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Immunoglobulin

Gammaplex 5% IGIV for Autism

Phase 4
Waitlist Available
Led By Isaac Melamed, MD
Research Sponsored by Isaac Melamed
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

If autism is the consequence of a chronic inflammatory process preventing the infant brain from forming the proper neural connections, then treatment that reduces inflammation might have a positive impact on autism. IGIV treatment has been known to suppress inflammation and has been used in the treatment of inflammatory conditions and autoimmune diseases.

Eligible Conditions
  • Autism
  • Asperger Syndrome
  • Pervasive Developmental Disorder
  • Autism Spectrum Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary objective is to assess the efficacy of Gammaplex as an immunomodulatory therapy in autistic children with evidence of immune dysfunction.
Secondary outcome measures
The modulatory effect of IVIG on neuroinflammation will be assessed by laboratory measurements which we believe are indicative of immune dysregulation.
Other outcome measures
To improve development in autistic spectrum

Trial Design

1Treatment groups
Experimental Treatment
Group I: Gammaplex 5% IGIVExperimental Treatment1 Intervention
Gammaplex 5% IGIV administered intravenously

Find a Location

Who is running the clinical trial?

Bio Products LaboratoryOTHER
27 Previous Clinical Trials
448 Total Patients Enrolled
Isaac MelamedLead Sponsor
Isaac Melamed, MDPrincipal InvestigatorIMMUNOe International Clinical Research Centers
4 Previous Clinical Trials
71 Total Patients Enrolled
~2 spots leftby Jul 2025
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