Autologous Cord Blood Stem Cells for Autism
Condition: Autism
MeSH terms: Autistic Disorder
Intervention: Autologous Cord Blood Stem Cells; Placebo
Intervention description: One infusion of 60 ml syringe of study product; Saline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 2 Years
Maximum age: 7 Years
Healthy volunteers: No

Summary:

      Evaluate the efficacy of one infusion of stem cells from autologous umbilical cord blood in
      patients with autism over six months after infusion as measured by changes in expressive and
      receptive language.

      Also demonstrate improved behavior, learning, and changes in Serum tumor necrosis factor
      alpha (TNF-α), tumor necrosis factor beta (TNF-β), interleukin 1-alpha (IL-1α), interleukin
      1-beta (IL-1β), interleukin 6 (IL-6), interleukin 10 (IL-10), and interleukin 13 (IL-13).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 2 to 7 years of age

          -  Diagnosis of Autistic Disorder as diagnosed by the Diagnostic and Statistical Manual,
             4th Edition, Text Revision (DSM-IV-TR) developmental delays, and ADOS

          -  A sufficient quantity of autologous cord blood stored at Cord Blood Registry that was
             stored and processed using the Thermogenesis AutoXpress Platform

          -  Stable on any current medications for at least 2 months prior to infusion of cord
             blood

          -  Medical records indicating that patient does not have genetic conditions such as
             cerebral palsy, cystic fibrosis, muscular dystrophy, crohns disease, rheumatoid
             disease, fragile X, Retts Syndrome, Angelman Syndrome, tuberous sclerosis, epilepsy,
             or known genetic defects that overlap autism spectrum.

          -  Results of an EEG within 12-months of baseline

          -  English speaking

        Exclusion Criteria:

          -  CNS infection

          -  Extreme prematurity (< 34 weeks gestation)

          -  Severe Cognitive Disability IQ below 45 with autism

          -  Clinical seizure activity within 6 months of baseline

          -  Lennox Gastaut syndrome or infantile spasms

          -  Dravet syndrome

          -  HIV, renal or hepatic impairment

          -  Prior hematological or malignant disease

          -  Fever of 101 F within 2 weeks prior to infusion

          -  Serious CNS infection or trauma

          -  Unwilling to commit to follow-up

          -  Mental illness including schizophrenia

          -  Pervasive Developmental Disorder-Not Otherwise Specified

          -  Asperger's Disorder

          -  Cord blood unit is less than 85% viable, has a TNC of less than 10 million/kg, or
             sterility testing results are positive

          -  Garlic allergy

          -  Previous adverse reaction to Dimethyl Sulfoxide (DMSO)

          -  Maternal medical records indicate communicable diseases including HIV, Hepatitis B or
             C, syphilis, cytomegalovirus (CMV)

          -  Currently taking anti-inflammatory medications

          -  History of asthma who may potentially require treatment with steroids

          -  Inflammatory Disease

          -  Renal/hepatic disease: serum Creatinine > 1.5 mg/dl and total Bilirubin > 1.5 mg/dl

          -  Allergic to diphenhydramine (Benadryl)

          -  Treatment with chelation therapy, hyperbaric oxygen therapy, pig worm therapy, or
             other alternative therapies the investigator deems clinically relevant