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New treatment option for Autism Spectrum Disorder (ASD
Official title Prospective Clinical Study on Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Childhood Autism
ClinicalTrials.gov ID: NCT07243561
What this study is testing
What is hUC-MSC-Exos Nasal Spray?
hUC-MSC-Exos Nasal Spray is an investigational medicine, being studied as a potential treatment for autism spectrum disorder (asd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical study aims to evaluate whether a nasal spray containing exosomes derived from human umbilical cord mesenchymal stem cells (hUC-MSC-EXOs) can safely and effectively improve core symptoms in children aged 3-7 years with autism spectrum disorder (ASD). It is a 24-week, non-randomized, controlled, open-label trial.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 7
You may be able to join if
- Diagnosis meets the ICD-11 ASD criteria or DSM-5 ASD clinical diagnostic standards.
- No significant improvement in core symptoms was observed after ≥3 months of standardized behavioral intervention.
- Score ≥30 on the CARS2, indicating mild-to-moderate or more severe autism.
- Aged 3 (inclusive) to 7 (inclusive) years, regardless of gender
- Voluntary participation in this clinical study, with written informed consent provided by the patient's legal guardian, and willingness to undergo...
You likely can't join if
- History of severe allergic reactions.
- Any severe mental disorder or other types of autism spectrum disorders.
- History of epileptic seizures within the past six months.
- Autism secondary to epilepsy, cerebrovascular disease, or traumatic brain injury.
- Disease severity rated as normal, borderline mental disorder, or mild mental disorder on the Clinical Global Impression scale.
- Moderate or severe extrapyramidal symptoms or tardive dyskinesia.
See the full eligibility criteria
- Diagnosis meets the ICD-11 ASD criteria or DSM-5 ASD clinical diagnostic standards.
- No significant improvement in core symptoms was observed after ≥3 months of standardized behavioral intervention.
- Score ≥30 on the CARS2, indicating mild-to-moderate or more severe autism.
- Aged 3 (inclusive) to 7 (inclusive) years, regardless of gender
- Voluntary participation in this clinical study, with written informed consent provided by the patient's legal guardian, and willingness to undergo examinations, treatment, and cooperate with follow-up visits.
- In the investigator's judgment, the patient is capable of understanding and complying with study requirements.
- History of severe allergic reactions.
- Any severe mental disorder or other types of autism spectrum disorders.
- History of epileptic seizures within the past six months.
- Autism secondary to epilepsy, cerebrovascular disease, or traumatic brain injury.
- Disease severity rated as normal, borderline mental disorder, or mild mental disorder on the Clinical Global Impression scale.
- Moderate or severe extrapyramidal symptoms or tardive dyskinesia.
- Severe self-injurious behavior.
- Active systemic or severe localized infections, including human immunodeficiency virus, syphilis, and hepatitis.
- Autoimmune diseases.
- Major organ impairment.
- Severe pulmonary or hematological diseases, malignancies, or immunodeficiency.
- Concurrent treatments that may interfere with the safety and how well it works evaluation of stem cell therapy.
- Participation in other clinical trials within the past three months.
- Other clinical conditions deemed by investigators as unsuitable for study inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Dongfang, Hainan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 7 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dongfang, Hainan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.