Safety and Efficacy of the Transfusion of UCB in Patients With an ASD Depending on the Degree of HLA Compatibility.
NCT ID: NCT04099381
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
PHASE1/PHASE2
150 participants
INTERVENTIONAL
2019-08-10
2024-05-26
Brief Summary
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The possible reason for ASD is neural hypoperfusion and immune dysregulation. The Human Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy. In this study, the safety and efficacy of hUCB-MNCs infusion will be evaluated in patients with Autism with regarding to HLA compatibility.
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Detailed Description
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Although it has been understood, it can be a question of immune dysregulation. Examination of the inflammatory cytokines, dysfunction of the immune system and the immune system. The Human Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy. Our study suggest that infusion of cord blood mononuclear cells will affect Autism.
This protocol was developed on the basis of the results of the previously approved protocol of the center NCT03786744 (Transfusion of allogeneic cord blood samples in patients with autism spectrum disorders), 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1 Low HLA compatibility
ASD CB-MNC infusion from different donors and standard therapy. CBU with 3 or less HLA compatibility degree in A, B, DRB1 loci will be used.
ASD CB-MNC infusion low level HLA compatibility.
CB-MNC 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 the cord blood is 3 or fewer by A, B, DRB1 loci.
Group 2 High HLA compatibility
ASD CB-MNC infusion from different donors and standard therapy. CBU with 3 or more HLA compatibility degree in A, B, DRB1 loci will be used.
ASD CB-MNC infusion high level HLA compatibility.
CB-MNC 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 the cord blood is 4 or more by A, B, DRB1 loci.
Group 3 Control
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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ASD CB-MNC infusion low level HLA compatibility.
CB-MNC 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 the cord blood is 3 or fewer by A, B, DRB1 loci.
ASD CB-MNC infusion high level HLA compatibility.
CB-MNC 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 the cord blood is 4 or more by A, B, DRB1 loci.
Standard therapy.
The standard therapy can include drugs, special psychology training etc.
Eligibility Criteria
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Exclusion Criteria
* The presence of the following diseases in the history: heart failure at the stage of decompensation, stroke in the history of less than 1 year ago, anemia and other blood diseases;
* Decompensation for chronic and endocrinological diseases;
* Acute viral and bacterial infections during the acute clinical phase of the disease;
* HIV infection, hepatitis B and C;
* Cancer, chemotherapy, and history of cancer;
* Tuberculosis;
* Severe form of intellectual disability as a concomitant disease (diagnosis can be ignored, according to the decision of the Medical Committee of the Center);
* Fragile X chromosome syndrome;
* Epileptic seizures with or without medication in the last 6 months before inclusion in the protocol.
3 Years
14 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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ASD-HLA2019
Identifier Type: -
Identifier Source: org_study_id
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