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Phase 2 N=20 Treatment

Allogenic Cord Blood Transfusion in Patients With Autism

Autism Spectrum Disorder · Autism

Bottom Line

View on ClinicalTrials.gov: NCT03786744 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion — 0; 0; 0; 0 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
ASD CB-MNC injection. (Biological); Standard therapy. (Other)
Age
Pediatric · 3+ yrs
Sex
All
Sponsor
State-Financed Health Facility "Samara Regional Medical Center Dinasty"
Primary completion
Oct 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion		 0; 0; 0; 0; 0; 0 —
PRIMARY
Autism Treatment Evaluation Checklist (ATEC).		 14; 14; 11; 14; 7; 16 0.049367 sig
SECONDARY
Cytokine Analysis.		 0; 0; 0; 0; 1.228; 1.279 —
SECONDARY
Immune Status as Determined by Percentage of Peripheral Blood Cells		 61.24; 63.71; 24.33; 25.345; 32.835; 32.55 —
SECONDARY
Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells		 1450.355; 1829.11; 598.48; 654.385; 750.08; 877.095 —

Summary

Autism is one of those disorders in Autism spectrum disorders (ASD), which characterized by social interaction abnormalities, impaired verbal and non-verbal communication, and repetitive, obsessive behavior, while the therapeutic effect of current treatments remains limited progress. The possible reason for ASD is neural hypoperfusion and immune deregulation. 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.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis: autistic type disorder (ASD).
  • Systemic speech underdevelopment
  • The presence of attention deficit hyperactivity disorder as a comorbid state
  • Cognitive impairment

Exclusion Criteria

  • organic pathology of the brain according to CT, MRI
  • 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.
  • Severe form of intellectual disability.
  • Cerebral palsy.
  • epilepsy.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03786744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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