Autologous Cord Blood Stem Cells for Autism
Completed · Phase 2 · Has a placebo group
Conditions studied: Autism
In brief
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).
Key facts
- Study ID
- NCT01638819
- Run by
- Sutter Health
- People needed
- 30
- Starts
- 2012-08-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2018-08-20
Who can join
Age: 2 and older, up to 7. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Sutter Pediatric Neurology — Sacramento, California, United States
Full record on ClinicalTrials.gov
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