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Testing the safety and effectiveness of stem cells from fat tissue in children with autism spectrum disorder and digestive problems

InvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves children with autism spectrum disorder who also experience ongoing problems with their digestive system, such as stomach pain, diarrhea, or constipation. The treatment being tested uses special cells called mesenchymal stem cells that come from fatty tissue. These cells are obtained from donors, meaning they come from another person rather than the patient themselves. The study will test two different preparations of these cells, known as C2C_ASC66 and C2C_ASC110. Both preparations contain the same type of cells and will be given through an infusion, which means the cells will be delivered directly into the bloodstream through a vein, similar to receiving fluids in a hospital.

The purpose of this study is to check whether this cell treatment is safe for children with autism and digestive problems. The researchers want to carefully monitor any unwanted effects that might occur after the treatment. They will also look at whether the treatment might help improve behavior, communication skills, and quality of life related to digestive symptoms, although the main focus is on safety.

During the study, children will receive the cell treatment and will be closely watched for any reactions or side effects. The study team will use questionnaires to measure changes in daily living skills, communication abilities, and how digestive problems affect quality of life. All children in this study will receive the treatment, as this is an open label study, meaning everyone knows what treatment is being given.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment administration

    You will receive the investigational product through infusion, which means the medication will be delivered directly into your vein over a period of time.

    The product is called C2C_ASC110 or C2C_ASC66, and it contains allogenic adipose-tissue-derived mesenchymal stem cells. These are specialized cells obtained from fat tissue of a donor that may help with your condition.

    The infusion will be administered intravenously, meaning through a needle inserted into a vein in your arm.

  2. Step 2

    Monitoring for adverse reactions

    Throughout the study, you will be monitored for any adverse reactions, which are unwanted or harmful effects that may occur after receiving the treatment.

    Special attention will be given to identifying any serious adverse reactions, which are more severe unwanted effects that require immediate medical attention.

    This monitoring is part of assessing the safety of the treatment for children with autism spectrum disorder and gastrointestinal symptoms.

  3. Step 3

    Assessment of behavioral and communication changes

    You will be asked to complete the Vineland Adaptive Behavior Scales, a questionnaire that measures daily living skills, communication abilities, and social functioning.

    You will also complete the Children Communication Checklist-2, which evaluates various aspects of communication abilities.

    These assessments will be repeated at specific time points to measure any changes that occur during the study.

  4. Step 4

    Evaluation of gastrointestinal symptoms

    You will complete the IBS-QoL questionnaire, which stands for Irritable Bowel Syndrome Quality of Life. This questionnaire measures how gastrointestinal symptoms affect your daily life.

    The questionnaire will be completed at different time points to track any changes in your digestive symptoms and overall quality of life related to these symptoms.

Who can join the trial?

3 criteria

  • The child must be between 6 and 18 years old, including those who are exactly 6 or 18 years old
  • The child must have a confirmed diagnosis of autism spectrum disorder, which is a condition that affects how a person communicates and interacts with others
  • The child must be experiencing ongoing gastrointestinal symptoms, meaning current digestive system problems such as stomach pain, diarrhea, constipation, or other belly-related issues that continue to happen

Who cannot join the trial?

3 criteria

  • The source data does not provide specific exclusion criteria for this clinical trial
  • If you are considering participation in this study, the research team will need to evaluate whether your child meets all requirements during the screening process
  • General factors that often prevent participation in clinical trials may include having certain other medical conditions, taking specific medications, or having allergies to treatment components, but these specific details are not listed in the available information
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Investigated drugs

Allogenic adipose tissue-derived mesenchymal stromal cells are special cells taken from the fatty tissue of a donor and grown in a laboratory. These cells are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. In this study, these cells are being tested to see if they are safe and helpful for children with autism spectrum disorder who also have stomach and digestive problems.

What is already known about the treatment

Allogenic Adipose Tissue-Derived mesenchymal stromal cells – This is an experimental cell-based therapy given through an intravenous infusion (directly into a vein) that is currently being studied in clinical trials for safety and effectiveness. The treatment involves using specially prepared stem cells that are harvested from fatty tissue of donors and grown in a laboratory before being given to patients. These cells are being investigated for their potential to help children with autism spectrum disorder who also experience digestive problems, as the cells may work by reducing inflammation and helping to repair damaged tissues in the gut and possibly affecting brain function. The therapy belongs to a category of treatments called regenerative medicine or cellular therapy, which uses living cells to treat diseases.

Investigated diseases

  • Autism Spectrum Disorder

    Autism spectrum disorder is a developmental condition that affects how a person communicates, interacts with others, and experiences the world around them. It typically appears in early childhood and continues throughout a person's life. People with this condition may have difficulty with social communication and interaction, and often display restricted or repetitive patterns of behavior, interests, or activities. The severity and combination of symptoms can vary widely from person to person. Some individuals may need significant support in their daily lives, while others may need less assistance. The condition is called a spectrum because it encompasses a wide range of symptoms and levels of ability.

  • Gastrointestinal Symptoms

    Gastrointestinal symptoms refer to a group of problems affecting the digestive system, which includes the stomach, intestines, and other organs involved in digestion. These symptoms can include abdominal pain, bloating, diarrhea, constipation, nausea, and changes in bowel habits. They may occur as isolated issues or as part of various digestive conditions. The symptoms can be temporary or long-lasting depending on their underlying cause. Many people experience these symptoms at some point in their lives. The severity can range from mild discomfort to significant disruption of daily activities.

Trial detailsLast updated 9 Oct 2026
Age0-17PhasePhase ITrial ID2025-523699-21-00Estimated enrolment40 patientsSponsorCell to Cure ApS

sourced from the EU Clinical Trials Register and site verification

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