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hCT-MSC for Autism Spectrum Disorder (IMPACT Trial)
IMPACT Trial Summary
This trial will test if hCT-MSC can improve social communication abilities in children with ASD.
IMPACT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.IMPACT Trial Design
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Who is running the clinical trial?
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- The child has a diagnosed genetic syndrome like Fragile X syndrome, neurofibromatosis, Rett syndrome, tuberous sclerosis, PTEN mutation, cystic fibrosis, muscular dystrophy, or a known genetic defect linked to autism spectrum disorder (ASD).You have a known disorder that affects how your body processes and uses nutrients.You have a condition that weakens your immune system since birth.You have previously had autoimmune blood disorders, like ITP or AIHA.You have another medical condition or illness that may require a stem cell transplant in the future.You are currently using or have used medications that reduce inflammation, except for NSAIDs (like ibuprofen).You have received cell therapy treatment in the past.A person can provide legal consent for medical treatment if they are at least four years old, but have not yet turned 12 years oldYou have a major sensory or motor impairment, like being blind or deaf, or having difficulty moving.The text states that the individual is able to travel to Duke University twice and the parent/guardian is able to participate in interim surveys and interviews.You have a known problem with how your body's mitochondria work.You have a history of epilepsy or seizures that are difficult to control or happen frequently. This includes certain types of epilepsy that start in childhood, like infantile spasms, Lennox-Gastaut syndrome, and Dravet syndrome.You have a current cancer or had a cancer in the past that was treated with chemotherapy.You have an ongoing infection that is not under control.is required for any patient under the age of 18
At least one parent or guardian must give consent for any patient aged 18 or younger.You have been diagnosed with depression, bipolar disorder, schizophrenia, obsessive-compulsive disorder related to bipolar disorder, or Tourette syndrome.
- Group 1: Placebo Infusion
- Group 2: MSC
- 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
Is my eligibility sufficient to join this clinical experiment?
"This research seeks 164 participants, aged 4 to 11 years old, who possess a diagnosis of Autism Spectrum Disorder. In addition to this requirement, potential subjects must be able to attend two visits at Duke University (at baseline and six month intervals), their parent or guardian has the capacity for participating in interim surveys/interviews and provides consent from one parental figure."
How many individuals are eligible to take part in this trial?
"Currently, this clinical trial is not enrolling participants. It was posted on October 12th 2020 and last updated on October 26th 2022. If you are in search of other trials for comparison purposes, 1137 studies recruiting patients with autism spectrum disorder and 33 related to Cord Tissue Mesenchymal Stromal Cells are actively seeking enrolment."
Does this research trial accept participants aged 20 and above?
"According to the official study criteria, only individuals aged 4-11 may take part in this medical research."
How reliable are the therapeutic outcomes of Cord Tissue Mesenchymal Stromal Cells?
"Cord Tissue Mesenchymal Stromal Cells is considered relatively safe, given that this Phase 2 trial has generated supporting evidence of security but not yet efficacy. Consequently, it received a rating of 2 on the scale from 1 to 3."
Is it currently feasible to enroll in this experiment?
"This particular study is no longer accepting volunteers. It was first made available on October 12th 2020 and the last update to the trial design occurred on October 26th 2022. Alternatively, 1137 trials for Autism Spectrum Disorder are actively recruiting participants, as well as 33 studies concerning Cord Tissue Mesenchymal Stromal Cells that need patients too."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How responsive is this trial?
Most responsive sites:
- Duke University Medical Center: < 24 hours
Average response time
- < 2 Days
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