Autism Spectrum Disorder Trial, Recruiting (NCT02168868)

Autism Spectrum Disorder Trial, Recruiting NCT02168868 Sponsor: Benjamin Gesundheit Condition: Autism Spectrum Disorder

Printed from Voxsanity (voxsanity.com.au) — NCT02168868 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Autism Spectrum Disorder

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Boys and girls between the ages of 2 and 12 who have been diagnosed with Autism Spectrum Disorder (ASD)
Children aged 2 to 18 with an ASD diagnosis who are also scheduled to have a stem cell transplant
Babies aged 10 to 19 months who have not been diagnosed with ASD themselves, but have a brother or sister who has been diagnosed with ASD (called "high-risk infants")
Mothers of those high-risk babies described above
Typically developing children aged 2 to 12 with no signs of ASD and no history of ASD in their immediate family
A parent or legal guardian must sign a consent form on behalf of the child

Who may not be able to join:

Children or mothers who have recently (within the last 4 weeks) been treated with steroids or medicines that suppress the immune system
Children or mothers who have had a serious infection or blood poisoning (sepsis) in the last 6 months
Children with ASD who have severe seizures that cannot be controlled with treatment
Children or mothers who have a blood disorder or any form of cancer
Children in the stem cell transplant group who are receiving or planning to receive other immune-related treatments within 6 months before or after their transplant (confirm with trial site)
Participants who the lead researcher believes may not be able to follow the study requirements may also be excluded (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 28 July 2026

This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT02168868

Sponsor: Benjamin Gesundheit

Phase: Not Applicable

Status: Recruiting

Condition: Autism Spectrum Disorder

More information: https://clinicaltrials.gov/study/NCT02168868

Eligibility summary (AI generated)

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Boys and girls between the ages of 2 and 12 who have been diagnosed with Autism Spectrum Disorder (ASD)
Children aged 2 to 18 with an ASD diagnosis who are also scheduled to have a stem cell transplant
Babies aged 10 to 19 months who have not been diagnosed with ASD themselves, but have a brother or sister who has been diagnosed with ASD (called "high-risk infants")
Mothers of those high-risk babies described above
Typically developing children aged 2 to 12 with no signs of ASD and no history of ASD in their immediate family
A parent or legal guardian must sign a consent form on behalf of the child

Who may not be able to join:

Children or mothers who have recently (within the last 4 weeks) been treated with steroids or medicines that suppress the immune system
Children or mothers who have had a serious infection or blood poisoning (sepsis) in the last 6 months
Children with ASD who have severe seizures that cannot be controlled with treatment
Children or mothers who have a blood disorder or any form of cancer
Children in the stem cell transplant group who are receiving or planning to receive other immune-related treatments within 6 months before or after their transplant (confirm with trial site)
Participants who the lead researcher believes may not be able to follow the study requirements may also be excluded (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Not Applicable

Sponsor

Benjamin Gesundheit

Registry

ClinicalTrials.gov

Start date

1 May 2013

Est. completion

1 December 2030

Where this trial is recruiting

🇮🇱 Israel

Primary endpoints

Identification of discriminating proteomic biomarker profile in blood of children with ASD vs. matched TD children; Identification of discriminating proteomic biomarker profiles in blood of high-risk infants, at recruitment vs. after diagnosis of ASD, if diagnosed; Comparison of blood biomarker profiles in ASD children before versus after SCT

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov