
12 Years
ALL
No
Sponsors
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INBIO, LLC
UNKNOWN
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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Olga Tyumina, MD, PhD
Role: backup
Other Identifiers
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CP-HLA2019
Identifier Type: -
Identifier Source: org_study_id
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