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hCT-MSC Infusion for Autism (AIMs Trial)
AIMs Trial Summary
This trial is testing the safety and tolerability of a single intravenous dose of Human Umbilical Cord Tissue Derived Mesenchymal Stromal Cells (hCT-MSC) in adults with autism spectrum disorder (ASD). hCT-MSC is a cell product isolated from umbilical cord tissue. The cells from the cord tissue are processed and expanded in the laboratory and then infused intravenously in a single dose per participant.
AIMs Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAIMs Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AIMs Trial Design
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Who is running the clinical trial?
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- I have cancer that is being treated or was treated with chemotherapy.I do not have any infections that are currently uncontrolled.I am between 18 and 34 years old.I tested negative for Fragile X and my genetic tests don't link to autism.I have access to my own or my child's stored cord blood.I haven't taken systemic steroids for more than 5 days in the last month.You have been diagnosed with Autism Spectrum Disorder (ASD) using the DSM-5 Checklist with the help of the Brief Observation of Symptoms of Autism (BOSA).I have a condition that might need a stem cell transplant in the future.I have a history of autoimmune blood disorders.I have an active infection in my brain or spinal cord.My psychiatric medication has been stable for 2 months, and I don't plan to change it during the study.I have a health condition that could make study treatments risky for me.I can travel to Duke University for my first visit.I have a genetic condition like Fragile X or muscular dystrophy.I do not have a history of uncontrolled seizures or specific severe seizure disorders.My kidney or liver function is not normal, but I don't have Gilbert's disease.I have physical features that suggest a genetic condition, as confirmed by specialists.I have a history of primary immunodeficiency.I have a significant sensory or motor impairment.I am willing and able to attend all study-related appointments.I have a genetic mutation linked to autism.I was exposed to COVID-19 recently or tested positive within the last month but have been symptom-free for 2 weeks.My psychiatric medication has been stable for 2 months, and I don't plan to change it during the study.You are able to travel to Duke University two times (baseline, six months) without a caregiver.I can travel to Duke University for my first visit.I have had cell therapy before.I have used IVIG or other anti-inflammatory drugs, but not NSAIDs.
- Group 1: hCT-MSC infusion
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this research project have open positions for participants?
"Presently, this study is actively seeking participants according to the clinicaltrials.gov website. This trial was first posted on January 24th, 2022 and was last updated September 1st of the same year."
Does the FDA recognize hCT-MSC as a legitimate treatment?
"The data collected thus far suggests that hCT-MSC is a safe treatment option, however this is only based off of initial studies (Phase 1)."
Would I be able to help out with this clinical trial?
"This clinical trial is seeking 12 participants that have been diagnosed with autism spectrum disorder. The ideal candidate will be between 18 and 34 years old, currently stable on psychiatric medication, able to speak English, cognitively able (as determined by testing), and willing to travel to Duke University twice over the course of the study. In addition, they must have a negative result for Fragile X testing and a Social Responsiveness Scale score of 66 or above."
Why was this research project undertaken?
"The primary outcome of this clinical trial is the incidence of unexpected adverse events over a 12-month period. Secondary outcomes include the change in repetitive behavior from baseline to six months, as measured by the Repetitive Behavior Scale Revised, and the change in social ability from baseline to six months, as measured by the Social Responsiveness Scale."
Does the age limit for this trial preclude patients who are over 70 years old?
"This trial is exclusively for patients aged 18-34. Out of the 296 total clinical trials, 248 are for patients younger than this age bracket and 48 are for senior citizens."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Duke University Medical Center: < 48 hours
Average response time
- < 2 Days
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